PertussisPhase 2NCT03942406

Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults

A Phase 2 study testing BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device in people with Pertussis and Whooping Cough, run by ILiAD Biotechnologies at 3 sites 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

This study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares a single (prime) BPZE1 dose or BPZE1 2-dose (prime + boost) to a single (prime) Boostrix or Boostrix prime + BPZE1 boost. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Pertussis, Whooping Cough
What is being tested?: BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 3 sitesUnited States
Study dates: 15 Jun 2019to 24 Jun 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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Is a male or nonpregnant female 18 to 50 years of age, inclusive, on Day 1 (primary vaccination).
Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
Female subjects must be nonpregnant and nonlactating and meet 1 of the following criteria:
Postmenopausal (defined as 12 consecutive months with no menses without an alternative medical cause or documented plasma follicle-stimulating hormone level in the postmenopausal range);
Surgically sterile (ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
NOTE: These procedures and laboratory test results must be confirmed by physical examination, or by subject recall of specific date and hospital/facility of procedure, or by medical documentation of said procedure.

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Is of childbearing potential (defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal), agrees to be heterosexually inactive from at least 21 days prior to enrollment and through 3 months after the boosting vaccination or agrees to consistently use any of the following methods of contraception from at least 21 days prior to enrollment and through 3 months after the boosting vaccination:
Condoms (male or female) with spermicide ii. Diaphragm with spermicide iii. Cervical cap with spermicide iv. Intrauterine device v. Oral or patch contraceptives vi. Norplant®, Depo-Provera®, or other FDA approved contraceptive method that is designed to protect against pregnancy.
NOTE: Periodic abstinence (eg, calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception.
Has a stable health status as assessed by the investigator, as established by physical examination, vital sign measurements, and medical history.
Has access to a consistent and reliable means of telephone contact, which may be in the home, workplace, or by personal mobile electronic device.
Is able to understand and comply with planned study procedures.
Lives a reasonable distance from the clinical site to be able to travel to and from the clinical site for follow-up visits and agrees to go to the clinical site for evaluation (or provide medical record access if evaluated elsewhere) in the event of an AE.
Agrees to stay in contact with the clinical site for the duration of the study, has no current plans to move from the study area, and provides updated contact information as necessary.

Who cannot join

History of being vaccinated in the past 5 years against pertussis.
Any significant past reaction to any component of Boostrix (at the discretion of the investigator).
Subject reported diagnosis of pertussis in the past 10 years (must be laboratory confirmed or physician diagnosed from medical records).
Vital signs by FDA toxicity scoring >1 (may be repeated once during the screening period to allow for inclusion and the most recent measurement taken at baseline).
Chronic illness being treated actively and with evidence of recent intervention for worsening or fluctuating symptoms (at the discretion of the investigator).
The subject has a history of active cancer (malignancy) in the last 10 years (exception is subjects with adequately treated non melanomatous skin carcinoma, who may participate in the study).

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Current use of any smoking products and unwillingness to refrain from the use of any smoking products from screening through 28 days after the boosting vaccination.
Use of narcotic drugs, evidenced by urine toxicology screen or a history of drug/alcohol abuse within the past 2 years.
Has donated blood or suffered from blood loss of more than 450 mL (1 unit of blood) within 60 days prior to screening or donated plasma within 14 days prior to screening.
Receipt of immunoglobulin, blood-derived products, systemic corticosteroids, or other immunosuppressant drugs within 90 days prior to Day 1.
Asthma, obstructive nasal canal, recurrent or acute sinusitis or other chronic respiratory problems inclusive of the diagnosis of any significant pulmonary disease.
History of nasal surgery or Bell's palsy.
Use of repeated nasal sprays, Neti pot, routine nasal washing within the past 1 month (more than 2 times per week). Subjects must agree to refrain from use of any of these modalities through Day 113.
A temporary exclusion to vaccinate if acute respiratory tract infection or rhinorrhea or temperature >100.4°F (no symptoms for 3 days prior to vaccination day). Subjects may be vaccinated if they stay within the vaccination window (screening [30 days] or at the time of the booster [10 days]).
NOTE: If a subject exceeds the screening window, they must be reconsented and screening must be reinitiated.
Use of corticosteroids in the respiratory tract (eg, nasal steroids, inhaled steroids) within 30 days prior to Day 1.
Receipt of a licensed vaccine within the last 30 days prior to Day 1 or planned vaccination during the active study conduct through Day 113. In the case of seasonal influenza, vaccination should not be withheld and is not contraindicated for subject participation. However, vaccination should be planned outside of a 30 day pre- and 30 day post vaccination window whenever possible.
Known hypersensitivity to any component of the study vaccines.
Participation in any other clinical trial for the testing of an unlicensed product during the previous 6 months or planned during the study conduct.
Inability to adhere to the protocol, including plans to move from the area.
Personal history or family (first degree) history of congenital or hereditary immunodeficiency.
Past or present infection with human immunodeficiency virus, hepatitis B, or hepatitis C by screening test.
Any autoimmune or immunodeficiency disease/condition (inherited or iatrogenic).
Any neurological disease or history of significant neurological disorder (eg, meningitis, seizures, multiple sclerosis, vasculitis, migraines, Guillain-Barré syndrome [genetic/congenital or acquired]).
Any medical condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might affect the safety of the individual, (eg, major depression or history of suicidal attempt).
Toxicity grading >1 for screening laboratory test results for kidney, hepatic, and hematologic values (may be repeated once during the screening period to allow for inclusion and the most recent measurement taken at baseline). See Table 13 2 for specifically designated parameters.
Body mass index <17 kg/m2 or >40 kg/m2.
Frequent contact with children less than 1 year of age (parent, childcare worker, nurse, etc.) or residence in the same household as persons with known immunodeficiency including persons on immunosuppressant therapy.
Study team member or first-degree relative of study team member.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Rapid medical Research Inc
Cleveland, Ohio, 44122
DM Clinical Research
Tomball, Texas, 77375
Advanced Clinical Research
West Jordan, Utah, 84088

Other trials in United States

About this study

Official title: Phase 2b Study of BPZE1 Intranasal Pertussis Vaccine in Adults to Assess Immunological Response and Safety Profile of 1-Dose (Prime) and 2-Doses (Prime+Boost) Schedule, Compared to a Boostrix™ Prime Dose With or Without a BPZE1 Boost Dose

Read the detailed description

Conditions: Pertussis, Whooping Cough
Being tested: BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device
Keywords: pertussis, Bordetella infection, Gram-negative bacterial infection, Respiratory tract infection, Whooping cough, Infection, Respiratory tract disease, Vaccine, Immunological factors, Physiological effects of drugs
Medical subject headings: Whooping Cough, Bordetella Infections, Gram-Negative Bacterial Infections, Respiratory Tract Infections, Infections, Respiratory Tract Diseases

What participants receive

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

BPZE1 pertussis vaccine and VaxINator(TM) Atomization DeviceCombination product
Live attenuated pertussis vaccine administered via the VaxINator(TM) atomization device

Study groups in NCT03942406
Study group	Role	What they receive
BPZE1 Intranasal Prime, BPZE1 Boost	Experimental	Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of intramuscular (I.M.) placebo. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device. Receives: Combination Product: BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device
BPZE1 Intranasal Prime, Placebo Boost	Experimental	Individual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of intramuscular (I.M.) placebo. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device. Receives: Combination Product: BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device
Boostrix IM Prime, BPZE1 Boost	Experimental	Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of intramuscular (I.M.) Boostrix (aP vaccine comparator). Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device. Receives: Combination Product: BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device
Boostrix IM Prime, Placebo Boost	Active comparator	Individual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of intramuscular (I.M.) Boostrix (aP vaccine comparator). Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device. Receives: Combination Product: BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device

What is being measured

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

Number of Participants With Nasal Mucosal Seroconversion (Immunoglobulin A [IgA])
Number of participants who achieve mucosal seroconversion (IgA) against at least 1 anti-pertussis antibody for whole cell extract (WCE), pertussis toxin (PT), filamentous hemagglutinin (FHA), or pertactin (PRN) on Day 29 or Day 113. Mucosal seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value was below the detection limits of the assay).
Measured: Days 29 and 113
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Number of participants with Solicited AEs (nasal/respiratory reactogenicity events) by Grade - Any Day Grade 1 through 3 and Grade 3. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) AEs.
Measured: Through 7 Days Following Day 1 Vaccination
Safety - Number of Participants With Local Solicited AEs
Number of participants with Solicited AEs (local reactogenicity events) by Grade - Any Day Grade 1 through 4 and Grade 3 and 4. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) AEs.
Measured: Through 7 Days Following Day 1 Vaccination
Safety - Number of Participants With Systemic Solicited AEs
Number of participants with Solicited AEs (systemic reactogenicity events) by Grade - Any Day Grade 1 through 3 and Grade 3. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) AEs.
Measured: Through 7 Days Following Day 1 Vaccination
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
Number of participants in the safety lead-in cohort with Grade 2 through 4 laboratory abnormalities: Serum Chemistry - Bilirubin, Creatinine, ALT, AST; WBC, Hemoglobin, Prothrombin time, Partial Thromboplastin Time. Grading of laboratory results is defined per protocol as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threatening) laboratory abnormalities (DHHS 2007).
Measured: Days 8 and 92

Secondary outcomes (13)

Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints
Number of participants who achieve seroconversion (serum IgG) against 1 or more pertussis antigens (pertussis toxin [PT], filamentous hemagglutinin [FHA], pertactin [PRN], or whole cell extract [WCE]) on Days 29, 85, 113, 169, and/or 254. Systemic seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value fell below the detection limits of the assay).
Measured: 9 months
Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints
Number of participants who achieve seroconversion (serum IgA) against 1 or more pertussis antigens (PT, FHA, PRN) on Days 29, 85, 113, 169, and/or 254. Systemic seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value fell below the detection limits of the assay).
Measured: 9 Months
Systemic Immunogenicity - Summary of Geometric Mean Fold Rises (GMFRs) of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point
Systemic Immunogenicity: Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Day 29 and Day 85 over baseline (Day 1)
Measured: Days 29 and 85
Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point
Systemic Immunogenicity: Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Days 113, 169, and 254 over baseline (Day 1)
Measured: Days 113, 169 and 254
Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints
Number of participants who achieve seroconversion against any pertussis specific antigen (PT, PRN, FHA, or WCE) in nasal secretions (S-IgA). Mucosal seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value was below the detection limits of the assay).
Measured: 9 months
Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point
Mucosal Immunogenicity: Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Day 29 and Day 78 over baseline (Day 1)
Measured: Days 29 and 78
Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point
Mucosal Immunogenicity: Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point - GMFRs on Day 113, Day 169, and Day 254 over baseline (Day 1)
Measured: Days 113, 169, 254
Colonization - Summary of Colonization for B. Pertussis Bacterial Culture From Nasal Sample by Timepoint
Number of participants with positive B. pertussis by bacterial culture of nasal sample on any of Days 92, 96, and 113 (colonization)
Measured: Days 92, 96, 113
Safety - Number of Participants With Unsolicited AEs
Number of participants with Unsolicited AEs collected Day 1 to Day 29 by Medical Dictionary for Regulatory Activities (MedDRA) classification.
Threshold is greater than or equal to 5% of participants.
Measured: Days 1 through 29
Safety - Number of Participants With Unsolicited AEs
Number of participants with Unsolicited AEs Day 85 through Day 113 by MedDRA classification.
Threshold is greater than or equal to 5% of participants.
Measured: Days 85 through 113
Safety - Number of Participants With Serious AEs
Number of participants with Serious AEs collected on Day 1 through Day 84 by MedDRA classification.
Measured: Days 1 to 84
Safety - Number of Participants With Serious AEs
Number of participants with Serious AEs collected on Day 85 through Day 113 by MedDRA classification.
Measured: Days 85 to 113
Safety - Number of Participants With Serious AEs
Number of participants with Serious AEs collected on Day 114 through Day 254 by MedDRA classification.
Measured: Days 114 to 254 (end of study)

Timeline

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

15 Jun 201924 Jun 2020

First posted8 May 2019
Study start15 Jun 2019
Primary completion14 Feb 2020
Study completion24 Jun 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.
Publications (9)Papers the sponsor has linked to this study.
Other trials for PertussisStudies of the same condition, open and under way.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03942406
Sponsor's protocol ID: IB-200P
Status last verified: May 2023
First submitted: 2 May 2019
Last updated: 27 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Publications

Althouse BM, Scarpino SV. Asymptomatic transmission and the resurgence of Bordetella pertussis. BMC Med. 2015 Jun 24;13:146. doi: 10.1186/s12916-015-0382-8.
PubMed 26103968
Feunou PF, Ismaili J, Debrie AS, Huot L, Hot D, Raze D, Lemoine Y, Locht C. Genetic stability of the live attenuated Bordetella pertussis vaccine candidate BPZE1. Vaccine. 2008 Oct 23;26(45):5722-7. doi: 10.1016/j.vaccine.2008.08.018. Epub 2008 Aug 30.
PubMed 18762220
Feunou PF, Mielcarek N, Locht C. Reciprocal interference of maternal and infant immunization in protection against pertussis. Vaccine. 2016 Feb 17;34(8):1062-9. doi: 10.1016/j.vaccine.2016.01.011. Epub 2016 Jan 15.
PubMed 26776471
Locht C, Papin JF, Lecher S, Debrie AS, Thalen M, Solovay K, Rubin K, Mielcarek N. Live Attenuated Pertussis Vaccine BPZE1 Protects Baboons Against Bordetella pertussis Disease and Infection. J Infect Dis. 2017 Jul 1;216(1):117-124. doi: 10.1093/infdis/jix254.
PubMed 28535276
Mielcarek N, Debrie AS, Raze D, Bertout J, Rouanet C, Younes AB, Creusy C, Engle J, Goldman WE, Locht C. Live attenuated B. pertussis as a single-dose nasal vaccine against whooping cough. PLoS Pathog. 2006 Jul;2(7):e65. doi: 10.1371/journal.ppat.0020065.
PubMed 16839199
Mielcarek N, Debrie AS, Mahieux S, Locht C. Dose response of attenuated Bordetella pertussis BPZE1-induced protection in mice. Clin Vaccine Immunol. 2010 Mar;17(3):317-24. doi: 10.1128/CVI.00322-09. Epub 2010 Jan 27.
PubMed 20107007
Skerry CM, Cassidy JP, English K, Feunou-Feunou P, Locht C, Mahon BP. A live attenuated Bordetella pertussis candidate vaccine does not cause disseminating infection in gamma interferon receptor knockout mice. Clin Vaccine Immunol. 2009 Sep;16(9):1344-51. doi: 10.1128/CVI.00082-09. Epub 2009 Jul 22.
PubMed 19625486
Warfel JM, Zimmerman LI, Merkel TJ. Acellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model. Proc Natl Acad Sci U S A. 2014 Jan 14;111(2):787-92. doi: 10.1073/pnas.1314688110. Epub 2013 Nov 25.
PubMed 24277828
Keech C, Miller VE, Rizzardi B, Hoyle C, Pryor MJ, Ferrand J, Solovay K, Thalen M, Noviello S, Goldstein P, Gorringe A, Cavell B, He Q, Barkoff AM, Rubin K, Locht C. Immunogenicity and safety of BPZE1, an intranasal live attenuated pertussis vaccine, versus tetanus-diphtheria-acellular pertussis vaccine: a randomised, double-blind, phase 2b trial. Lancet. 2023 Mar 11;401(10379):843-855. doi: 10.1016/S0140-6736(22)02644-7.
PubMed 36906345

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

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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 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2b Study of BPZE1 Intranasal Pertussis Vaccine in Adults to Assess Immunological Response and Safety Profile of 1-Dose (Prime) and 2-Doses (Prime+Boost) Schedule, Compared to a Boostrix™ Prime Dose With or Without a BPZE1 Boost Dose
ClinicalTrials.gov ID: NCT03942406
Acronym / sponsor ID: IB-200P
Conditions: Pertussis, Whooping Cough
Keywords: pertussis, Bordetella infection, Gram-negative bacterial infection, Respiratory tract infection, Whooping cough, Infection, Respiratory tract disease, Vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: ILiAD BiotechnologiesIndustry (pharma, biotech, devices)
Collaborators: PPD Development, LP
Study start: 15 Jun 2019 (actual)
Primary completion: 14 Feb 2020 (actual)
Study completion: 24 Jun 2020 (actual)
First posted: 8 May 2019 (actual)
Results: Posted 27 Jun 2023

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
BPZE1 Intranasal Prime, BPZE1 Boost	Experimental	Combination Product: BPZE1 pertussis vaccine and VaxINator(TM) Atomization DeviceIndividual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of intramuscular (I.M.) placebo. Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device.
BPZE1 Intranasal Prime, Placebo Boost	Experimental	Combination Product: BPZE1 pertussis vaccine and VaxINator(TM) Atomization DeviceIndividual will receive an intranasal dose of BPZE1 via the VaxINator atomization device and a dose of intramuscular (I.M.) placebo. Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device.
Boostrix IM Prime, BPZE1 Boost	Experimental	Combination Product: BPZE1 pertussis vaccine and VaxINator(TM) Atomization DeviceIndividual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of intramuscular (I.M.) Boostrix (aP vaccine comparator). Individuals will receive a boost dose of intranasal BPZE1 via the VaxINator™ atomization device.
Boostrix IM Prime, Placebo Boost	Active comparator	Combination Product: BPZE1 pertussis vaccine and VaxINator(TM) Atomization DeviceIndividual will receive an intranasal dose of placebo via the VaxINator atomization device and a dose of intramuscular (I.M.) Boostrix (aP vaccine comparator). Individuals will receive a boost dose of intranasal placebo via the VaxINator™ atomization device.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Is a male or nonpregnant female 18 to 50 years of age, inclusive, on Day 1 (primary vaccination).
Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
Female subjects must be nonpregnant and nonlactating and meet 1 of the following criteria:
NOTE: These procedures and laboratory test results must be confirmed by physical examination, or by subject recall of specific date and hospital/facility of procedure, or by medical documentation of said procedure.
NOTE: Periodic abstinence (eg, calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception.

Key exclusion criteria (29 listed)

History of being vaccinated in the past 5 years against pertussis.
Any significant past reaction to any component of Boostrix (at the discretion of the investigator).
Subject reported diagnosis of pertussis in the past 10 years (must be laboratory confirmed or physician diagnosed from medical records).
Vital signs by FDA toxicity scoring >1 (may be repeated once during the screening period to allow for inclusion and the most recent measurement taken at baseline).
Chronic illness being treated actively and with evidence of recent intervention for worsening or fluctuating symptoms (at the discretion of the investigator).

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
BPZE1 pertussis vaccine and VaxINator(TM) Atomization DeviceLive attenuated pertussis vaccine administered via the VaxINator(TM) atomization device	Combination product	BPZE1 Intranasal Prime, BPZE1 Boost, BPZE1 Intranasal Prime, Placebo Boost, Boostrix IM Prime, BPZE1 Boost, Boostrix IM Prime, Placebo Boost

Primary outcome

Number of Participants With Nasal Mucosal Seroconversion (Immunoglobulin A [IgA])
Time frame: Days 29 and 113
Number of participants who achieve mucosal seroconversion (IgA) against at least 1 anti-pertussis antibody for whole cell extract (WCE), pertussis toxin (PT), filamentous hemagglutinin (FHA), or pertactin (PRN) on Day 29 or Day 113. Mucosal seroconversion was defined as a 2-fold increase over the baseline value or a 4-fold increase over the minimal detection limit of the assay (whenever the baseline value was below the detection limits of the assay).
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Time frame: Through 7 Days Following Day 1 Vaccination
Number of participants with Solicited AEs (nasal/respiratory reactogenicity events) by Grade - Any Day Grade 1 through 3 and Grade 3. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) AEs.
Safety - Number of Participants With Local Solicited AEs
Time frame: Through 7 Days Following Day 1 Vaccination
Number of participants with Solicited AEs (local reactogenicity events) by Grade - Any Day Grade 1 through 4 and Grade 3 and 4. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) AEs.
Safety - Number of Participants With Systemic Solicited AEs
Time frame: Through 7 Days Following Day 1 Vaccination
Number of participants with Solicited AEs (systemic reactogenicity events) by Grade - Any Day Grade 1 through 3 and Grade 3. Grading of reactogenicity is defined per protocol as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) AEs.
Safety Lead-in Participants With Abnormal Laboratory Parameters (BPZE1 10^7 Safety Lead-In)
Time frame: Days 8 and 92
Number of participants in the safety lead-in cohort with Grade 2 through 4 laboratory abnormalities: Serum Chemistry - Bilirubin, Creatinine, ALT, AST; WBC, Hemoglobin, Prothrombin time, Partial Thromboplastin Time. Grading of laboratory results is defined per protocol as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threatening) laboratory abnormalities (DHHS 2007).

13 secondary outcomes

Systemic Immunogenicity - Summary of Systemic IgG Seroconversion Endpoints
Time frame: 9 months
Systemic Immunogenicity - Summary of Systemic IgA Seroconversion Endpoints
Time frame: 9 Months
Systemic Immunogenicity - Summary of Geometric Mean Fold Rises (GMFRs) of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point
Time frame: Days 29 and 85
Systemic Immunogenicity - Summary of GMFRs of Systemic IgG Against Whole Cell Extract by Vaccine Group and Time Point
Time frame: Days 113, 169 and 254
Mucosal Immunogenicity - Summary of Mucosal Absolute S-IgA/Total S-IgA Seroconversion Endpoints
Time frame: 9 months
Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point
Time frame: Days 29 and 78
Mucosal Immunogenicity - Summary of GMFRs of Mucosal Absolute S-IgA/Total S-IgA Against Whole Cell Extract by Vaccine Group and Time Point
Time frame: Days 113, 169, 254
Colonization - Summary of Colonization for B. Pertussis Bacterial Culture From Nasal Sample by Timepoint
Time frame: Days 92, 96, 113
Safety - Number of Participants With Unsolicited AEs
Time frame: Days 1 through 29
Safety - Number of Participants With Unsolicited AEs
Time frame: Days 85 through 113
Safety - Number of Participants With Serious AEs
Time frame: Days 1 to 84
Safety - Number of Participants With Serious AEs
Time frame: Days 85 to 113
Safety - Number of Participants With Serious AEs
Time frame: Days 114 to 254 (end of study)

Results and safety

Results posted to the registry on 27 Jun 2023, 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 Intranasal Prime, BPZE1 Boost	92	81
BPZE1 Intranasal Prime, Placebo Boost	92	85
Boostrix IM Prime, BPZE1 Boost	46	41
Boostrix IM Prime, Placebo Boost	50	40
BPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) Boost	8	6
BPZE1 (10^7) Intranasal Prime, Placebo Boost	8	7
Boostrix IM Prime, BPZE1 (10^7) Boost	4	4

Primary outcome: Number of Participants With Nasal Mucosal Seroconversion (Immunoglobulin A [IgA])

Time frame: Days 29 and 113. Count of participants. Unit: Participants

Measure	BPZE1 Intranasal Prime, BPZE1 Boost n = 84	BPZE1 Intranasal Prime, Placebo Boost n = 94	Boostrix IM Prime, BPZE1 Boost n = 42	Boostrix IM Prime, Placebo Boost n = 45
Value	79	89	38	42

Population analysed: 10\^9 Immunogenicity Analysis Set. The overall number of participants analyzed includes participants with nonmissing values. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study after second vaccination were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.

Primary outcome: Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)

Time frame: Through 7 Days Following Day 1 Vaccination. Number. Unit: participants

Measure	BPZE1 Intranasal Prime, BPZE1 Boost n = 87	BPZE1 Intranasal Prime, Placebo Boost n = 96	Boostrix IM Prime, BPZE1 Boost n = 46	Boostrix IM Prime, Placebo Boost n = 50
Runny Nose - Any Day Grade 1 through 3	25	41	17	16
Runny Nose - Any Day Grade 3	0	0	0	0
Stuffy Nose/Congestion - Any Day Grade 1 through 3	27	44	19	15
Stuffy Nose/Congestion - Any Day Grade 3	0	0	0	0
Nasal Pain/Irritation - Any Day Grade 1 through 3	10	13	7	7
Nasal Pain/Irritation - Any Day Grade 3	0	0	0	0
Epistaxis - Any Day Grade 1 through 3	1	5	2	1
Epistaxis - Any Day Grade 3	0	0	0	0

Population analysed: 10\^9 Safety Analysis Set. Note: Participants who were randomized to receive BPZE1 as the second vaccination (ie, revaccination/attenuated challenge) but who did not receive a second vaccination and continued in the study were placed into the BPZE1/Placebo or Boostrix/Placebo group according to first vaccine received.

Primary outcome: Safety - Number of Participants With Local Solicited AEs

Time frame: Through 7 Days Following Day 1 Vaccination. Number. Unit: participants

Measure	BPZE1 Intranasal Prime, BPZE1 Boost n = 87	BPZE1 Intranasal Prime, Placebo Boost n = 96	Boostrix IM Prime, BPZE1 Boost n = 46	Boostrix IM Prime, Placebo Boost n = 50
Pain - Any Day Grade 1 Through 4	8	7	22	27
Pain - Any Day Grade 3 and 4	0	0	0	0
Tenderness - Any Day Grade 1 Through 4	15	13	28	30
Tenderness - Any Day Grade 3 and 4	0	0	0	0
Erythema/Redness - Any Day Grade 1 Through 4	0	2	1	2
Erythema/Redness - Any Day Grade 3 and 4	0	0	0	0
Induration/Swelling - Any Day Grade 1 Through 4	0	0	4	2
Induration/Swelling - Any Day Grade 3 and 4	0	0	0	0

Primary outcome: Safety - Number of Participants With Systemic Solicited AEs

Time frame: Through 7 Days Following Day 1 Vaccination. Number. Unit: participants

Measure	BPZE1 Intranasal Prime, BPZE1 Boost n = 87	BPZE1 Intranasal Prime, Placebo Boost n = 96	Boostrix IM Prime, BPZE1 Boost n = 46	Boostrix IM Prime, Placebo Boost n = 50
Fever - Any Day Grade 1 through 3	0	1	0	0
Fever - Any Day Grade 3	0	1	0	0
Fatigue (Tiredness) - Any Day Grade 1 through 3	27	35	9	12
Fatigue (Tiredness) - Any Day Grade 3	0	1	0	0
Malaise (General Unwell Feeling) - Any Day Grade 1 through 3	13	25	6	8
Malaise (General Unwell Feeling) - Any Day Grade 3	0	1	0	0
Myalgia (Body Aches/Muscular Pain) - Any Day Grade 1 through 3	8	19	4	8
Myalgia (Body Aches/Muscular Pain) - Any Day Grade 3	0	1	0	0

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Unsolicited treatment-emergent adverse events (TEAEs) - Days 1 through 29 and Days 85 through 113; All-cause mortality and SAEs - Days 1 through 254 (end of study). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BPZE1 Intranasal Prime, BPZE1 Boost	1 of 87 (1.1%)	25 of 87 (28.7%)	0 of 87
BPZE1 Intranasal Prime, Placebo Boost	3 of 96 (3.1%)	26 of 96 (27.1%)	0 of 96
Boostrix IM Prime, BPZE1 Boost	1 of 46 (2.2%)	14 of 46 (30.4%)	0 of 46
Boostrix IM Prime, Placebo Boost	0 of 50 (0%)	12 of 50 (24%)	0 of 50
BPZE1 (10^7) Intranasal Prime, BPZE1 (10^7) Boost	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8
BPZE1 (10^7) Intranasal Prime, Placebo Boost	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Boostrix IM Prime, BPZE1 (10^7) Boost	0 of 4 (0%)	1 of 4 (25%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26103968Althouse BM, Scarpino SV. Asymptomatic transmission and the resurgence of Bordetella pertussis. BMC Med. 2015 Jun 24;13:146. doi: 10.1186/s12916-015-0382-8.
Background: PubMed 18762220Feunou PF, Ismaili J, Debrie AS, Huot L, Hot D, Raze D, Lemoine Y, Locht C. Genetic stability of the live attenuated Bordetella pertussis vaccine candidate BPZE1. Vaccine. 2008 Oct 23;26(45):5722-7. doi: 10.1016/j.vaccine.2008.08.018. Epub 2008 Aug 30.
Background: PubMed 26776471Feunou PF, Mielcarek N, Locht C. Reciprocal interference of maternal and infant immunization in protection against pertussis. Vaccine. 2016 Feb 17;34(8):1062-9. doi: 10.1016/j.vaccine.2016.01.011. Epub 2016 Jan 15.
Background: PubMed 28535276Locht C, Papin JF, Lecher S, Debrie AS, Thalen M, Solovay K, Rubin K, Mielcarek N. Live Attenuated Pertussis Vaccine BPZE1 Protects Baboons Against Bordetella pertussis Disease and Infection. J Infect Dis. 2017 Jul 1;216(1):117-124. doi: 10.1093/infdis/jix254.
Background: PubMed 16839199Mielcarek N, Debrie AS, Raze D, Bertout J, Rouanet C, Younes AB, Creusy C, Engle J, Goldman WE, Locht C. Live attenuated B. pertussis as a single-dose nasal vaccine against whooping cough. PLoS Pathog. 2006 Jul;2(7):e65. doi: 10.1371/journal.ppat.0020065.
Background: PubMed 20107007Mielcarek N, Debrie AS, Mahieux S, Locht C. Dose response of attenuated Bordetella pertussis BPZE1-induced protection in mice. Clin Vaccine Immunol. 2010 Mar;17(3):317-24. doi: 10.1128/CVI.00322-09. Epub 2010 Jan 27.
Background: PubMed 19625486Skerry CM, Cassidy JP, English K, Feunou-Feunou P, Locht C, Mahon BP. A live attenuated Bordetella pertussis candidate vaccine does not cause disseminating infection in gamma interferon receptor knockout mice. Clin Vaccine Immunol. 2009 Sep;16(9):1344-51. doi: 10.1128/CVI.00082-09. Epub 2009 Jul 22.
Background: PubMed 24277828Warfel JM, Zimmerman LI, Merkel TJ. Acellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model. Proc Natl Acad Sci U S A. 2014 Jan 14;111(2):787-92. doi: 10.1073/pnas.1314688110. Epub 2013 Nov 25.
Derived from this study: PubMed 36906345Keech C, Miller VE, Rizzardi B, Hoyle C, Pryor MJ, Ferrand J, Solovay K, Thalen M, Noviello S, Goldstein P, Gorringe A, Cavell B, He Q, Barkoff AM, Rubin K, Locht C. Immunogenicity and safety of BPZE1, an intranasal live attenuated pertussis vaccine, versus tetanus-diphtheria-acellular pertussis vaccine: a randomised, double-blind, phase 2b trial. Lancet. 2023 Mar 11;401(10379):843-855. doi: 10.1016/S0140-6736(22)02644-7.
DHHS, FDA, CBER (US). Guidance for industry: Toxicity grading for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trialsLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Mary B Manning, MD principal investigator

Rapid Medical Research Inc

Barbara Rizzardi, MD principal investigator

Advanced Clinical Research Services, LLC

Vicki Miller, MD principal investigator

DM Clinical Research

3 sites 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 pertussis vaccine and VaxINator(TM) Atomization Device in people with Pertussis and Whooping Cough, run by ILiAD Biotechnologies at 3 sites 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 14 inclusion and 29 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 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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. 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 27 Jun 2023). 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 With Nasal Mucosal Seroconversion (Immunoglobulin A [IgA]) (time frame: Days 29 and 113). The study lists 5 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 NCT03942406, which also lists 9 linked publications.

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 27 Jun 2023.