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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 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: December 10, 2013
Last verified: December 2013

February 21, 2013
December 10, 2013
March 2014
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01811823 on ClinicalTrials.gov Archive Site
• 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.

Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Influenza
  • HIV
  • Tuberculosis
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
360
December 2014
December 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years to 55 Years
No
South Africa
 
NCT01811823
TIV_HIV_TB
No
Michelle Groome, University of Witwatersrand, South Africa
University of Witwatersrand, South Africa
Not Provided
Principal Investigator: Shabir A Madhi, PHD University of the Witwatersrand
University of Witwatersrand, South Africa
December 2013

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