Safety and Immunogenicity of VAX125 Influenza Vaccine in Community-living Adults >= 65 Years of Age
A multi-center, open-label, escalating dose-ranging study to assess the safety, reactogenicity, and immunogenicity of four different VAX125 vaccine doses; 0.5 µg, 1.0 µg, 2.0 µg, or 3.0 µg, delivered i.m. as a single dose vaccination on Day 0. Hypothesis: VAX125 is safe and immunogenic at one or more of the doses tested.
VaxInnate Corporation has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Phase II, Open-label, Escalating Dose-ranging Study to Evaluate the Safety and Immunogenicity of VAX125 Influenza Vaccine in Community-living Adults ≥65 Years of Age|
- Number of Participants With Local and Systemic Immediate Reactogenicity Complaints [ Time Frame: within 4 hours following vaccination ] [ Designated as safety issue: Yes ]
- Geometric Mean Hemagglutinin Inhibition (HAI) Antibody Titers [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
HA1 influenza vaccine
STF2.HA1(SI) (VAX125), which is a recombinant fusion protein that consists of Salmonella typhimurium flagellin type 2 (STF2), a Toll-like receptor 5 (TLR5) ligand, fused at its C-terminus to the globular head domain of the hemagglutinin (HA) antigen of influenza A HA1 Solomon Islands (SI).
A total of 80 community-living adults who are ≥65 years of age will be enrolled across the four dose groups. Following vaccination, each subject will remain at the study site for at least 30 minutes to be observed for any immediate reactogenicity complaints associated with the Day 0 vaccination. Subjects will also be evaluated during clinic visits on Study Days 1, 7, 14, and 28 following vaccination. In addition, a safety follow-up telephone contact will occur on post vaccination Day 3.
There will be 20 subjects per dose group. Up to 3 study sites will enroll 6-10 subjects per dose group over a two-day enrollment period. Progression to the next higher dose group will take place only if the Safety Monitoring Committee (SMC) assessment of the 30 (+15) minutes, Day 0, and Day 1 post vaccination safety data; Day 3 telephone report: and the Day 0 and Day 1 serum C-reactive protein (CRP) results concludes that the lower dose was well tolerated.
|United States, Kansas|
|Lanexa, Kansas, United States, 66219|
|United States, New York|
|Univ of Rochester|
|Rochester, New York, United States, 14642|
|United States, South Carolina|
|Coastal Carolina Research Center|
|Charleston, South Carolina, United States, 29464|