NCT01811823

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 Humoral and Cell Mediated Immune Responses to Un-adjuvanted Trivalent Sub-unit Influenza Vaccine (TIV) in Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: University of Witwatersrand, South Africa · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Conditions

• Influenza
• HIV
• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	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)

Timeline

• Start date: 2014-03-31
• Primary completion: 2014-11-20
• Completion: 2014-11-20
• First posted: 2013-03-15
• Last updated: 2018-09-05

Locations

1 site across 1 country: South Africa