Safety Study of Respiratory Syncytial Virus F (RSV-F) Vaccine to Treat the Respiratory Syncytial Virus in Healthy Adults 18 to 49 Years of Age
| Status: | Archived |
|---|---|
| Conditions: | Infectious Disease, Pulmonary |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | December 2010 |
| End Date: | November 2011 |
A Phase 1 Randomized, Observer-Blinded,Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Recombinant Respiratory Syncytial Virus F Protein Particle Vaccine in Healthy Adults
A Phase 1, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study
to Assess the Safety, and immunogenicity of 4 different recombinant RSV-F formulations in
healthy adults (18 to 49 years of age).
Study Objectives:
Primary:
- To assess and compare the safety, reactogenicity, and tolerability of 4 Respiratory
Syncytial Virus F (RSV-F) vaccine formulations.
Secondary:
- To assess and compare the immunogenicity (neutralizing and total anti-F antibody) of
the 4 RSV-F vaccine formulations
- to confirm the "dose sparing" and "value added" effects of the aluminum phosphate
adjuvant
A total of 100 subjects will be allocated to 4 cohorts. Subjects will be randomly assigned
to vaccine treatment or saline placebo in a 4:1 ratio, such that each cohort will include 20
subjects who receive active vaccine (Groups A, B, C, or D) and 5 subjects who receive
placebo (Group E).
Subjects will be followed for all AEs, including SAEs and non-serious AEs, from the time of
each vaccination through 30 days following the second vaccination (Day 60±5). After Day 60,
subjects will be contacted via telephone on a monthly basis (approximately Days 90, 120,
150, 180, and 210) and asked about the occurrence of SAEs and SNMCs.
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