Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years
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|ClinicalTrials.gov Identifier: NCT01560793|
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : September 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: VAX161 [STF2.HA5 H5N1]||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||224 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Phase I Study of the Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years|
|Study Start Date :||June 2012|
|Primary Completion Date :||June 2013|
|Study Completion Date :||November 2013|
Dose escalating study where subjects are treated with VAX161B at one of six dose levels. Subjects will be injected with VAX161B twice during the study at Day 0 and Day 21. The dosages are: 1 mcg; 2.5 mcg; 4 mcg; 6 mcg; 8 mcg; and 12 mcg.
Biological: VAX161 [STF2.HA5 H5N1]
dose escalating, 2 intramuscular doses given 21 days apart
- Safety [ Time Frame: 1 year ]Assess safety, reactogenicity and tolerability. Symptoms will be collected from the memory aid and 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 (headache, 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 mos. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560793
|United States, Florida|
|Miami Research Associates|
|Miami, Florida, United States, 33143|
|United States, Kansas|
|Johnson County Clin-Trials|
|Lenexa, Kansas, United States, 66219|
|Principal Investigator:||Eric Sheldon, MD||Miami Research Associates|
|Principal Investigator:||Casey Johnson, DO||Johnson County Clin-Trials|