Differences in Response to the Flu Vaccine Among Adults With HIV and Without HIV in Uganda

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Collaborator: Makerere University
• Treatments: Vaccines

Criteria

Inclusion Criteria:

1. For HIV uninfected group

• Confirmation of HIV-1 infection from medical records

2. For HIV infected on HAART group

• Confirmation of HIV-1 infection from medical records

• Participants must be on HAART for at least 6 months prior to enrollment

• A CD4 T-cell count available in the last 6 months

• CD4 T-cell count >350 cells/μL on the eligibility blood specimen

3. Long-term non-progressor group

• HIV infected for more than 7 years

• No evidence of opportunistic infections in the medical records

• Never received antiretroviral therapy (except anti-retrovirals for prevention of mother-to-infant transmission of HIV)

• A CD4 T-cell count available in the last 6 months

• CD4+ T-cell count slop of ≥0 cells/µl blood from entry into the MU-JHU cohort until the most recent available CD4+ T-cell count.

Exclusion Criteria:

1. Current moderate or severe acute illness, history of fever or temperature ≥37.5oC within 48 hours prior to vaccination (participants can be re-evaluated at a subsequent visit)

2. History of systemic disease, including: Guillain-Barré Syndrome; known hepatitis B, or hepatitis C infection; cardiac disease; uncontrolled diabetes mellitus (including gestational diabetes); chronic liver condition; clinically significant renal impairment; clinically significant neurological disorders; active TB within the last year; Cancer. This information will be based on self-reporting and (where possible) will be confirmed by hospital medical records

3. Received immunoglobulin or other blood product within the preceding 3 months or expected receipt of blood products during the 3 months of follow-up

4. History of anaphylactic hypersensitivity reactions to egg proteins (eggs or egg products), or any other component of the vaccine including traces (formaldehyde, octoxinol 9 (Triton X-100) and neomycin)

5. History of severe reaction (including hypersensitivity) after receiving any vaccine

6. Currently pregnant

7. In the opinion of the study team it would be unsuitable for the study subjects to receive the vaccine or participate in the study.