Effect of HIV and/or Active Tuberculosis on the Immune Responses to Trivalent Influenza Vaccine (TIV) in Adults (TIV_HIV_TB)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01811823 |
Recruitment Status
: Unknown
Verified August 2014 by Michelle Groome, University of Witwatersrand, South Africa.
Recruitment status was: Recruiting
First Posted
: March 15, 2013
Last Update Posted
: August 12, 2014
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | February 21, 2013 | |||
First Posted Date ICMJE | March 15, 2013 | |||
Last Update Posted Date | August 12, 2014 | |||
Study 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 ] • 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 ] • 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: None (Open Label) Primary Purpose: Basic Science |
|||
Condition ICMJE |
|
|||
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:
Other Name: Vaxigrip |
|||
Study Arms | 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:
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 | Unknown status | |||
Estimated Enrollment ICMJE |
360 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date | December 2014 | |||
Estimated Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
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 | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Michelle Groome, University of Witwatersrand, South Africa | |||
Study Sponsor ICMJE | University of Witwatersrand, South Africa | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | 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 |