Status:
COMPLETED
Efficacy of Influenza Vaccine in HIV Infected Adults
Lead Sponsor:
University of Witwatersrand, South Africa
Conditions:
HIV
Influenza
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
Vaccination of HIV infected individuals with the sub-unit influenza vaccine is safe; however it induces only moderate immune responses and likewise is modest in its protection compared to HIV uninfect...
Eligibility Criteria
Inclusion
- HIV infected adult on stable first line HAART for more than 3 months or anti-retroviral naïve HIV infected adult with a CD4+ cell count \>100 cells/ml performed within the previous 3 months in relation to the date of randomization.
- Age 18-55 years.
- Willing and able to maintain weekly contact at least during period of April - August (i.e. presupposed influenza period) either through SMS or telephonic contact.
- Willing and able to adhere to study protocol re: attendance to clinic for scheduled and illness visits.
Exclusion
- Any contraindication to influenza vaccination, including known allergy to egg.
- Currently on treatment for tuberculosis or received treatment for tuberculosis in the past 6 months.
- History of chronic lung disease which required maintenance therapy either currently or in the past 6 months.
- Any contraindication to intramuscular injections.
- Current known grade 3 or grade 4 laboratory or clinical toxicity as per DAIDS toxicity tables.
- Any previous history of influenza or pneumococcal vaccination.
- Any plan to vaccinate against influenza or pneumococcal disease during the course of the study.
- Plan to emigrate from the study area within the next year.
- On steroid therapy for \>21 days (current or within the past 30 days).
- In the investigators opinion unable to maintain study procedures.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
507 Patients enrolled
Trial Details
Trial ID
NCT00757900
Start Date
April 1 2008
End Date
September 1 2008
Last Update
October 9 2008
Active Locations (1)
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1
Helen Joseph Hospital
Johannesburg, Gauteng, South Africa