Status:
COMPLETED
Differences in Response to the Flu Vaccine Among Adults With HIV and Without HIV in Uganda
Lead Sponsor:
Emory University
Collaborating Sponsors:
Makerere University
Conditions:
HIV
Acquired Immunodeficiency Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- For HIV uninfected group
- Confirmation of HIV-1 infection from medical records
- 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
- 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
- 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)
- 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
- Received immunoglobulin or other blood product within the preceding 3 months or expected receipt of blood products during the 3 months of follow-up
- 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)
- History of severe reaction (including hypersensitivity) after receiving any vaccine
- Currently pregnant
- In the opinion of the study team it would be unsuitable for the study subjects to receive the vaccine or participate in the study.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01916759
Start Date
June 1 2013
End Date
March 1 2014
Last Update
April 23 2014
Active Locations (1)
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1
Makere University- Johns Hopkins University Research Collaboration, at the Mulago National Referral Hospital
Kampala, Uganda