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

Emory University

Status: Completed

Conditions: Influenza; HIV; Acquired Immunodeficiency Syndrome

Treatments: Drug: Seasonal trivalent inactivated influenza vaccine (Vaxigrip®)

Study type: Interventional

Funder types: Other

Identifiers

NCT01916759

1U19AI090023-02 (U.S. NIH Grant/Contract)

IRB00058919

Details and patient eligibility

About

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.

Full description

This longitudinal, observational cohort study will be conducted at the Makerere University- Johns Hopkins University Research Collaboration, at the Mulago National Referral Hospital complex in Kampala Uganda. The study will consist of 2 groups. One group will consist of 25 healthy HIV uninfected adults and the other arm will consist of 35 HIV infected adults. Within the HIV infected arm there will be two groups, 25 HIV infected adults and 10 long term non-progressors. Vaccinees will receive a primary immunization at day 0, and blood samples will be obtained at days 0, 1, 3, 7, 14, 28 and 100 after immunization.

We will analyze the early molecular signatures (identified by microarray analyses, as well as by FACS analyses of innate immune cells and luminex analyses of cytokines and chemokines) that correlate and predict the later immune responses.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 3 patient groups

HIV uninfected adults

Other group

Description:

25 HIV uninfected adults enrolled at the Mulago National Referral Hospital complex in Kampala, Uganda will receive seasonal trivalent inactivated influenza vaccine (Vaxigrip®).

Treatment:

Drug: Seasonal trivalent inactivated influenza vaccine (Vaxigrip®)

HIV infected adults on HAART

Other group

Description:

25 HIV infected adults enrolled at the Mulago National Referral Hospital complex in Kampala, Uganda will receive seasonal trivalent inactivated influenza vaccine (Vaxigrip®).

Treatment:

Drug: Seasonal trivalent inactivated influenza vaccine (Vaxigrip®)

HIV-infected long-term non-progressors

Other group

Description:

10 HIV-infected long-term non-progressor adults enrolled at the Mulago National Referral Hospital complex in Kampala, Uganda will receive seasonal trivalent inactivated influenza vaccine (Vaxigrip®).

Treatment:

Drug: Seasonal trivalent inactivated influenza vaccine (Vaxigrip®)