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

NCT ID: NCT01916759

Last Updated: 2014-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-03-31

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 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.

Conditions

HIV; Acquired Immunodeficiency Syndrome; Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

HIV uninfected adults

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

Group Type: OTHER

Seasonal trivalent inactivated influenza vaccine (Vaxigrip®)

Intervention Type: DRUG

Administer seasonal trivalent inactivated influenza vaccine (Vaxigrip®) and collect blood specimens at 0, 1, 3, 7, 14, 28 and 100 days following vaccination.

HIV infected adults on HAART

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

Group Type: OTHER

Seasonal trivalent inactivated influenza vaccine (Vaxigrip®)

Intervention Type: DRUG

Administer seasonal trivalent inactivated influenza vaccine (Vaxigrip®) and collect blood specimens at 0, 1, 3, 7, 14, 28 and 100 days following vaccination.

HIV-infected long-term non-progressors

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®).

Group Type: OTHER

Seasonal trivalent inactivated influenza vaccine (Vaxigrip®)

Intervention Type: DRUG

Administer seasonal trivalent inactivated influenza vaccine (Vaxigrip®) and collect blood specimens at 0, 1, 3, 7, 14, 28 and 100 days following vaccination.

Interventions

Seasonal trivalent inactivated influenza vaccine (Vaxigrip®)

Administer seasonal trivalent inactivated influenza vaccine (Vaxigrip®) and collect blood specimens at 0, 1, 3, 7, 14, 28 and 100 days following vaccination.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Makerere University

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Saad B. Omer, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saad B Omer, MBBS,MPH,PhD

Role: PRINCIPAL_INVESTIGATOR

Emory Unversity

Locations

Makere University- Johns Hopkins University Research Collaboration, at the Mulago National Referral Hospital

Kampala, , Uganda

Countries

Uganda

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Other Identifiers

1U19AI090023-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00058919

Identifier Type: -

Identifier Source: org_study_id