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