PertussisPhase 2NCT03541499

Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults

A Phase 2 study testing BPZE1 in people with Pertussis and Pertussis Immunisation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Pertussis, Pertussis Immunisation
What is being tested?: BPZE1
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 23 Oct 2018to 15 May 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subjects eligible to participate in this study must meet all inclusion criteria:
Provide written informed consent prior to initiation of any study procedures.
Able to understand and comply with planned study procedures and be available for all study visits.
Males or non-pregnant females, 18-49 years of age, inclusive.
In good health*.
As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days that would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days. This includes no change in chronic prescription medication, dose, or frequency because of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, if it is in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes after enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical and inhaled medications (with the exception of inhaled or nasal corticosteroids within 30 days prior to enrollment), herbals, vitamins, and supplements are permitted.

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Oral temperature is < / = 100 degrees Fahrenheit.
Pulse is 45 to 100 bpm, inclusive*. *Pulse can be 45 to 50 bpm, inclusive, if no other symptoms are present. Otherwise, pulse should be 50-100 bpm.
Systolic blood pressure is 85 to 150 mm Hg, inclusive.
Diastolic blood pressure is 55 to 95 mm Hg, inclusive.
White blood cell count is 3,900 cells/microliter or greater*.
Abnormalities in white blood count, hemoglobin, platelet count, alanine aminotransferase, and serum creatinine that are suspected to be due to laboratory anomalies may be repeated once to ensure accuracy; additionally, otherwise eligible subjects with grade 1 abnormalities in these values may be considered for enrollment if, in the opinion of the investigator (or clinician on the 1572), the abnormalities are not clinically significant and do not pose additional risk to the study or the volunteer.
Hemoglobin is 13.0 g/dL or greater (men) or 11.8 g/dL or greater (women)*. *Abnormalities in white blood count, hemoglobin, platelet count, alanine aminotransferase, and serum creatinine that are suspected to be due to laboratory anomalies may be repeated once to ensure accuracy; additionally, otherwise eligible subjects with grade 1 abnormalities in these values may be considered for enrollment if, in the opinion of the investigator (or clinician on the 1572), the abnormalities are not clinically significant and do not pose additional risk to the study or the volunteer.
Platelet count is 135,000 cells/microliter or greater*.
Abnormalities in white blood count, hemoglobin, platelet count, alanine aminotransferase, and serum creatinine that are suspected to be due to laboratory anomalies may be repeated once to ensure accuracy; additionally, otherwise eligible subjects with grade 1 abnormalities in these values may be considered for enrollment if, in the opinion of the investigator (or clinician on the 1572), the abnormalities are not clinically significant and do not pose additional risk to the study or the volunteer.
Alanine aminotransferase is < 45 U/L (women) or 62 U/L (men)*.
Abnormalities in white blood count, hemoglobin, platelet count, alanine aminotransferase, and serum creatinine that are suspected to be due to laboratory anomalies may be repeated once to ensure accuracy; additionally, otherwise eligible subjects with grade 1 abnormalities in these values may be considered for enrollment if, in the opinion of the investigator (or clinician on the 1572), the abnormalities are not clinically significant and do not pose additional risk to the study or the volunteer.
Serum creatinine is < / = 1.25 mg/dL (men) or 1.11 mg/dL (women)*.
Abnormalities in white blood count, hemoglobin, platelet count, alanine aminotransferase, and serum creatinine that are suspected to be due to laboratory anomalies may be repeated once to ensure accuracy; additionally, otherwise eligible subjects with grade 1 abnormalities in these values may be considered for enrollment if, in the opinion of the investigator (or clinician on the 1572), the abnormalities are not clinically significant and do not pose additional risk to the study or the volunteer.
Negative serum HIV antibody assay.
Women of childbearing potential* must use an acceptable contraception method** from 30 days before study vaccination until 60 days after vaccination.
Not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or < 1 year has passed since the last menses if menopausal.
Includes non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving study vaccination, barrier methods such as condoms or diaphragms/cervical caps with spermicide, effective intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill").
Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.

Who cannot join

Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
Have known or suspected active chronic autoinflammatory condition.
Have known active neoplastic disease (excluding non-melanoma skin cancer) or a history of any hematologic malignancy.
Have a history of persistent asthma, major anatomic nasopharyngeal abnormality, or sinus polyp disease due to chronic sinusitis*.
If a patient has a history of nasopharyngeal surgery such as, but not limited to rhinoplasty, tonsillectomy or sinus surgery, adequate healing time per the judgement of the investigator must occur prior to enrollment.
Have known hepatitis B or hepatitis C infection.

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Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
Currently untreated or clinically unstable (in the opinion of the investigator) schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination.
Have received corticosteroids (including oral, parenteral, inhaled, nasal, or intra-articular) of any dose within 30 days prior to study vaccination.
Individual with PT serum IgG antibodies > / = 20 IU/mL and / or PRN serum IgG antibodies > / = 125 IU/ml.
Unwilling to refrain from smoking tobacco for 28 days post vaccination.
Receipt of immunoglobulin or blood derived products within 90 days of enrollment.
Receipt of a vaccine against pertussis in the past 2 years.
Receipt of a live vaccine within 30 days of study vaccination or an inactivated vaccine within 14 days of study vaccination.
Planned vaccination with a licensed vaccine within 28 days of study vaccination.
History of severe allergic reaction (e.g., anaphylaxis) or Bell's palsy, or Guillain-Barre syndrome, after a previous dose of any diphtheria toxoid-tetanus toxoid-, or pertussis-containing vaccine, or encephalopathy within 7 days of administration of a previous pertussis containing vaccine.
History of a progressive neurologic disorder.
In close contact* with children less than 1 year of age or contact with persons with known immunocompromising conditions.
Close contact includes sharing a household, serving as a healthcare worker, or working professionally in settings with repeated exposures.
Receipt of B. pertussis-active antibiotics* within 7 days prior to vaccination.
B. pertussis active antibiotics include macrolides, fluoroquinolones, trimethoprim-sulfamethoxazole, tetracyclines.
Known hypersensitivity to any component of the study vaccine.
Hypersensitivity to azithromycin, which may be used in the event of ongoing BPZE1 colonization.
Any condition that, in the opinion of the investigator, might interfere with objectives of the study or safety to the individual.
Acute illness, including temperature > 100 degrees Fahrenheit within one week prior to vaccination*.
Enrollment may be postponed if acute illness occurs; subjects must remain within the screening window, however, and must be rescreened if > 30 days elapses prior to enrollment.

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
Nashville, Tennessee, 37232-2573

Other trials in United States

About this study

Official title: A Phase 2A Partially-Blind Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Live Attenuated, Intranasal B. Pertussis Vaccine (BPZE1) in Healthy Adults

This is a randomized, partially blind, placebo controlled, clinical trial evaluating a single intranasal dose of BPZE1 in healthy adults. The study will evaluate a lyophilized formulation of the product, with the goal of testing for the optimal dose for subsequent clinical trials. Fifty healthy adults, 18-49 years of age will be randomized to one of the four following treatment groups in a 3:3:3:1 ratio: 10^7 colony forming units (CFU) of BPZE1 administered by VaxINator device, 10^9 CFU of BPZE1 administered by VaxINator device, placebo administered by VaxINator device, 10^9 CFU of BPZE1 administered by needleless tuberculin syringe. Study duration will be approximately 12 months with a subject participation duration of approximately 6 months. The primary objective of this study is to assess the safety and tolerability of a single intranasal dose of either 10^7 or 10^9 CFU of lyophilized BPZE1 vaccine.

Read the detailed description

This is a phase 2a, single center, randomized, partially blind, placebo controlled, clinical trial evaluating a single intranasal dose of either 10^7 colony forming units (CFU) or 10^9 CFU of BPZE1 in healthy adults. The study will evaluate a lyophilized formulation of the product, with the goal of testing for the optimal dose for subsequent clinical trials. Fifty healthy adults, 18-49 years of age will be randomized to one of the four following treatment groups in a 3:3:3:1 ratio: 10^7 CFU of BPZE1 administered by VaxINator device, 10^9 CFU of BPZE1 administered by VaxINator device, placebo administered by VaxINator device, 10^9 CFU of BPZE1 administered by needleless tuberculin syringe. Study duration will be approximately 12 months with a subject participation duration of approximately 6 months. The primary objective of this study is to assess the safety and tolerability of a single intranasal dose of either 10^7 or 10^9 CFU of lyophilized BPZE1 vaccine. The secondary objectives of this study are: 1) to assess the humoral immunogenicity of lyophilized BPZE1 vaccine at Day 15, Day 29 and Day 181 following receipt of one intranasal dose of 10^7 or 10^9 CFU of BPZE1; 2) to assess mucosal immunogenicity of lyophilized BPZE1 vaccine at Day 29 and Day 181 following receipt of one intranasal dose of 10^7 or 10^9 CFU of BPZE1; 3) to evaluate nasal clearance of BPZE1 by culture at Day 29 (and if still positive, at Day 46) following receipt of one intranasal dose of lyophilized BPZE1 vaccine of 10^7 or 10^9 CFU of BPZE1.

Conditions: Pertussis, Pertussis Immunisation
Being tested: BPZE1, Placebo
Keywords: B. pertussis Vaccine, BPZE1, Immunogenicity, Safety
Medical subject headings: Whooping Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BPZE1Biological
Lyophilized, live-attenuated Bordetella pertussis vaccine reconstituted with sterile water for injection (SWFI) and administered as a single intranasal dose of either 10^7 colony forming units (CFU) or 10^9 CFU.
PlaceboOther
The placebo consists of the same constituents in the same quantities as the BPZE1 investigational vaccines, absent the attenuated B. pertussis cells, reconstituted with sterile water for injection (SWFI).

Study groups in NCT03541499
Study group	Role	What they receive
Group 1	Experimental	800 microliters (10^7 CFU) of B. pertussis vaccine (BPZE1) administered intranasally with the VaxINator device on Day 1, n=15 Receives: Biological: BPZE1
Group 2	Experimental	800 microliters (10^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1, n=15 Receives: Biological: BPZE1
Group 3	Placebo comparator	800 microliters of Placebo administered intranasally with the VaxINator device on Day 1, n=15 Receives: Other: Placebo
Group 4	Experimental	800 microliters (10^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1, n=5 Receives: Biological: BPZE1

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Experiencing Adverse Events of Special Interest (AESIs)
AESIs included medically attended wheezing events given the route of study product administration and the nature of the study product.
Measured: Day 1 through Day 29
Number of Participants Experiencing New Onset Chronic Medical Conditions (NOCMCs)
NOCMCs are defined as new medical conditions, not present at the time of screening or enrollment, that require ongoing medical care and intervention.
Measured: Day 1 through Day 181
Number of Participants Experiencing Serious Adverse Events (SAEs)
An adverse event was considered serious if, in the view of either the site principal investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect, or, when, based upon appropriate medical judgment they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Measured: Day 1 through Day 181
Number of Participants Experiencing Solicited Local Reactogenicity Adverse Events (AEs)
The solicited local reactogenicity events included runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore/irritated throat, cough, and shortness of breath/wheezing.
Measured: Day 1 through Day 15
Number of Participants Experiencing Solicited Systemic Reactogenicity AEs
The solicited systemic reactogenicity events included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and rash/hypersensitivity.
Measured: Day 1 through Day 15
Number of Participants Experiencing Unsolicited Non-Serious AEs
Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Unsolicited non-serious AEs were documented and reported from the time of vaccination through Day 29.
Measured: Day 1 through Day 29
Number of Participants Experiencing Severe Solicited Local Reactogenicity Adverse Events
Solicited local reactogenicity events include runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore/irritated throat, cough, and shortness of breath/wheezing. They were graded as grade 1 (mild), grade 2 (moderate), or grade 3 (severe). Severe local events were those that required medical care or caused significant discomfort that prevented daily activity, including sore/irritated throat preventing eating or drinking and cough preventing sleep. Severe epistaxis events were bleeding events that required a medical encounter. Severe stuffy nose/congestion events caused the participant to be unable to breathe through the nose or to seek medical care.
Measured: Day 1 through Day 15
Number of Participants Experiencing Severe Solicited Systemic Reactogenicity AEs
Solicited systemic reactogenicity events include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and rash/hypersensitivity. They were graded as grade 1 (mild), grade 2 (moderate), and grade 3 (severe). For all symptoms except rash and fever, an event was considered severe if it caused significant interference and prevented daily activity. Severe rash/hypersensitivity events were those that caused generalized urticaria, anaphylaxis, or angioedema or localized urticaria that required medical encounter. Severe fever was a temperature exceeding 38.9°C.
Measured: Day 1 through Day 15

Secondary outcomes (28)

Geometric Mean Fold Rise From Screening of the Ratio of Filamentous Hemagglutinin-specific IgA (FHA-IgA) to Total IgA by Nasal Aspirate
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to filamentous hemagglutinin (FHA) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL.
The ratio of FHA-IgA to total mucosal IgA was computed for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant. The geometric mean fold rise of the ratio was calculated for each study arm.
Measured: Screening, Day 29, Day 181
Geometric Mean Fold Rise From Screening of the Ratio of Fimbriae-Specific IgA (FIM-IgA) to Total IgA by Nasal Aspirate
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to fimbriae 2/3 (FIM) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL.
The ratio of FIM-IgA to total mucosal IgA was computed for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant. The geometric mean fold rise of the ratio was calculated for each study arm.
Measured: Screening, Day 29, and Day 181
Geometric Mean Fold Rise From Screening of the Ratio of Pertactin-Specific IgA (PRN-IgA) to Total IgA by Nasal Aspirate
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to pertactin (PRN) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL.
The ratio of PRN-IgA to total mucosal IgA was computed for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant. The geometric mean fold rise of the ratio was calculated for each study arm.
Measured: Screening, Day 29, and Day 181
Geometric Mean Fold Rise From Screening of the Ratio of Pertussis Toxin-Specific IgA (PT-IgA) to Total IgA by Nasal Aspirate
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to pertussis toxin (PT) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL.
The ratio of PT-IgA to total mucosal IgA was computed for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant. The geometric mean fold rise of the ratio was calculated for each study arm.
Measured: Screening, Day 29, and Day 181
Geometric Mean Fold Rise From Baseline Serum IgA and Serum IgG ELISA Titers to Filamentous Hemagglutinin (FHA)
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to perform a bead-based assay to measure serum IgA and serum IgG levels (in ELISA units/mL) to filamentous hemagglutinin (FHA) pertussis antigen.
The fold rise in FHA-IgA from baseline was calculated for each participant and the geometric mean of the fold rise was calculated for each study arm.
Measured: Day 1, Day 15, Day 29, and Day 181
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Fimbriae 2/3 (FIM)
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to perform a bead-based assay to measure serum IgA levels and serum IgG levels (in ELISA units/mL) to fimbriae 2/3 (FIM) pertussis antigen.
The fold rise in FIM-IgA and FIM-IgG from baseline was calculated for each participant and the geometric mean of the fold rise was calculated for each study arm.
Measured: Day 1, Day 15, Day 29, and Day 181
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Pertactin (PRN)
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to perform a bead-based assay to measure serum IgA and serum IgG levels (in ELISA units/mL) to pertactin (PRN) pertussis antigen.
The fold rise in PRN-IgA and PRN-IgG from baseline was calculated for each participant and the geometric mean of the fold rise was calculated for each study arm.
Measured: Day 1, Day 15, Day 29, and Day 181
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Pertussis Toxin (PT)
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to perform a bead-based assay to measure serum IgA and serum IgG levels (in ELISA units/mL) to pertussis toxin (PT) pertussis antigen.
The fold rise in PT-IgA and PT-IgG from baseline was calculated for each participant and the geometric mean of the fold rise was calculated for each study arm.
Measured: Day 1, Day 15, Day 29, and Day 181
Geometric Mean Titer by Serum IgA and Serum IgG to Fimbriae 2/3
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure serum IgA and serum IgG levels (in ELISA units/mL) to fimbriae 2/3 (FIM) pertussis antigen via a bead-based assay. The geometric mean FIM-IgA titer and FIM-IgG titer were calculated for each study arm.
Measured: Day 1, Day 15, Day 29, and Day 181
Geometric Mean Titer by Serum IgA and Serum IgG to Pertactin
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure serum IgA levels and serum IgG levels (in ELISA units/mL) to pertactin (PRN) pertussis antigen via a bead-based assay. The geometric mean PRN-IgA titer and PRN-IgG titer were calculated for each study arm.
Measured: Day 1, Day 15, Day 29, and Day 181
Geometric Mean Titer by Serum IgA and Serum IgG to Pertussis Toxin
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure serum IgA levels and serum IgG levels (in ELISA units/mL) to pertussis toxin (PT) pertussis antigen via a bead-based assay. The geometric mean PT-IgA titer and PT-IgG titer were calculated for each study arm.
Measured: Day 1, Day 15, Day 29, and Day 181
Percentage of Participants Achieving Seroconversion to One or More Pertussis Antigens as Measured by Serum IgA or Serum IgG Levels
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure via a bead-based assay serum IgA and serum IgG levels (in ELISA units/mL) to pertussis toxin, filamentous hemagglutinin, pertactin, and fimbriae 2/3 pertussis antigens.
Seroconversion was defined as at least a 2-fold rise in antigen-specific IgA or antigen-specific IgG levels post-baseline compared to baseline levels. The percentage of participants who seroconverted to at least one pertussis antigen at each and across immunogenicity timepoints (Day 15, Day 29, and Day 181) was calculated.
Measured: Day 15, Day 29, and Day 181
Percentage of Participants Achieving Seroconversion to Two or More Pertussis Antigens as Measured by Serum IgA or Serum IgG Levels
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure via a bead-based assay serum IgA and serum IgG levels (in ELISA units/mL) to pertussis toxin, filamentous hemagglutinin, pertactin, and fimbriae 2/3 pertussis antigens.
Seroconversion was defined as at least a 2-fold rise in antigen-specific IgA levels or antigen-specific IgG levels post-baseline compared to baseline levels. The percentage of participants who seroconverted to at least two pertussis antigens at each and across all immunogenicity timepoints (Day 15, Day 29, and Day 181) was calculated.
Measured: Day 15, Day 29, and Day 181
Percentage of Participants Achieving Seroconversion to One or More Pertussis Antigens as Measured by the Ratio of Antigen-Specific Mucosal IgA Levels to Total Mucosal IgA Levels
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to pertussis vaccine antigens via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL.
The titer ratio of antigen-specific IgA to total mucosal IgA was computed for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant.
Seroconversion was defined as at least a 2-fold rise in antigen-specific titer ratios post-baseline compared to baseline titer ratios. The percentage of participants who seroconverted to at least one pertussis antigen at each and any immunogenicity timepoint was calculated.
Measured: Day 29 and Day 181
Percentage of Participants With Detectable B. Pertussis From Nasopharyngeal Cultures
Colonization of live B. pertussis organism was assessed from a nasopharyngeal swab performed 28 days after vaccine administration (Day 29) to ensure all participants were cleared of colonization. Standard microbiologic techniques were used to assess the presence of B. pertussis by culture.
If any participants were positive for B. pertussis culture at Day 29, they were asked to return at Day 46 for a repeat culture. If the participant was not positive for B. pertussis at Day 29, no subsequent nasopharyngeal samples for culture were collected.
Measured: Day 29 and Day 46
Percentage of Participants Achieving Seroconversion to Filamentous Hemagglutinin as Measured by Serum IgA and Serum IgG Levels
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure via a bead-based assay serum IgA levels and serum IgG levels (in ELISA units/mL) to filamentous hemagglutinin (FHA) pertussis antigen.
Seroconversion was defined as at least a 2-fold rise in antigen-specific IgA and IgG levels post-baseline compared to baseline levels. The percentage of participants who seroconverted to FHA-IgA and FHA-IgG at any and each immunogenicity timepoint (Day 15, Day 29, and Day 181) was calculated.
Measured: Day 15, Day 29, and Day 181
Percentage of Participants Achieving Seroconversion to Fimbriae 2/3 as Measured by Serum IgA and Serum IgG Levels
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure via a bead-based assay serum IgA and serum IgG levels (in ELISA units/mL) to fimbriae 2/3 (FIM) pertussis antigen.
Seroconversion was defined as at least a 2-fold rise in antigen-specific IgA levels and IgG levels post-baseline compared to baseline levels. The percentage of participants who seroconverted to FIM-IgA or FIM-IgG at any and each immunogenicity timepoint (Day 15, Day 29, or and Day 181) was calculated.
Measured: Day 15, Day 29, and Day 181
Geometric Mean Titer Ratio of Mucosal FHA-IgA to Total IgA by Nasal Aspirate
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to filamentous hemagglutinin (FHA) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL.
The ratio of FHA-IgA to total mucosal IgA was computed for each participant and the geometric mean of the ratio was calculated for each study arm.
Measured: Screening, Day 29, Day 181
Geometric Mean Titer Ratio of Mucosal FIM-IgA to Total IgA by Nasal Aspirate
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to fimbriae 2/3 (FIM) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL.
The ratio of FIM-IgA to total mucosal IgA was computed for each participant and the geometric mean of the ratio was calculated for each study arm.
Measured: Screening, Day 29, Day 181
Geometric Mean Titer Ratio of Mucosal PRN-IgA to Total IgA by Nasal Aspirate
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to pertactin (PRN) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL.
The ratio of PRN-IgA to total mucosal IgA was computed for each participant and the geometric mean of the ratio was calculated for each study arm.
Measured: Screening, Day 29, Day 181
Geometric Mean Titer Ratio of Mucosal PT-IgA to Total IgA by Nasal Aspirate
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to pertussis toxin (PT) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL.
The ratio of PT-IgA to total mucosal IgA was computed for each participant and the geometric mean of the ratio was calculated for each study arm.
Measured: Screening, Day 29, and Day 181
Geometric Mean Titer by Serum IgA and Serum IgG to Filamentous Hemagglutinin
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure serum IgA and serum IgG levels (in ELISA units/mL) to filamentous hemagglutinin (FHA) pertussis antigen via a bead-based assay. The geometric mean FHA-IgA titer and FHA-IgG titer were calculated for each study arm.
Measured: Day 1, Day 15, Day 29, and Day 181
Percentage of Participants Achieving Seroconversion to Pertactin as Measured by Serum IgA and Serum IgG Levels
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure via a bead-based assay serum IgA and serum IgG levels (in ELISA units/mL) to pertactin (PRN) pertussis antigen.
Seroconversion was defined as at least a 2-fold rise in antigen-specific IgA and antigen-specific IgG levels post-baseline compared to baseline levels. The percentage of participants who seroconverted to PRN-IgA and PRN-IgG at any and each immunogenicity timepoint (Day 15, Day 29, or Day 181) were calculated.
Measured: Day 15, Day 29, and Day 181
Percentage of Participants Achieving Seroconversion to Pertussis Toxin as Measured by Serum IgA and Serum IgG Levels
Approximately 10 mL of venous blood was collected from participants immediately prior to the first study vaccination on Day 1 (baseline), Day 15, Day 29, and Day 181 to measure via a bead-based assay serum IgA and serum IgG levels (in ELISA units/mL) to pertussis toxin (PT) antigen.
Seroconversion was defined as at least a 2-fold rise in antigen-specific IgA/IgG levels post-baseline compared to baseline levels. The percentage of participants who seroconverted to PT-IgA and PT-IgG at any and each immunogenicity timepoint (Day 15, Day 29, or and Day 181) was calculated.
Measured: Day 15, Day 29, and Day 181
Percentage of Participants Achieving Seroconversion to Filamentous Hemagglutinin as Measured by Mucosal IgA Levels
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to filamentous hemagglutinin (FHA) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL.
The titer ratio of antigen-specific IgA to total mucosal IgA was computed for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant.
Seroconversion was defined as at least a 2-fold rise in antigen-specific titer ratios post-baseline compared to baseline titer ratios. The percentage of participants who seroconverted FHA-IgA at each and any immunogenicity timepoint (Day 29 or Day 181) was calculated.
Measured: Day 29 and Day 181
Percentage of Participants Achieving Seroconversion to Fimbriae 2/3 as Measured by Mucosal IgA Levels
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to fimbriae 2/3 (FIM) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL.
The titer ratio of antigen-specific IgA to total mucosal IgA was computed for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant.
Seroconversion was defined as at least a 2-fold rise in antigen-specific titer ratios post-baseline compared to baseline titer ratios. The percentage of participants who seroconverted FIM-IgA at each and any immunogenicity timepoint (Day 29 and Day 181) was calculated.
Measured: Day 29 and Day 181
Percentage of Participants Achieving Seroconversion to Pertactin as Measured by Mucosal IgA Levels
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to pertactin (PRN) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL.
The titer ratio of antigen-specific IgA to total mucosal IgA was computed for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant.
Seroconversion was defined as at least a 2-fold rise in antigen-specific titer ratios post-baseline compared to baseline titer ratios. The percentage of participants who seroconverted PRN-IgA at each and any immunogenicity timepoint (Day 29 and Day 181) was calculated.
Measured: Day 29 and Day 181
Percentage of Participants Achieving Seroconversion to Pertussis Toxin as Measured by Mucosal IgA Levels
Nasal aspirate samples were collected from all participants at screening (baseline), Day 29, and Day 181 to measure total mucosal IgA levels via ELISA assay and mucosal IgA levels to pertussis toxin (PT) pertussis antigen via a bead-based assay. Total mucosal IgA levels were reported in µg/mL; antigen-specific IgA results were reported in ELISA units/mL.
The titer ratio of antigen-specific IgA to total mucosal IgA was calculated for each participant at each time point, and the fold rise from baseline of this ratio was subsequently calculated for each participant.
Seroconversion was defined as at least a 2-fold rise in antigen-specific titer ratios post-baseline compared to baseline titer ratios. The percentage of participants who seroconverted PT-IgA at each immunogenicity timepoint (Day 29 and Day 181) was calculated.
Measured: Day 29 and Day 181

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 201815 May 2020

First posted30 May 2018
Study start23 Oct 2018
Primary completion15 May 2020
Study completion15 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PertussisStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03541499
Sponsor's protocol ID: 17-0010
Status last verified: 18 Aug 2021
First submitted: 17 May 2018
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization

All Pertussis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2A Partially-Blind Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Live Attenuated, Intranasal B. Pertussis Vaccine (BPZE1) in Healthy Adults
ClinicalTrials.gov ID: NCT03541499
Acronym / sponsor ID: 17-0010
Conditions: Pertussis, Pertussis Immunisation
Keywords: B. pertussis Vaccine, BPZE1, Immunogenicity, Safety
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: 23 Oct 2018 (actual)
Primary completion: 15 May 2020 (actual)
Study completion: 15 May 2020 (actual)
First posted: 30 May 2018 (actual)
Results: Posted 3 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Group 1	Experimental	Biological: BPZE1800 microliters (10^7 CFU) of B. pertussis vaccine (BPZE1) administered intranasally with the VaxINator device on Day 1, n=15
Group 2	Experimental	Biological: BPZE1800 microliters (10^9 CFU) of BPZE1 administered intranasally with the VaxINator device on Day 1, n=15
Group 3	Placebo comparator	Other: Placebo800 microliters of Placebo administered intranasally with the VaxINator device on Day 1, n=15
Group 4	Experimental	Biological: BPZE1800 microliters (10^9 CFU) of BPZE1 administered intranasally with a needleless tuberculin syringe on Day 1, n=5

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (24 listed)

Provide written informed consent prior to initiation of any study procedures.
Able to understand and comply with planned study procedures and be available for all study visits.
Males or non-pregnant females, 18-49 years of age, inclusive.
In good health*.
As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days that would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days. This includes no change in chronic prescription medication, dose, or frequency because of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, if it is in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes after enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical and inhaled medications (with the exception of inhaled or nasal corticosteroids within 30 days prior to enrollment), herbals, vitamins, and supplements are permitted.

Key exclusion criteria (27 listed)

Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
Have known or suspected active chronic autoinflammatory condition.
Have known active neoplastic disease (excluding non-melanoma skin cancer) or a history of any hematologic malignancy.
Have a history of persistent asthma, major anatomic nasopharyngeal abnormality, or sinus polyp disease due to chronic sinusitis*.
If a patient has a history of nasopharyngeal surgery such as, but not limited to rhinoplasty, tonsillectomy or sinus surgery, adequate healing time per the judgement of the investigator must occur prior to enrollment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BPZE1Lyophilized, live-attenuated Bordetella pertussis vaccine reconstituted with sterile water for injection (SWFI) and administered as a single intranasal dose of either 10^7 colony forming units (CFU) or 10^9 CFU.	Biological	Group 1, Group 2, Group 4
PlaceboThe placebo consists of the same constituents in the same quantities as the BPZE1 investigational vaccines, absent the attenuated B. pertussis cells, reconstituted with sterile water for injection (SWFI).	Other	Group 3

Primary outcome

Number of Participants Experiencing Adverse Events of Special Interest (AESIs)
Time frame: Day 1 through Day 29
AESIs included medically attended wheezing events given the route of study product administration and the nature of the study product.
Number of Participants Experiencing New Onset Chronic Medical Conditions (NOCMCs)
Time frame: Day 1 through Day 181
NOCMCs are defined as new medical conditions, not present at the time of screening or enrollment, that require ongoing medical care and intervention.
Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Day 1 through Day 181
An adverse event was considered serious if, in the view of either the site principal investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect, or, when, based upon appropriate medical judgment they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Number of Participants Experiencing Solicited Local Reactogenicity Adverse Events (AEs)
Time frame: Day 1 through Day 15
The solicited local reactogenicity events included runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore/irritated throat, cough, and shortness of breath/wheezing.
Number of Participants Experiencing Solicited Systemic Reactogenicity AEs
Time frame: Day 1 through Day 15
The solicited systemic reactogenicity events included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and rash/hypersensitivity.
Number of Participants Experiencing Unsolicited Non-Serious AEs
Time frame: Day 1 through Day 29
Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Unsolicited non-serious AEs were documented and reported from the time of vaccination through Day 29.
Number of Participants Experiencing Severe Solicited Local Reactogenicity Adverse Events
Time frame: Day 1 through Day 15
Solicited local reactogenicity events include runny nose, stuffy nose/congestion, nasal pain/irritation, epistaxis, sneezing, sinus pressure/pain, sore/irritated throat, cough, and shortness of breath/wheezing. They were graded as grade 1 (mild), grade 2 (moderate), or grade 3 (severe). Severe local events were those that required medical care or caused significant discomfort that prevented daily activity, including sore/irritated throat preventing eating or drinking and cough preventing sleep. Severe epistaxis events were bleeding events that required a medical encounter. Severe stuffy nose/congestion events caused the participant to be unable to breathe through the nose or to seek medical care.
Number of Participants Experiencing Severe Solicited Systemic Reactogenicity AEs
Time frame: Day 1 through Day 15
Solicited systemic reactogenicity events include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and rash/hypersensitivity. They were graded as grade 1 (mild), grade 2 (moderate), and grade 3 (severe). For all symptoms except rash and fever, an event was considered severe if it caused significant interference and prevented daily activity. Severe rash/hypersensitivity events were those that caused generalized urticaria, anaphylaxis, or angioedema or localized urticaria that required medical encounter. Severe fever was a temperature exceeding 38.9°C.

28 secondary outcomes

Geometric Mean Fold Rise From Screening of the Ratio of Filamentous Hemagglutinin-specific IgA (FHA-IgA) to Total IgA by Nasal Aspirate
Time frame: Screening, Day 29, Day 181
Geometric Mean Fold Rise From Screening of the Ratio of Fimbriae-Specific IgA (FIM-IgA) to Total IgA by Nasal Aspirate
Time frame: Screening, Day 29, and Day 181
Geometric Mean Fold Rise From Screening of the Ratio of Pertactin-Specific IgA (PRN-IgA) to Total IgA by Nasal Aspirate
Time frame: Screening, Day 29, and Day 181
Geometric Mean Fold Rise From Screening of the Ratio of Pertussis Toxin-Specific IgA (PT-IgA) to Total IgA by Nasal Aspirate
Time frame: Screening, Day 29, and Day 181
Geometric Mean Fold Rise From Baseline Serum IgA and Serum IgG ELISA Titers to Filamentous Hemagglutinin (FHA)
Time frame: Day 1, Day 15, Day 29, and Day 181
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Fimbriae 2/3 (FIM)
Time frame: Day 1, Day 15, Day 29, and Day 181
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Pertactin (PRN)
Time frame: Day 1, Day 15, Day 29, and Day 181
Geometric Mean Fold Rise From Baseline of Serum IgA and Serum IgG ELISA Titers to Pertussis Toxin (PT)
Time frame: Day 1, Day 15, Day 29, and Day 181
Geometric Mean Titer by Serum IgA and Serum IgG to Fimbriae 2/3
Time frame: Day 1, Day 15, Day 29, and Day 181
Geometric Mean Titer by Serum IgA and Serum IgG to Pertactin
Time frame: Day 1, Day 15, Day 29, and Day 181
Geometric Mean Titer by Serum IgA and Serum IgG to Pertussis Toxin
Time frame: Day 1, Day 15, Day 29, and Day 181
Percentage of Participants Achieving Seroconversion to One or More Pertussis Antigens as Measured by Serum IgA or Serum IgG Levels
Time frame: Day 15, Day 29, and Day 181
Percentage of Participants Achieving Seroconversion to Two or More Pertussis Antigens as Measured by Serum IgA or Serum IgG Levels
Time frame: Day 15, Day 29, and Day 181
Percentage of Participants Achieving Seroconversion to One or More Pertussis Antigens as Measured by the Ratio of Antigen-Specific Mucosal IgA Levels to Total Mucosal IgA Levels
Time frame: Day 29 and Day 181
Percentage of Participants With Detectable B. Pertussis From Nasopharyngeal Cultures
Time frame: Day 29 and Day 46
Percentage of Participants Achieving Seroconversion to Filamentous Hemagglutinin as Measured by Serum IgA and Serum IgG Levels
Time frame: Day 15, Day 29, and Day 181
Percentage of Participants Achieving Seroconversion to Fimbriae 2/3 as Measured by Serum IgA and Serum IgG Levels
Time frame: Day 15, Day 29, and Day 181
Geometric Mean Titer Ratio of Mucosal FHA-IgA to Total IgA by Nasal Aspirate
Time frame: Screening, Day 29, Day 181
Geometric Mean Titer Ratio of Mucosal FIM-IgA to Total IgA by Nasal Aspirate
Time frame: Screening, Day 29, Day 181
Geometric Mean Titer Ratio of Mucosal PRN-IgA to Total IgA by Nasal Aspirate
Time frame: Screening, Day 29, Day 181
Geometric Mean Titer Ratio of Mucosal PT-IgA to Total IgA by Nasal Aspirate
Time frame: Screening, Day 29, and Day 181
Geometric Mean Titer by Serum IgA and Serum IgG to Filamentous Hemagglutinin
Time frame: Day 1, Day 15, Day 29, and Day 181
Percentage of Participants Achieving Seroconversion to Pertactin as Measured by Serum IgA and Serum IgG Levels
Time frame: Day 15, Day 29, and Day 181
Percentage of Participants Achieving Seroconversion to Pertussis Toxin as Measured by Serum IgA and Serum IgG Levels
Time frame: Day 15, Day 29, and Day 181
Percentage of Participants Achieving Seroconversion to Filamentous Hemagglutinin as Measured by Mucosal IgA Levels
Time frame: Day 29 and Day 181
Percentage of Participants Achieving Seroconversion to Fimbriae 2/3 as Measured by Mucosal IgA Levels
Time frame: Day 29 and Day 181
Percentage of Participants Achieving Seroconversion to Pertactin as Measured by Mucosal IgA Levels
Time frame: Day 29 and Day 181
Percentage of Participants Achieving Seroconversion to Pertussis Toxin as Measured by Mucosal IgA Levels
Time frame: Day 29 and Day 181

Results and safety

Results posted to the registry on 3 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BPZE1 10^7 CFU by VaxINator	15	15
BPZE1 10^9 CFU by VaxINator	15	15
BPZE1 10^9 CFU by Syringe	5	5
Placebo by VaxINator	15	15

Primary outcome: Number of Participants Experiencing Adverse Events of Special Interest (AESIs)

Time frame: Day 1 through Day 29. Count of participants. Unit: Participants

Measure	BPZE1 10^7 CFU by VaxINator n = 15	BPZE1 10^9 CFU by VaxINator n = 15	BPZE1 10^9 CFU by Syringe n = 5	Placebo by VaxINator n = 15
Value	0	0	0	0

Population analysed: The safety population consists of all participants who received the study vaccine and for whom any data on safety were available.

Primary outcome: Number of Participants Experiencing New Onset Chronic Medical Conditions (NOCMCs)

Time frame: Day 1 through Day 181. Count of participants. Unit: Participants

Measure	BPZE1 10^7 CFU by VaxINator n = 15	BPZE1 10^9 CFU by VaxINator n = 15	BPZE1 10^9 CFU by Syringe n = 5	Placebo by VaxINator n = 15
Value	1	0	0	0

Population analysed: The safety population consists of all participants who received the study vaccine and for whom any data on safety were available.

Primary outcome: Number of Participants Experiencing Serious Adverse Events (SAEs)

Time frame: Day 1 through Day 181. Count of participants. Unit: Participants

Measure	BPZE1 10^7 CFU by VaxINator n = 15	BPZE1 10^9 CFU by VaxINator n = 15	BPZE1 10^9 CFU by Syringe n = 5	Placebo by VaxINator n = 15
Value	0	0	0	0

Population analysed: The safety population consists of all participants who received the study vaccine and for whom any data on safety were available.

Primary outcome: Number of Participants Experiencing Solicited Local Reactogenicity Adverse Events (AEs)

Time frame: Day 1 through Day 15. Count of participants. Unit: Participants

Measure	BPZE1 10^7 CFU by VaxINator n = 15	BPZE1 10^9 CFU by VaxINator n = 15	BPZE1 10^9 CFU by Syringe n = 5	Placebo by VaxINator n = 15
Runny nose	6	7	2	5
Stuffy nose/congestion	8	8	2	6
Nasal pain/irritation	1	1	0	0
Epistaxis	1	0	0	1
Sneezing	4	5	1	3
Sinus pressure/pain	1	4	0	2
Sore/irritated throat	4	4	2	3
Cough	6	2	2	2

Population analysed: The safety population consists of all participants who received the study vaccine and for whom any data on safety were available.

28 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events were collected from the time of vaccination through approximately 6 months after vaccination. Solicited Adverse Events were collected from the time of each study vaccination through 14 days after study vaccination. Unsolicited AEs were collected from the time of study vaccination through approximately 28 days after study vaccination. New onset chronic medical conditions and adverse events of special interest were assessed through the follow-up period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BPZE1 10^7 CFU by VaxINator	0 of 15 (0%)	11 of 15 (73.3%)	0 of 15
BPZE1 10^9 CFU by VaxINator	0 of 15 (0%)	14 of 15 (93.3%)	0 of 15
BPZE1 10^9 CFU by Syringe	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Placebo by VaxINator	0 of 15 (0%)	13 of 15 (86.7%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pertussis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BPZE1 in people with Pertussis and Pertussis Immunisation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Adverse Events of Special Interest (AESIs) (time frame: Day 1 through Day 29). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03541499.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.