Effect of HIV and/or Active Tuberculosis on the Immune Responses to Trivalent Influenza Vaccine (TIV) in Adults
TIV_HIV_TB
1 other identifier
interventional
301
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2013
CompletedFirst Posted
Study publicly available on registry
March 15, 2013
CompletedStudy Start
First participant enrolled
March 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2014
CompletedSeptember 5, 2018
September 1, 2018
8 months
February 21, 2013
September 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
humoral antibody responses, measured by hemagglutinin inhibition assay (HAI), to each of three strains included in the seasonal non-adjuvanted trivalent influenza vaccine.
• To determine the effect of HIV-infection, tuberculosis (TB) and HIV-TB co-infection on humoral antibody responses, measured by hemagglutinin inhibition assay (HAI), to each of three strains included in the seasonal non-adjuvanted trivalent influenza vaccine In this study we will use the following definitions to assess the humoral immune response to TIV: HAI titers \<1:10 = seronegative; HAI titers ≥1:10 = seropositive; HAI titers ≥1:40 = sero-protective; sero-response rate (primary outcome measure) will be defined as a titer of ≥1:40 in an individual with baseline titers of \<1:10, or \>4-fold increase of HAI titers if baseline titers were ≥1:10. Hemagglutination inhibition assays will be performed on serum as per recommended methods. Sera will be titrated against antigens from the influenza vaccine strains included in the 2013 seasonal TIV.
up to 6 weeks after end of the influenza season
Secondary Outcomes (1)
• 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.
up to 6 weeks after the end of the influenza season
Study Arms (1)
TIV
OTHERTrivalent 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)
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Respiratory and Meningeal Pathogens research unit
Johannesburg, Gauteng, 2013, South Africa
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shabir A Madhi, PHD
University of Witwatersrand, South Africa
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
February 21, 2013
First Posted
March 15, 2013
Study Start
March 31, 2014
Primary Completion
November 20, 2014
Study Completion
November 20, 2014
Last Updated
September 5, 2018
Record last verified: 2018-09