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

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2014 by University of Witwatersrand, South Africa

Sponsor:

Information provided by (Responsible Party):

Michelle Groome, University of Witwatersrand, South Africa

ClinicalTrials.gov Identifier:

NCT01811823

First received: February 21, 2013

Last updated: August 11, 2014

Last verified: August 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

February 21, 2013

Last Updated Date

August 11, 2014

Start Date ^ICMJE

March 2014

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

humoral antibody responses, measured by hemagglutinin inhibition assay (HAI), to each of three strains included in the seasonal non-adjuvanted trivalent influenza vaccine. [ Time Frame: up to 6 weeks after end of the influenza season ] [ Designated as safety issue: No ]

• 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01811823 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

• 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. [ Time Frame: up to 6 weeks after the end of the influenza season ] [ Designated as safety issue: No ]

• To compare the effect of HIV-infection, tuberculosis (TB) and HIV-TB co-infection on vaccine-strain specific cell mediated immune responses, evaluated by Enzyme-linked immunosorbent spot (ELISPOT) assay, following non-adjuvanted TIV vaccination.

The cell mediated Immunity (CMI) evaluations in this study will provide novel information on influenza-specific CMI in individuals with TB. Interferon gama- ELISPOT responses will be assessed on fresh Peripheral Blood Mononuclear Cells (PBMCs). Spots will be visualized with a ELISPOT plate reader. Background (non-specific) spots detected in the medium-containing wells will be subtracted from the wells stimulated with influenza antigens. Results will be reported as Spot forming cell (SFC)/106 PBMCs.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Influenza
HIV
Tuberculosis

Intervention ^ICMJE

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)

Other Name: Vaxigrip

Study Arm (s)

TIV

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)

Intervention: Biological: Trivalent Inactivated Influenza Vaccine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

360

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Listed Location Countries ^ICMJE

South Africa

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01811823

Other Study ID Numbers ^ICMJE

TIV_HIV_TB

Has Data Monitoring Committee

Responsible Party

Michelle Groome, University of Witwatersrand, South Africa

Study Sponsor ^ICMJE

University of Witwatersrand, South Africa

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Shabir A Madhi, PHD

University of the Witwatersrand

Information Provided By

University of Witwatersrand, South Africa

Verification Date

August 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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