Respiratory Syncytial Virus InfectionsPhase 2NCT02247726
RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women.
A Phase 2 study testing RSV F vaccine (0.5mL injection) in people with Respiratory Syncytial Virus Infections, run by Novavax at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy third-trimester pregnant women and to assess the impact of maternal immunization on infant safety through one year of life. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- RSV F vaccine (0.5mL injection)
- 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
- 7 sitesUnited States
- Study dates
- Sep 2014to Jul 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women must meet all of the following criteria to be eligible to participate:
- ≥18 and ≤40 years-of-age.
- Singleton pregnancy of 33 to 35 weeks gestation on the day of planned vaccination.
- Good general maternal health as demonstrated by:
- Medical history (including history of adverse reactions to prior vaccines and allergies).
- Physical examination including at least vital signs (blood pressure, pulse, respirations, and oral temperature); weight; height; examination of the HEENT, cardiovascular, pulmonary, gastrointestinal (abdominal), musculoskeletal, lymphatic, and dermatologic organ systems; and documentation of fetal heart tones.
Show all 18Show fewer
- Clinical laboratory parameters including normal blood urea nitrogen, creatinine, ALT, AST, total bilirubin, alkaline phosphatase (ALP), hemoglobin, white blood count, and platelet count; and serologic exclusion of infection with hepatitis B (HBV) and C (HCV) viruses and HIV (as required). Note that normal ranges for vital signs and clinical laboratory parameters will be based on third trimester values published in Sheffield et al. [2013] and/or reference ranges for the third trimester of pregnancy of the central laboratory.
- Documentation that fulfills one of the following:
- Detailed (level II) second trimester or later anatomic ultrasound with no significant anatomic or growth abnormalities identified; OR
- Routine second trimester or later ultrasound with no significant anatomic or growth abnormalities identified, PLUS at least one of the following:
- Normal first trimester screening (based on ultrasound + serum analytes); or
- Normal cell-free fetal DNA; or
- Normal chorionic villus sampling (CVS) or amniocentesis; or
- Normal second trimester maternal serum quadruple screen; or
- Normal first and second trimester screening using integrated, sequential, or contingency approach; or
- Abnormal first or second trimester screening followed by normal CVS, amniocentesis, or cell-free fetal DNA.
- Able to understand, and both willing and physically able to comply with study procedures. This includes anticipation of reasonable geographic proximity to the study clinic and adequate transportation to comply with scheduled and unscheduled study follow-up visits.
- Able and willing to provide written informed consent for themselves and infant.
Who cannot join
- Pregnant women will be excluded if there is historical, physical examination, or laboratory evidence of any of the following criteria:
- Symptomatic cardiac or pulmonary disease requiring chronic drug therapy, including hypertension and asthma. Asthma will be exclusionary if the subject is receiving chronic systemic glucocorticoids at any dose or inhaled glucocorticoids at any dose >500µg per day of beclamethasone or fluticasone, or >800μg per day of budesonide.
- Pre-pregnancy body mass index (BMI) of ≥35 or <18.5.
- Hemoglobinopathy (including known sickle trait or thalassemias, even if asymptomatic) or blood dyscrasias.
- Hepatic or renal dysfunction.
- Established diagnosis of seizure disorder, regardless of therapy.
Show all 24Show fewer
- Auto-immune disease or known immunodeficiency syndrome.
- Endocrine disorders, including (but not limited to) hyperthyroidism, untreated hypothyroidism, and glucose intolerance (e.g., diabetes mellitus type 1 or 2) antedating pregnancy, or occurring during pregnancy and requiring interventions other than diet for control.
- History of major gynecologic or major abdominal surgery, including bariatric surgery.
- Known HIV, HBV, or HCV infection, as assessed by serologic tests conducted during the current pregnancy or as a procedure during the screening period of the study.
- Primary genital herpes simplex (HSV) infection during the current pregnancy.
- Current alcohol or drug abuse.
- Documentation that current pregnancy results from fertility treatments, rape, or incest.
- Documentation that the infant will be a ward of the state or be released for adoption.
- Neuro-psychiatric illness deemed likely to interfere with protocol compliance, safety reporting, or receipt of pre-natal care; or requiring treatment with psychotropic drugs.
- History/presence of deep venous thrombosis or thromboembolism, or the use of anticoagulants during pregnancy.
- Untreated red blood cell allo-immunization.
- Prior stillbirth or neonatal death, or multiple (≥3) spontaneous abortions.
- Prior preterm delivery ≤34 weeks gestation or having ongoing intervention (medical/surgical) in current pregnancy to prevent preterm birth.
- Greater than five (5) prior deliveries.
- Previous infant with a known genetic disorder or major congenital anomaly.
- Receipt of investigational drugs or immune globulins (with the exception of prophylactic anti-Rho D immune globulin) within six (6) months prior to the administration of the study vaccine.
- Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted except for the limit established in exclusion criterion #1.
- Any other physical, psychiatric or social condition which may, in the investigator's opinion, increase the risks of study participation to the maternal subject or the fetus/infant; or may lead to the collection of incomplete or inaccurate safety data.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Duke University
Durham, North Carolina, 27705
Baylor College of Medicine
Houston, Texas, 77030
Hutchinson Clinic, P.A.
Hutchinson, Kansas, 67502
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160
Advanced Specialty Research
Nampa, Idaho, 83687
Meridian Clinical Research
Norfolk, Nebraska, 68701
Magee- Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Phase II Randomized, Observer-Blind, Placebo-Controlled, Study to Evaluate the Safety and Immunogenicity of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum, in Healthy Third-trimester Pregnant Women and to Assess the Impact of Maternal Immunization on Infant Safety Through One Year of Life
The purpose of this study is to evaluate the safety and immunogenicity of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy third-trimester pregnant women and to assess the impact of maternal immunization on infant safety through one year of life.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- Saline Placebo (0.5mL injection), RSV F vaccine (0.5mL injection)
- Keywords
- RSV, Third Trimester, Maternal Immunization
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline Placebo (0.5mL injection)Drug
Also called 0.9% Sodium Choloride
RSV F vaccine (0.5mL injection)Drug
Also called RSV F Protein with Aluminum adjuvant
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Placebo comparator | Saline Placebo (0.5mL injection) Receives: Drug: Saline Placebo (0.5mL injection) |
| Treatment Group B | Experimental | RSV F vaccine with adjuvant (0.5mL injection) Receives: Drug: RSV F vaccine (0.5mL injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Counts and percentage of subjects with solicited injection site and systemic reactogenicity within seven days of vaccination.
In Maternal Subjects
Measured: Day 0 to Day D+180
Counts and percentage of subjects with unsolicited (local and systemic) adverse events (AE), unscheduled medically-attended adverse events (MAEs), and serious adverse events (SAEs) through delivery and six (6) months thereafter.
In Maternal Subjects
Measured: Day 0 to Day D+180
Clinical safety laboratory assessments of select serum chemistry and hematology parameters through delivery.
In Maternal Subjects
Measured: Screening to Day 14
Counts and percentage of subjects with post-immunization onset of specific complications of third-trimester pregnancy and delivery
In Maternal Subjects
Measured: Day 0 to Day 28 - 42
Counts and percentage of term healthy infants appropriate for gestational age.
In Infant subjects
Measured: Day 28 - 42
Neonatal SAEs (including congenital anomalies, respiratory failure, fever/infection, and neonatal death or other adverse events/complications that necessitate extended hospitalization).
In Infant Subjects
Measured: Birth to Day 365
Growth and development over one year
In Infant Subjects
Measured: Birth to Day Day 365
Counts and proportion of infants with unsolicited adverse events
In Infant Subjects
Measured: Birth to Day 365
Counts and proportions of infants with medically-attended RSV lower respiratory tract infection (LRTI), and age of onset of those infections.
In Infant Subjects
Measured: Birth to Day 365
Secondary outcomes (3)
Immunogenicity as assessed by serum IgG antibody titers specific fro the F-Protein antigen.
In Infant Subjects
Measured: Birth to Day 180
Serum antibody titers inhibiting binding of labeled palivizumab to RSV F protein.
In Infant Subjects
Measured: Birth to Day 180
Serum microneutralization (MN) titers against RSV/A and B.previously referenced, but based on GMT.
In Infant Subjects
Measured: Birth to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus InfectionsStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novavax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development, Study director, Novavax, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247726
- Sponsor's protocol ID
- RSV-M-203
- Status last verified
- May 2022
- First submitted
- 16 Sep 2014
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Munoz FM, Swamy GK, Hickman SP, Agrawal S, Piedra PA, Glenn GM, Patel N, August AM, Cho I, Fries L. Safety and Immunogenicity of a Respiratory Syncytial Virus Fusion (F) Protein Nanoparticle Vaccine in Healthy Third-Trimester Pregnant Women and Their Infants. J Infect Dis. 2019 Oct 22;220(11):1802-1815. doi: 10.1093/infdis/jiz390.
PubMed 31402384
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Observer-Blind, Placebo-Controlled, Study to Evaluate the Safety and Immunogenicity of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum, in Healthy Third-trimester Pregnant Women and to Assess the Impact of Maternal Immunization on Infant Safety Through One Year of Life
- ClinicalTrials.gov ID
- NCT02247726
- Acronym / sponsor ID
- RSV-M-203
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- RSV, Third Trimester, Maternal Immunization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NovavaxIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and immunogenicity of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy third-trimester pregnant women and to assess the impact of maternal immunization on infant safety through one year of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Placebo comparator | Drug: Saline Placebo (0.5mL injection)Saline Placebo (0.5mL injection) |
| Treatment Group B | Experimental | Drug: RSV F vaccine (0.5mL injection)RSV F vaccine with adjuvant (0.5mL injection) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- ≥18 and ≤40 years-of-age.
- Singleton pregnancy of 33 to 35 weeks gestation on the day of planned vaccination.
- Good general maternal health as demonstrated by:
- Documentation that fulfills one of the following:
- Able to understand, and both willing and physically able to comply with study procedures. This includes anticipation of reasonable geographic proximity to the study clinic and adequate transportation to comply with scheduled and unscheduled study follow-up visits.
Key exclusion criteria (24 listed)
- Pregnant women will be excluded if there is historical, physical examination, or laboratory evidence of any of the following criteria:
- Symptomatic cardiac or pulmonary disease requiring chronic drug therapy, including hypertension and asthma. Asthma will be exclusionary if the subject is receiving chronic systemic glucocorticoids at any dose or inhaled glucocorticoids at any dose >500µg per day of beclamethasone or fluticasone, or >800μg per day of budesonide.
- Pre-pregnancy body mass index (BMI) of ≥35 or <18.5.
- Hemoglobinopathy (including known sickle trait or thalassemias, even if asymptomatic) or blood dyscrasias.
- Hepatic or renal dysfunction.
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 |
|---|---|---|
| Saline Placebo (0.5mL injection)Also: 0.9% Sodium Choloride | Drug | Treatment Group A |
| RSV F vaccine (0.5mL injection)Also: RSV F Protein with Aluminum adjuvant | Drug | Treatment Group B |
Primary outcome
Counts and percentage of subjects with solicited injection site and systemic reactogenicity within seven days of vaccination.
Time frame: Day 0 to Day D+180
In Maternal Subjects
Counts and percentage of subjects with unsolicited (local and systemic) adverse events (AE), unscheduled medically-attended adverse events (MAEs), and serious adverse events (SAEs) through delivery and six (6) months thereafter.
Time frame: Day 0 to Day D+180
In Maternal Subjects
Clinical safety laboratory assessments of select serum chemistry and hematology parameters through delivery.
Time frame: Screening to Day 14
In Maternal Subjects
Counts and percentage of subjects with post-immunization onset of specific complications of third-trimester pregnancy and delivery
Time frame: Day 0 to Day 28 - 42
In Maternal Subjects
Counts and percentage of term healthy infants appropriate for gestational age.
Time frame: Day 28 - 42
In Infant subjects
Neonatal SAEs (including congenital anomalies, respiratory failure, fever/infection, and neonatal death or other adverse events/complications that necessitate extended hospitalization).
Time frame: Birth to Day 365
In Infant Subjects
Growth and development over one year
Time frame: Birth to Day Day 365
In Infant Subjects
Counts and proportion of infants with unsolicited adverse events
Time frame: Birth to Day 365
In Infant Subjects
Counts and proportions of infants with medically-attended RSV lower respiratory tract infection (LRTI), and age of onset of those infections.
Time frame: Birth to Day 365
In Infant Subjects
3 secondary outcomes
Immunogenicity as assessed by serum IgG antibody titers specific fro the F-Protein antigen.
Time frame: Birth to Day 180
Serum antibody titers inhibiting binding of labeled palivizumab to RSV F protein.
Time frame: Birth to Day 180
Serum microneutralization (MN) titers against RSV/A and B.previously referenced, but based on GMT.
Time frame: Birth to Day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Derived from this study: PubMed 31402384Munoz FM, Swamy GK, Hickman SP, Agrawal S, Piedra PA, Glenn GM, Patel N, August AM, Cho I, Fries L. Safety and Immunogenicity of a Respiratory Syncytial Virus Fusion (F) Protein Nanoparticle Vaccine in Healthy Third-Trimester Pregnant Women and Their Infants. J Infect Dis. 2019 Oct 22;220(11):1802-1815. doi: 10.1093/infdis/jiz390.
- Novavax, Inc.Link provided by the sponsor.
Related trials for Respiratory Syncytial Virus Infections
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization
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.
Clinical Development study director
Novavax, Inc.
7 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 RSV F vaccine (0.5mL injection) in people with Respiratory Syncytial Virus Infections, run by Novavax at 7 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 18 inclusion and 24 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 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Counts and percentage of subjects with solicited injection site and systemic reactogenicity within seven days of vaccination. (time frame: Day 0 to Day D+180). The study lists 9 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 NCT02247726, which also lists 1 linked publication.
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 May 2022.