Clinical trial NCT01811823: Effect of HIV and/or Active Tuberculosis on the Immune Responses to Trivalent Influenza Vaccine (TIV) in Adults
Official title: Effect of HIV and/or Active Tuberculosis on the Humoral and Cell Mediated Immune Responses to Un-adjuvanted Trivalent Sub-unit Influenza Vaccine (TIV) in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
HIV
Tuberculosis
Keywords: Tuberculosis
HIV infection
Immune responses to Influenza vaccination
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
First posted: 2013-03-15
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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


Eligibility criteria: 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)

Primary outcomes:
measure: humoral antibody responses, measured by hemagglutinin inhibition assay (HAI), to each of three strains included in the seasonal non-adjuvanted trivalent influenza vaccine.
timeFrame: up to 6 weeks after end of the influenza season
Secondary outcomes:
measure: • To compare the effect of HIV-infection, tuberculosis (TB) and HIV-TB co-infection on vaccine-strain specific cell mediated immune responses, evaluated by ELISPOT assay, following non-adjuvanted TIV vaccination.
timeFrame: up to 6 weeks after the end of the influenza season
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Respiratory and Meningeal Pathogens research unit
state: Gauteng
Study officials:
affiliation: University of Witwatersrand, South Africa
name: Shabir A Madhi, PHD
role: PRINCIPAL_INVESTIGATOR
References: