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

NCT02266628 | Completed Phase 2 FDA Drug

• 1 other identifier: RSV-E-201
• Study Type: interventional
• Target: 1,599
• Locations: 1 country
• Sites: 10

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.

Conditions

Respiratory Syncytial Virus (RSV)

Outcome Measures

Primary Outcomes (3)

• 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)

  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.

  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.

  Day 0 to Day 364

Secondary Outcomes (3)

• Palivizumab competitive antibody responses based on antibody titers in competitive ELISA.

  Day 0 to Day 182

• Neutralizing antibody titer to at least one prototypical RSV/A and one RSV/B virus strain.

  Day 0 to Day 182

• Hemagglutination-inhibiting (HAI) antibody titers specific for the viruses in the 2014-15 vaccine at Day 28.

  Day 0 to Day 28

Study Arms (2)

Treatment Group A

EXPERIMENTAL

RSV-F vaccine (0.5mL Injection)

Biological: RSV-F Vaccine

Treatment Group B

PLACEBO COMPARATOR

Saline Placebo (0.5mL Injection)

Biological: Saline Placebo

Interventions

RSV-F Vaccine BIOLOGICAL

Treatment Group A

Saline Placebo BIOLOGICAL

Treatment Group B

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Novavax: lead

Study Sites (10)

Nothern California Clinical Research

Redding, California, 96001, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Rapid Medical Research

Cleveland, Ohio, 44122, United States

Location

Clinical Research Associates

Nashville, Tennessee, 37203, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Lisa Jackson

Seattle, Washington, 98101, United States

Location

Marshfield Clinical Research Foundation

Wausau, Wisconsin, 54401, United States

Location

Study Officials

• Clinical Development

  Novavax, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 17, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

US (10)