Clinical trial NCT02266628: Placebo- Controlled Study to Evaluate the Safety and Immunogenicity of the RSV-F Vaccine in Elderly Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus (RSV)
Lead sponsor: Novavax
Sponsor class: INDUSTRY
First posted: 2014-10-17
Enrollment: 1599
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment.
3. Able to comply with study requirements; including access to transportation for study visits.
4. 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 within 6 weeks of any prior influenza immunization.
3. Received any vaccine other than an inactivated influenza vaccine in the 4 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 disturbance of coagulation.
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).

Primary outcomes:
measure: Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen
timeFrame: Day 0 to Day 364
measure: Number and percentage of subjects with respiratory illness associated with RSV
timeFrame: Day 0 to Day 364
measure: Numbers and percentages of subjects with solicited local and systemic AEs.
timeFrame: Day 0 to Day 364
Secondary outcomes:
measure: Palivizumab competitive antibody responses based on antibody titers in competitive ELISA.
timeFrame: Day 0 to Day 182
measure: Neutralizing antibody titer to at least one prototypical RSV/A and one RSV/B virus strain.
timeFrame: Day 0 to Day 182
measure: Hemagglutination-inhibiting (HAI) antibody titers specific for the viruses in the 2014-15 vaccine at Day 28.
timeFrame: Day 0 to Day 28
Other outcomes:
Locations:
city: Redding
country: United States
facility: Nothern California Clinical Research
state: California
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Cleveland
country: United States
facility: Rapid Medical Research
state: Ohio
city: Nashville
country: United States
facility: Clinical Research Associates
state: Tennessee
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Seattle
country: United States
facility: Lisa Jackson
state: Washington
city: Wausau
country: United States
facility: Marshfield Clinical Research Foundation
state: Wisconsin
Study officials:
affiliation: Novavax, Inc.
name: Clinical Development
role: STUDY_DIRECTOR
References: