Influenza Clinical Trial
Official title:
A Randomized, Double-Blinded, Controlled, Phase I Study in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of Intramuscular Subvirion Inactivated Monovalent Influenza A/H5N1 Virus Vaccine Administered With and Without AS03 Adjuvant: Standard & Systems Biology Analyses
This is a single center, randomized, double-blinded, controlled, Phase I, small targeted prospective study in healthy male and non-pregnant female subjects, 18 to 49 years old, inclusive, designed to determine the safety, reactogenicity, and immunogenicity of an intramuscular subvirion inactivated monovalent influenza A/H5N1 (HA of A/Indonesia/05/2005) virus vaccine manufactured by Sanofi Pasteur administered at 3.75 mcg per dose given with or without AS03 adjuvant manufactured by GSK. In the study, each subject will receive two doses administered 28 days apart. This study will use a systems biology approach to assess the human early gene and protein signatures expressed at Days 1, 3, 7, and 28 after the first vaccination. The systems data will be integrated with immunogenicity and reactogenicity data to develop a systems model of the human immune response to A/H5N1 vaccine with or without AS03 adjuvant.
The long term goals of this project are to identify RNA or protein biomarkers within 1 to 7 days after vaccination in peripheral blood that will predict a successful immune response and protection against disease. Adjuvants are used to boost the response of vaccines by stimulating the innate immune response. However, the exact mechanism and safety of adjuvants is still debated. Systems biology is the study of complex biological processes as integrated systems with many interacting components. The goal of systems biology is to make biology more predictive. This proposal will use a systems biology approach to identify successful immunization biomarkers. The study will use fresh blood samples and patient data collected in the proposed VTEU-funded study. At selected time points, volunteers' blood samples will be collected and immediately processed. Using these specimens, we will identify and quantify changes in the whole transcriptome and proteome of the major immune cells to identify and quantify changes in gene expression. We will integrate the changes in gene expression with the changes in the immune cells response. We will use mathematical modeling of the accumulated data to identify RNA or protein biomarkers that significantly correlate with the observed serum hemagglutination inhibition assay (HAI) response,cytokine/chemokine response, and cell mediated immunity (CMI) responses. Ultimately, the predictive biomarkers will be the foundation for a simple, rapid, inexpensive test to quickly show protection against a pathogen or foreign agent after vaccination. This is a single center, randomized, double-blinded, controlled, Phase I, small targeted prospective study in healthy male and non-pregnant female subjects, 18 to 49 years old, inclusive, designed to determine the safety, reactogenicity, and immunogenicity of an intramuscular subvirion inactivated monovalent influenza A/H5N1 (HA of A/Indonesia/05/2005) virus vaccine manufactured by Sanofi Pasteur administered at 3.75 mcg per dose given with or without AS03 adjuvant manufactured by GSK. In the study, each subject will receive two doses administered 28 days apart. ;
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