Placebo- Controlled Study to Evaluate the Safety and Immunogenicity of the RSV-F Vaccine in Elderly Adults

Phase 2

Completed

• Conditions: Respiratory Syncytial Virus (RSV)
• Interventions: Biological: Saline Placebo; Biological: RSV-F Vaccine

• Registration Number: NCT02266628
• Lead Sponsor: Novavax

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-13
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-17
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Disposition First Submitted: 2017-05-30
• Disposition First Submitted QC: 2017-05-30
• Disposition First Posted: 2017-06-06
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1599

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.

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group B	Saline Placebo	Saline Placebo (0.5mL Injection)
Treatment Group A	RSV-F Vaccine	RSV-F vaccine (0.5mL Injection)

Primary Outcome Measures

Name	Time	Method
Number and percentage of subjects with respiratory illness associated with RSV	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.	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.
Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen	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)

Secondary Outcome Measures

Name	Time	Method
Palivizumab competitive antibody responses based on antibody titers in competitive ELISA.	Day 0 to Day 182	Summarized by geometric mean titer (GMT), GMR. GMFR, and SRR; as well as seroconversion rate (SCR).
Hemagglutination-inhibiting (HAI) antibody titers specific for the viruses in the 2014-15 vaccine at Day 28.	Day 0 to Day 28
Neutralizing antibody titer to at least one prototypical RSV/A and one RSV/B virus strain.	Day 0 to Day 182	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.

Trial Locations

Locations (10)

Lisa Jackson; 🇺🇸 Seattle, Washington, United States

Research Across America; 🇺🇸 Dallas, Texas, United States

Nothern California Clinical Research; 🇺🇸 Redding, California, United States

Clinical Research Associates; 🇺🇸 Nashville, Tennessee, United States

Advanced Clinical Research; 🇺🇸 West Jordan, Utah, United States

Marshfield Clinical Research Foundation; 🇺🇸 Wausau, Wisconsin, United States

Johnson County Clin-Trials; 🇺🇸 Lenexa, Kansas, United States

Clinical Research Atlanta; 🇺🇸 Stockbridge, Georgia, United States

Rapid Medical Research; 🇺🇸 Cleveland, Ohio, United States

Clinical Trials of Texas; 🇺🇸 San Antonio, Texas, United States