Respiratory Syncytial Virus (RSV)Phase 2NCT02593071
Safety and Immunogenicity of the RSV-F Vaccine in Older Adults Previously Treated With the Same Vaccine or Placebo in the Prior Year.
A Phase 2 study testing RSV-F Vaccine in people with Respiratory Syncytial Virus (RSV), run by Novavax at 10 sites in United States.
Trial summary
This study will enroll subjects who received the RSV F vaccine or placebo in the earlier study (RSV-E-201, Year 1) and re-randomize them to receive either vaccine or placebo in a second season. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- What is being tested?
- RSV-F Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,330 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2015to Nov 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females ≥60 years of age who are veterans of the RSV-E-201 clinical trial and who are ambulatory and live in the community or in residential facilities which provide minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living. Subjects may have one or more chronic medical diagnoses, but should be clinically stable as assessed by:
- Absence of changes in medical therapy within one month due to treatment failure or toxicity,
- Absence of medical events qualifying as SAEs within two months, and
- Absence of known, current, life-limiting diagnoses that, in the opinion of the investigator, render survival to trial completion unlikely.
- Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment.
- Able to comply with study requirements, including access to transportation for study visits. The investigator may use his/her discretion to assess potential ability and willingness to comply based on performance in the prior trial, RSV-E-201.
- Access to inbound and outbound communication by telephone with caregivers and study staff.
Who cannot join
- Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination, with the exception of participation in the preceding study RSV-E-201.
- History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization, or withdrawal from the preceding RSV-E-201 clinical trial due to an adverse event deemed test article-related or at the advice of the investigator.
- Receipt of any vaccine other than IIV in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time unless administered in the preceding study, RSV-E-201.
- Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
- 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.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
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- Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature ≥38.0°C on the planned day of vaccine administration).
- Known disturbance of coagulation. Potential subjects receiving aspirin, clopidogrel, prasugrel, dipyridamole, dabigatran, apixaban, rivaroxaban or warfarin under good control for cardiovascular prophylaxis or prophylaxis of thromboembolic disease or stroke in the setting of atrial fibrillation will NOT be excluded.
- Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
- Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic, cognitive, or psychiatric conditions deemed likely to impair the quality of study compliance or safety reporting).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Rapid Medical Research
Cleveland, Ohio, 44122
Research Across America
Dallas, Texas, 75234
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Clinical Research Associates
Nashville, Tennessee, 37203
Nothern California Clinical Research
Redding, California, 96001
Clinical Trials of Texas
San Antonio, Texas, 78229
Group Health Research Institute
Seattle, Washington, 98101
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Marshfield Clinical Research Foundation
Wausau, Wisconsin, 54401
Advanced Clinical Research
West Jordan, Utah, 84088
About this study
Official title: A Phase II Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) Recombinant F Nanoparticle Vaccine in Healthy Older Adult Subjects Previously Treated With the Same Vaccine, or Placebo, in the Prior Year; and to Estimate the Incidence Rate of RSV Disease and Vaccine Efficacy in Subjects Based on Their RSV F Vaccine Experience Over Two Consecutive Years.
This study will enroll subjects who received the RSV F vaccine or placebo in the earlier study (RSV-E-201, Year 1) and re-randomize them to receive either vaccine or placebo in a second season. This design will permit evaluation of the safety and immunogenicity of revaccination in a second RSV season, and the safety and immunogenicity of revaccination over two years.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- RSV-F Vaccine, Phosphate Buffer Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV-F VaccineBiological
Phosphate Buffer PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Experimental | RSV-F Vaccine ( 0.5mL Injection) Receives: Biological: RSV-F Vaccine |
| Treatment Group B | Placebo comparator | Phosphate Buffer Placebo (0.5mL Injection) Receives: Biological: Phosphate Buffer Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen.
Derived/calculated endpoints based on these data will include:
- Geometric mean concentration as EU (GMEU)
- Geometric mean ratio (GMR)
- Seroresponse rate (SRR)
- Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)
Measured: Day 0 to Day 364
Numbers and percentages of subjects with solicited local and systemic AEs
Solicited local and systemic AEs over the seven days post-injection; and all adverse events, solicited and unsolicited, over 56 days post-dosing (Year 2). In addition, MAEs, SAEs, and SNMCs will be collected for 1 year (approximately 364 days) post-dosing
Measured: Day 0 to Day 364
Secondary outcomes (2)
Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA
Summarized by:
- Geometric mean concentrations (GMC)
- Geometric mean ratio (GMR)
- Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)
Measured: Day 0 to Day 182
Neutralizing antibody titer to at least one RSV/A and one RSV/B strain.
Summarized by:
- Geometric mean titer (GMT)
- Geometric mean ratio (GMR)
- Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)
Measured: Day 0 to Day 182
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies 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
- 1,330 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
- NCT02593071
- Sponsor's protocol ID
- RSV-E-202
- Status last verified
- May 2022
- First submitted
- 22 Oct 2015
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
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 Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) Recombinant F Nanoparticle Vaccine in Healthy Older Adult Subjects Previously Treated With the Same Vaccine, or Placebo, in the Prior Year; and to Estimate the Incidence Rate of RSV Disease and Vaccine Efficacy in Subjects Based on Their RSV F Vaccine Experience Over Two Consecutive Years.
- ClinicalTrials.gov ID
- NCT02593071
- Acronym / sponsor ID
- RSV-E-202
- Conditions
- Respiratory Syncytial Virus (RSV)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,330 participants (actual)
- Lead sponsor
- NovavaxIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 Oct 2015 (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.
This study will enroll subjects who received the RSV F vaccine or placebo in the earlier study (RSV-E-201, Year 1) and re-randomize them to receive either vaccine or placebo in a second season. This design will permit evaluation of the safety and immunogenicity of revaccination in a second RSV season, and the safety and immunogenicity of revaccination over two years.
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 | Experimental | Biological: RSV-F VaccineRSV-F Vaccine ( 0.5mL Injection) |
| Treatment Group B | Placebo comparator | Biological: Phosphate Buffer PlaceboPhosphate Buffer Placebo (0.5mL Injection) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females ≥60 years of age who are veterans of the RSV-E-201 clinical trial and who are ambulatory and live in the community or in residential facilities which provide minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living. Subjects may have one or more chronic medical diagnoses, but should be clinically stable as assessed by:
- Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment.
- Able to comply with study requirements, including access to transportation for study visits. The investigator may use his/her discretion to assess potential ability and willingness to comply based on performance in the prior trial, RSV-E-201.
- Access to inbound and outbound communication by telephone with caregivers and study staff.
Key exclusion criteria (10 listed)
- Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination, with the exception of participation in the preceding study RSV-E-201.
- History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization, or withdrawal from the preceding RSV-E-201 clinical trial due to an adverse event deemed test article-related or at the advice of the investigator.
- Receipt of any vaccine other than IIV in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time unless administered in the preceding study, RSV-E-201.
- Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
- 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.
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 |
|---|---|---|
| RSV-F Vaccine | Biological | Treatment Group A |
| Phosphate Buffer Placebo | Biological | Treatment Group B |
Primary outcome
Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen.
Time frame: Day 0 to Day 364
Derived/calculated endpoints based on these data will include: * Geometric mean concentration as EU (GMEU) * Geometric mean ratio (GMR) * Seroresponse rate (SRR) * Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)
Numbers and percentages of subjects with solicited local and systemic AEs
Time frame: Day 0 to Day 364
Solicited local and systemic AEs over the seven days post-injection; and all adverse events, solicited and unsolicited, over 56 days post-dosing (Year 2). In addition, MAEs, SAEs, and SNMCs will be collected for 1 year (approximately 364 days) post-dosing
2 secondary outcomes
Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA
Time frame: Day 0 to Day 182
Neutralizing antibody titer to at least one RSV/A and one RSV/B strain.
Time frame: Day 0 to Day 182
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.
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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.
Clinical Development study director
Novavax, Inc.
10 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 in people with Respiratory Syncytial Virus (RSV), run by Novavax at 10 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 7 inclusion and 10 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 10 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?
Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen. (time frame: Day 0 to Day 364). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.