Respiratory Syncytial Virus (RSV)Phase 2NCT02266628
Placebo- Controlled Study to Evaluate the Safety and Immunogenicity of the RSV-F Vaccine in Elderly Adults
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
The purpose of this study is to evaluate the safety and immunogenicity of the RSV- F Vaccine in elderly subjects, as well as rate the incidence of medically- attended RSV disease in vaccine and placebo recipients. 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
- 1,599 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2014to Mar 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 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 serious adverse events (SAEs) within two months, and
- Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the investigator.
- 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.
- Access to inbound and outbound telephone communication with caregivers and study staff.
Who cannot join
- Participation in research involving investigational product (drug / biologic / device) within 45 days before the planned date of the Day 0 vaccination.
- History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
- Received any vaccine other than an inactivated influenza vaccine in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time.
- 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.
- 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
Lisa Jackson
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 Respiratory Syncytial Virus (RSV) F Vaccine in Healthy Elderly Subjects and to Estimate the Incidence Rate of Medically-attended RSV Disease in Vaccine and Placebo Recipients
The purpose of this study is to evaluate the safety and immunogenicity of the RSV- F Vaccine in elderly subjects, as well as rate the incidence of medically- attended RSV disease in vaccine and placebo recipients.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- RSV-F Vaccine, Saline Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV-F VaccineBiological
Saline 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 | Saline Placebo (0.5mL Injection) Receives: Biological: Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen
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 concentrations as EU (GMEU)
- Geometric mean ratio (GMR)
- Geometric mean fold-rise( GMFR)
- Seroresponse rate (SRR)
Measured: Day 0 to Day 364
Number and percentage of subjects with respiratory illness associated with RSV
Defined by any one of rhinorrhea, nasal congestion, pharyngitis, cough, wheezing (or increase in baseline wheezing), sputum production (or increase in the change in nature of baseline sputum production), or new (or worsening) shortness of breath; plus RT-PRC-confirmed RSV infection documented within three days of symptom onset.
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, including adverse changes in clinical laboratory parameters over 56 days post injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year.
Measured: Day 0 to Day 364
Secondary outcomes (3)
Palivizumab competitive antibody responses based on antibody titers in competitive ELISA.
Summarized by geometric mean titer (GMT), GMR. GMFR, and SRR; as well as seroconversion rate (SCR).
Measured: Day 0 to Day 182
Neutralizing antibody titer to at least one prototypical RSV/A and one RSV/B virus strain.
Analyzed by GMT,GMR, SCR, and SRR. Neutralizing antibody assays, because of their time intensive nature, will be performed at a selected subset of time-points.
Measured: Day 0 to Day 182
Hemagglutination-inhibiting (HAI) antibody titers specific for the viruses in the 2014-15 vaccine at Day 28.
Measured: Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2016
- Study completionMar 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
- 1,599 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
- NCT02266628
- Sponsor's protocol ID
- RSV-E-201
- Status last verified
- May 2022
- First submitted
- 13 Oct 2014
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 Respiratory Syncytial Virus (RSV) F Vaccine in Healthy Elderly Subjects and to Estimate the Incidence Rate of Medically-attended RSV Disease in Vaccine and Placebo Recipients
- ClinicalTrials.gov ID
- NCT02266628
- Acronym / sponsor ID
- RSV-E-201
- Conditions
- Respiratory Syncytial Virus (RSV)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,599 participants (actual)
- Lead sponsor
- NovavaxIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Oct 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 the RSV- F Vaccine in elderly subjects, as well as rate the incidence of medically- attended RSV disease in vaccine and placebo recipients.
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: Saline PlaceboSaline 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 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.
- Access to inbound and outbound telephone communication with caregivers and study staff.
Key exclusion criteria (10 listed)
- Participation in research involving investigational product (drug / biologic / device) within 45 days before the planned date of the Day 0 vaccination.
- History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
- Received any vaccine other than an inactivated influenza vaccine in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time.
- 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 |
| Saline Placebo | Biological | Treatment Group B |
Primary outcome
Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen
Time frame: Day 0 to Day 364
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 concentrations as EU (GMEU) * Geometric mean ratio (GMR) * Geometric mean fold-rise( GMFR) * Seroresponse rate (SRR)
Number and percentage of subjects with respiratory illness associated with RSV
Time frame: Day 0 to Day 364
Defined by any one of rhinorrhea, nasal congestion, pharyngitis, cough, wheezing (or increase in baseline wheezing), sputum production (or increase in the change in nature of baseline sputum production), or new (or worsening) shortness of breath; plus RT-PRC-confirmed RSV infection documented within three days of symptom onset.
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, including adverse changes in clinical laboratory parameters over 56 days post injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year.
3 secondary outcomes
Palivizumab competitive antibody responses based on antibody titers in competitive ELISA.
Time frame: Day 0 to Day 182
Neutralizing antibody titer to at least one prototypical RSV/A and one RSV/B virus strain.
Time frame: Day 0 to Day 182
Hemagglutination-inhibiting (HAI) antibody titers specific for the viruses in the 2014-15 vaccine at Day 28.
Time frame: Day 0 to Day 28
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?
Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen (time frame: Day 0 to Day 364). The study lists 3 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.