Respiratory Syncytial Virus Infections Clinical Trial
Official title:
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 6 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 6 RSV-F protein
particle vaccine formulations.
Secondary:
- To assess and compare the immunogenicity (neutralizing antibody and total anti-F
antibody) of the 6 RSV-F protein particle vaccine formulations
- To confirm the "dose sparing" and "value added" effects of the aluminum phosphate
adjuvant
A total of 150 subjects will be allocated to 7 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, D, F and G) 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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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