Study of the Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49
The purpose of this study is to test an investigational vaccine known as "VAX161C." An "investigational" vaccine is one that is not licensed for commercial use in the by the United States (US) by the US Food and Drug Administration (FDA). VAX161C is a vaccine for the influenza A virus subtype H5N1 avian influenza virus (bird flu). In this study, the subject will receive the VAX161C vaccine at one of six doses to see which dose is the best. VaxInnate wants to find out how safe these doses of vaccines are and how well they are tolerated by people who receive them. To measure how effective each type of the vaccine is, VaxInnate will test the ability of the body to develop an immune response, which means how the body recognizes and defends itself against the influenza virus.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase I Study of the Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49|
- Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Assess safety, reactogenicity and tolerability. Symptoms will be collected from the memory aid adn from the information collected at the clinic visits. All symptoms will be graded according to severity. Response to vaccine will be categorized as local (arm pain, redness, bruising, etc.) or systemic (headace, muscle aches, fatigue, etc.) symptoms. Laboratory tests such as CRP, WBC, LFTs and cytokines collected before and after vaccination will also be analyzed. We will compare the types and severity of symptoms and laboratory results based on vaccine dose.
- Immunogenicity [ Time Frame: 6 months ] [ Designated as safety issue: No ]To assess serum immune response, sera collected at Days 0, 21, 42 and 180 will be analyzed for HAI, MN, serum IgG anti-HA and serum IgG anti-flagellin by Elisa. The geometric mean, seroconversion and seroprotection rates will be determined.
|Study Start Date:||September 2012|
|Study Completion Date:||December 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: VAX161-01C vaccine
Subjects will be injected into the arm on 2 occasions during the study, once on Day 0 and then again on Day 21 with the vaccine VAX161-01C
|Biological: VAX161-01C vaccine|
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|United States, Florida|
|Miami Research Associates|
|South Miami, Florida, United States, 33143|
|United States, Kansas|
|Johnson County Clinical Trials|
|Lenexa, Kansas, United States, 66219|
|Study Director:||David Taylor, MD||VaxInnate Corporation|