At a glance
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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
In Brief
A Phase 1 clinical trial evaluating RSV-F Particle Vaccine and Placebo for Respiratory Syncytial Virus Infections. Completed, enrolled 150 participants across 1 site.
Detailed Summary
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
Study Details
Timeline
Interventions
Dose 1 + adjuvant / dose; Day 0 and Day 30
Dose 2 + adjuvant / dose; Day 0 and Day 30
Dose 3 + adjuvant / dose; Day 0 and Day 30
Dose 3 / dose; Day 0 and Day 30
Placebo; Day 0 and Day 30
Dose 4 / dose; Day 0 and Day 30
Dose 4 + adjuvant / dose; Day 0 and Day 30