Systems Biological Responses to Influenza Vaccination in an HIV-infected and HIV-uninfected Adult Population in Kampala, Uganda

NCT01916759 NA COMPLETED

To use a systems biological approach to study the molecular signatures of innate and adaptive responses to vaccination in a HIV infected versus uninfected adult population in Kampala, Uganda.

Details

Lead sponsor	Emory University
Phase	NA
Status	COMPLETED
Enrolment	63
Start date	2013-06
Completion	2014-03

Conditions

• HIV
• Acquired Immunodeficiency Syndrome
• Influenza

Interventions

• Seasonal trivalent inactivated influenza vaccine (Vaxigrip®)

Primary outcomes

• In group and between group comparison of immune parameters and gene expressions that change significantly following vaccination with the seasonal trivalent influenza vaccine (Vaxigrip®) — From baseline (Day 0) to 100 days post vaccination
  Immune parameters or gene expressions that change significantly in groups over baseline post immunization and between the study groups will be analyzed. For immune parameters, we will use a two-sided paired t-test. Fold-change will be combined with the test p-value in a selection criterion as appropriate. The tentative selection criterion is p-value ≤ 0.01 and fold change ≥ 3. For the gene/miRNA expression data, we will use the method Significance Analysis of Microarrays (SAM) with paired design to find differentially expressed genes. False discovery rate (FDR) will be used as selection criterion. The tentative selection criterion is FDR ≤ 0.1.
• Proportion of subjects achieving 4-fold or greater hemagglutination inhibition (HAI)antibody titer increases. — From baseline (Day 0) to 100 days following primary vaccination
  Proportion of subjects in different study groups achieving 4-fold or greater hemagglutination inhibition (HAI)antibody titer increases will be tabulated at each time point (Days 0, 1, 3, 7, 14, 28 and 100) and plotted across time. Fisher's exact test will be used to make comparisons between the study groups.
• Calculating correlation coefficient between the immune parameter and vaccine immunogenicity, as measured by the humoral immune response against seasonal influenza. — From baseline (Day 0) to 100 days post vaccination
  For immune parameters, we will calculate the correlation coefficient between the immune parameter and vaccine immunogenicity, as measured by the humoral immune response against seasonal influenza. The p-values associated with the correlation coefficients will be used to select immune parameters that are associated with the respective adaptive immune responses. The tentative selection criterion is p-value ≤ 0.01. For gene expression data, we will use the method Significance Analysis of Microarrays (SAM) with quantitative outcome to identify genes that are significantly associated with the immune response. False discovery rate (FDR) will be used as selection criterion. The tentative selection criterion is FDR ≤ 0.1.
• Characterization of the gut microbiota to determine compositional differences between HIV-uninfected adults versus HIV-infected adults on HAART versus HIV-infected long-term non-progressors — From baseline (Day 0) to Day 28 post vaccination
  Gut mircobiota will be characterized to determine what compositional differences exist between HIV-uninfected adults versus HIV-infected adults on HAARt versus HIV-infected long-term non-progressors at baseline (Day 0), Day 7 and Day 28 post vaccination
• Correlation between microbiata status and the quality of immune response elicited in vaccinated individuals — From baseline (Day 0) to Day 28 post vaccination
  Determine whether the status of the microbita correlates with the quality of immune responses elicited in vaccinated individuals

Countries

Uganda