Effect of HIV and/or Active Tuberculosis on the Immune Responses to Trivalent Influenza Vaccine (TIV) in Adults (TIV_HIV_TB)

University of Witwatersrand

Status and phase: Completed; Phase 4

Conditions: Tuberculosis; Influenza; HIV

Treatments: Biological: Trivalent Inactivated Influenza Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01811823

TIV_HIV_TB

Details and patient eligibility

About

Prospective, open-labelled study which will enrol 360 participants in four groups of 80 participants including: HIV-uninfected adults without evidence of TB; HIV-infected adults without any evidence of TB; HIV-uninfected adults with concurrent microbiologic confirmed TB, HIV-infected adults with concurrent microbiologic confirmed TB.

Participants will receive the recommended seasonal 2013 un-adjuvanted Trivalent Influenza Vaccine (TIV). At 3 visits, blood will be collected for determination of immune responses.

Objective:

• To determine the effect of HIV-infection, tuberculosis (TB) and HIV-TB co-infection on immune responses

Enrollment: 301 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• for HIV-infected subjects: a Cluster of Differntiation4 (CD4+) cell count of >100/ul within the previous 3 months;
• able to attend the clinic for immunogenicity and illness visits;
• for subjects with TB: having a microbiologic confirmed diagnosis of TB (defined as the presence of acid-fast-bacilli (AFB) on a sputum smear or other specimen and/or a positive culture for M. tuberculosis) within the past 120 days;
• Aged 18 to 55 years.

Exclusion criteria

• any contraindication to influenza vaccine;
• any contraindication to intramuscular injections;
• any existing grade 3 or grade 4 laboratory or clinical toxicity as per Division of Acquired Immune Deficiency Syndrome (DAIDS) toxicity tables;
• systemic steroid treatment for >21 days within the past 30 days.
• pregnancy (a urine Human Chorionic Gonadotropin (βHCG) will be performed on all women of childbearing age to exclude pregnancy)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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301 participants in 1 patient group

TIV

Other group

Description:

Trivalent Inactivated Influenza Vaccine The study vaccine will be the seasonal 2013 un-adjuvanted TIV which is provided as a 0•5 milliliter suspension of split virus mixture of 15 micrograms each of circulating H1N1- like strain, H3N2- like strain and B - like strain. The WHO recommended vaccine formulation for Southern Hemisphere 2013 Influenza Season contains the following influenza strains: * A/California/7/2009 (H1N1)pdm-like virus * A/Victoria/361/2011 (H3N2)-like virus * B/Wisconsin/1/2010-like virus. (Yamagata lineage)

Treatment:

Biological: Trivalent Inactivated Influenza Vaccine