Status:
COMPLETED
Effect of HIV and/or Active Tuberculosis on the Immune Responses to Trivalent Influenza Vaccine (TIV) in Adults
Lead Sponsor:
University of Witwatersrand, South Africa
Conditions:
Influenza
HIV
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
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 o...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 31 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2014
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT01811823
Start Date
March 31 2014
End Date
November 20 2014
Last Update
September 5 2018
Active Locations (1)
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1
Respiratory and Meningeal Pathogens research unit
Johannesburg, Gauteng, South Africa, 2013