A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults
- Conditions
- Respiratory Syncytial Virus (RSV)
- Interventions
- Biological: RSV-F VaccineBiological: Phosphate Buffer Placebo
- Registration Number
- NCT02608502
- Lead Sponsor
- Novavax
- Brief Summary
The purpose of this study is to demonstrate the efficacy of the RSV F vaccine at a dose of 135µg via intramuscular (IM) injection in the prevention of moderate-severe RSV-associated lower respiratory tract disease (RSV-LRTD) in older adults ≥ 60 years of age.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11850
-
Males and females ≥60 years of age who are ambulatory and live in the community, or in assisted-living or long-term care residential facilities that 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 one month of the planned vaccination on Day 0, and
- Absence of known, current, and life-limiting diagnoses which, in the opinion of the investigator, render survival to completion of the protocol 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.
-
Access to inbound and outbound telephone communication with caregivers and study staff.
- 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 (GBS) within 6 weeks of any prior influenza immunization.
- Receipt of any vaccine other than an IIV in the 4 weeks preceding the study vaccination or a pneumococcal vaccine in the 2 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.
- 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 uncontrolled disorder 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group A RSV-F Vaccine RSV-F Vaccine (0.5mL Injection) Treatment Group B Phosphate Buffer Placebo Phosphate Buffer Placebo (0.5mL Injection)
- Primary Outcome Measures
Name Time Method Numbers and percentages of subjects with moderate-severe RSV-LRTD Day 0 to Day 182 Defined by the presence of at least three (3) of: cough, wheezing (or worsening in baseline wheezing), new sputum production (or increase in baseline sputum production), new (or worsening) shortness of breath, and observed tachypnea (≥20 breaths per minute); plus RT-PCR-confirmed RSV infection documented within five days of symptom onset.
Numbers and percentages of subjects with solicited local and systemic AEs Day 0 to Day 364 Defined as solicited local and systemic AEs over the 7 days post-injection; all adverse events, solicited and unsolicited over 56 days after dosing; and MAEs, SAEs, and SNMCs over one year post dosing.
- Secondary Outcome Measures
Name Time Method Number and percentage of subjects with RSV-ARD and/or RSV-LRTD Day 0 to Day 364 Summarized by treatment group and by age strata and in strata defined by comorbidities and type of community housing.
Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA Day 0 to Day 364 Summarized by:
* Geometric Mean Concentrations as EU (GMEU)
* Geometric Mean Fold Rise (GMFR)Numbers and percentages of subjects with RSV-Acute Respiratory Disease (RSV-ARD) Day 0 to Day 182 Defined by the presence of at least one (1) of: rhinorrhea, nasal congestion, pharyngitis, cough, wheezing (or worsening in baseline wheezing), new sputum production (or increase in baseline sputum production), new (or worsening) shortness of breath; plus RT-PCR-confirmed RSV infection documented within five days of symptom onset.
RSV F protein antibody expressed as ELISA Units (EU). Day 0 to Day 364 Summarized by:
* Geometric Mean Concentrations as EU (GMEU)
* Geometric Mean Ratio (GMR)
* Seroresponse Rate (SRR)Hemagglutination-inhibiting (HAI) antibody titers specific for the viruses in the 2015-16 IIV at Day 28 in the subset of subjects in each treatment group that receive IIV concurrently with study test article. Day 0 to Day 28 Neutralizing antibody titer to at least one RSV/A and one RSV/B virus strain Day 0 to Day 28 Summarized by:
* Geometric Mean Titer (GMT)
* Geometric Mean Ratio (GMR)
Trial Locations
- Locations (60)
Research Site US062
🇺🇸Birmingham, Alabama, United States
Research Site US061
🇺🇸Mobile, Alabama, United States
Research Site US046
🇺🇸Mesa, Arizona, United States
Research Site US054
🇺🇸Phoenix, Arizona, United States
Research Site US048
🇺🇸Tempe, Arizona, United States
Research Site US005
🇺🇸Anaheim, California, United States
Research Site US028
🇺🇸Redding, California, United States
Research Site US012
🇺🇸Boise, Idaho, United States
Research Site US013
🇺🇸Stockbridge, Georgia, United States
Research Site US045
🇺🇸Savannah, Georgia, United States
Research Site US065
🇺🇸Peoria, Illinois, United States
Research Site US003
🇺🇸Lenexa, Kansas, United States
Research Site US058
🇺🇸Wichita, Kansas, United States
Research Site US051
🇺🇸Kansas City, Missouri, United States
Research Site US055
🇺🇸Methuen, Massachusetts, United States
Research Site US080
🇺🇸Lexington, Kentucky, United States
Research Site US068
🇺🇸Metairie, Louisiana, United States
Research Site US039
🇺🇸Metairie, Louisiana, United States
Research Site US072
🇺🇸Edina, Minnesota, United States
Research Site US025
🇺🇸Norfolk, Nebraska, United States
Research Site US076
🇺🇸Saint Louis, Missouri, United States
Research Site US018
🇺🇸Omaha, Nebraska, United States
Research Site US059
🇺🇸Newington, New Hampshire, United States
Research Site US066
🇺🇸Binghamton, New York, United States
Research Site US078
🇺🇸Cary, North Carolina, United States
Research Site US049
🇺🇸Rochester, New York, United States
Research Site US017
🇺🇸Endwell, New York, United States
Research Site US020
🇺🇸Durham, North Carolina, United States
Research Site US071
🇺🇸Wilmington, North Carolina, United States
Research Site US063
🇺🇸Winston-Salem, North Carolina, United States
Research Site US070
🇺🇸Charleston, South Carolina, United States
Research Site US056
🇺🇸Mount Pleasant, South Carolina, United States
Research Site US044
🇺🇸Warwick, Rhode Island, United States
Research Site US077
🇺🇸Knoxville, Tennessee, United States
Research Site US074
🇺🇸Bristol, Tennessee, United States
Research Site US050
🇺🇸Dakota Dunes, South Dakota, United States
Research Site US047
🇺🇸Austin, Texas, United States
Research Site US083
🇺🇸Fort Worth, Texas, United States
Research Site US060
🇺🇸Fort Worth, Texas, United States
Research Site US010
🇺🇸Dallas, Texas, United States
Research Site US084
🇺🇸San Angelo, Texas, United States
Research Site US073
🇺🇸Tomball, Texas, United States
Research Site US082
🇺🇸Salt Lake City, Utah, United States
Research Site US075
🇺🇸Salt Lake City, Utah, United States
Research Site US008
🇺🇸Salt Lake City, Utah, United States
Research Site US067
🇺🇸Norfolk, Virginia, United States
Research Site US024
🇺🇸Marshfield, Wisconsin, United States
Research Site US069
🇺🇸Chicago, Illinois, United States
Research Site US030
🇺🇸Cleveland, Ohio, United States
Research Site US019
🇺🇸Houston, Texas, United States
Research Site US026
🇺🇸Seattle, Washington, United States
Research Site US057
🇺🇸Las Vegas, Nevada, United States
Research Site US064
🇺🇸San Diego, California, United States
Research Site US081
🇺🇸Cincinnati, Ohio, United States
Research Site US085
🇺🇸Cincinnati, Ohio, United States
Research Site US027
🇺🇸West Jordan, Utah, United States
Research Site US053
🇺🇸Oklahoma City, Oklahoma, United States
Research Site US029
🇺🇸Nashville, Tennessee, United States
Research Site US079
🇺🇸Mount Pleasant, South Carolina, United States
Research Site US052
🇺🇸Newton, Kansas, United States