Effect of HIV and/or Active Tuberculosis on the Immune Responses to Trivalent Influenza Vaccine (TIV) in Adults
NCT ID: NCT01811823
Last Updated: 2018-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
301 participants
INTERVENTIONAL
2014-03-31
2014-11-20
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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)
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)
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
55 Years
ALL
No
Sponsors
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University of Witwatersrand, South Africa
OTHER
Responsible Party
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Shabir Madhi
Dr
Principal Investigators
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Shabir A Madhi, PHD
Role: PRINCIPAL_INVESTIGATOR
University of Witwatersrand, South Africa
Locations
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Respiratory and Meningeal Pathogens research unit
Johannesburg, Gauteng, South Africa
Countries
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Other Identifiers
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TIV_HIV_TB
Identifier Type: -
Identifier Source: org_study_id
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