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A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults

Sponsor
Novavax (Industry)
Overall Status
Completed
CT.gov ID
NCT02608502
Collaborator
(none)
11,850
Enrollment
60
Locations
2
Arms
13
Actual Duration (Months)
197.5
Patients Per Site
15.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: RSV-F Vaccine
  • Biological: Phosphate Buffer Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
11850 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults
Actual Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group A

RSV-F Vaccine (0.5mL Injection)

Biological: RSV-F Vaccine
Placebo Comparator: Treatment Group B

Phosphate Buffer Placebo (0.5mL Injection)

Biological: Phosphate Buffer Placebo

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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)

  3. 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)

  4. 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)

  5. 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.

  6. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. 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.

  1. Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment.

  2. Able to comply with study requirements; including access to transportation for study visits.

  3. Access to inbound and outbound telephone communication with caregivers and study staff.

Exclusion Criteria:

  1. Participation in research involving investigational product (drug / biologic / device) within 45 days before the planned date of the Day 0 vaccination.

  2. History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization.

  3. 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.

  4. Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.

  5. 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.

  6. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.

  7. 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).

  8. 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.

  9. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.

  10. 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site US062 Birmingham Alabama United States 35216
2 Research Site US061 Mobile Alabama United States 36608
3 Research Site US046 Mesa Arizona United States 85206
4 Research Site US054 Phoenix Arizona United States 85050
5 Research Site US048 Tempe Arizona United States 85283
6 Research Site US005 Anaheim California United States 92801
7 Research Site US028 Redding California United States 96001
8 Research Site US064 San Diego California United States 92117
9 Research Site US045 Savannah Georgia United States 31406
10 Research Site US013 Stockbridge Georgia United States 30281
11 Research Site US012 Boise Idaho United States 83642
12 Research Site US069 Chicago Illinois United States 60654
13 Research Site US065 Peoria Illinois United States 61614
14 Research Site US003 Lenexa Kansas United States 66219
15 Research Site US052 Newton Kansas United States 67114
16 Research Site US058 Wichita Kansas United States 67207
17 Research Site US080 Lexington Kentucky United States 40509
18 Research Site US068 Metairie Louisiana United States 70002
19 Research Site US039 Metairie Louisiana United States 70006
20 Research Site US055 Methuen Massachusetts United States 01844
21 Research Site US072 Edina Minnesota United States 55435
22 Research Site US051 Kansas City Missouri United States 64114
23 Research Site US076 Saint Louis Missouri United States 63141
24 Research Site US025 Norfolk Nebraska United States 68701
25 Research Site US018 Omaha Nebraska United States 68134
26 Research Site US057 Las Vegas Nevada United States 89119
27 Research Site US059 Newington New Hampshire United States 03801
28 Research Site US066 Binghamton New York United States 13901
29 Research Site US017 Endwell New York United States 13760
30 Research Site US049 Rochester New York United States 14609
31 Research Site US078 Cary North Carolina United States 27518
32 Research Site US020 Durham North Carolina United States 27710
33 Research Site US071 Wilmington North Carolina United States 28401
34 Research Site US063 Winston-Salem North Carolina United States 27103
35 Research Site US081 Cincinnati Ohio United States 45219
36 Research Site US085 Cincinnati Ohio United States 45227
37 Research Site US030 Cleveland Ohio United States 44122
38 Research Site US053 Oklahoma City Oklahoma United States 73112
39 Research Site US044 Warwick Rhode Island United States 02886
40 Research Site US070 Charleston South Carolina United States 29407
41 Research Site US056 Mount Pleasant South Carolina United States 29464
42 Research Site US079 Mount Pleasant South Carolina United States 29464
43 Research Site US050 Dakota Dunes South Dakota United States 57049
44 Research Site US074 Bristol Tennessee United States 37620
45 Research Site US077 Knoxville Tennessee United States 37920
46 Research Site US029 Nashville Tennessee United States 37203
47 Research Site US047 Austin Texas United States 78705
48 Research Site US010 Dallas Texas United States 75234
49 Research Site US083 Fort Worth Texas United States 76104
50 Research Site US060 Fort Worth Texas United States 76135
51 Research Site US019 Houston Texas United States 77030
52 Research Site US084 San Angelo Texas United States 76904
53 Research Site US073 Tomball Texas United States 77375
54 Research Site US082 Salt Lake City Utah United States 84109
55 Research Site US075 Salt Lake City Utah United States 84121
56 Research Site US008 Salt Lake City Utah United States 84124
57 Research Site US027 West Jordan Utah United States 84088
58 Research Site US067 Norfolk Virginia United States 23507
59 Research Site US026 Seattle Washington United States 98101
60 Research Site US024 Marshfield Wisconsin United States 54449

Sponsors and Collaborators

  • Novavax

Investigators

  • Study Director: Clinical Development, Novavax, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novavax
ClinicalTrials.gov Identifier:
NCT02608502
Other Study ID Numbers:
  • RSV-E-301
First Posted:
Nov 18, 2015
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022

Study Results

No Results Posted as of Jul 19, 2022