NCT01290419

Safety Study of Respiratory Syncytial Virus (RSV)-Fusion (F) Protein Particle Vaccine

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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

Detailed description

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.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	RSV-F Particle Vaccine	Dose 1 + adjuvant / dose; Day 0 and Day 30
BIOLOGICAL	RSV-F Particle Vaccine	Dose 2 + adjuvant / dose; Day 0 and Day 30
BIOLOGICAL	RSV-F Particle Vaccine	Dose 3 + adjuvant / dose; Day 0 and Day 30
BIOLOGICAL	RSV-F Particle Vaccine	Dose 3 / dose; Day 0 and Day 30
BIOLOGICAL	Placebo	Placebo; Day 0 and Day 30
BIOLOGICAL	RSV-F Particle Vaccine	Dose 4 / dose; Day 0 and Day 30
BIOLOGICAL	RSV-F Particle Vaccine	Dose 4 + adjuvant / dose; Day 0 and Day 30

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-02-07
• Last updated: 2012-03-08

Locations

1 site across 1 country: United States