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Sponsored by: |
University of Witwatersrand, South Africa |
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Information provided by: | University of Witwatersrand, South Africa |
ClinicalTrials.gov Identifier: | NCT00757900 |
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 uninfected individuals. Based upon the available data, the South African Thoracic Society has provisionally recommended the use of influenza vaccine in HIV infected individuals with CD4+ counts of > 200/ml and viral loads of < 100 000 copies/ml.(Green R et al. In press, SAMJ). This proposal is however based upon recommendations made elsewhere with minimal level of evidence regarding its benefit, and no evidence from countries with a high prevalence of HIV. Very few HIV infected adults, however, actually do receive influenza vaccine in South Africa, partly because of the absence of compelling data regarding the burden of disease in Africa as well as lack of vaccine effectiveness and issues related to physician awareness and access to influenza vaccine in the public immunization program.
The conflicting evidence, between developed countries and Africa, regarding the effectiveness of PPV highlight the drawbacks of extrapolating vaccine effectiveness data from developed countries to developing countries.
Differences in the epidemiology of HIV between developed countries in which the prevalence of HIV is low to that of high-burden sub-Saharan African countries include:
These differences may all contribute to differences in the risk and severity of influenza illness among HIV infected adults from these communities as well as possibly responsiveness and effectiveness of vaccination.
The investigators are conducting a double-blinded, placebo controlled randomized trial at the HIV treatment clinic at Helen Joseph Hospital to determine the effectiveness of influenza vaccination in HIV infected adults in South Africa. The significance of the findings from this study will help quantify the burden of influenza illness in African HIV infected adults, as well as assist in making more informed recommendations for the use of influenza vaccine in HIV infected adults and in guiding national policy for preparing for a future influenza virus-pandemic.
Condition | Intervention | Phase |
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HIV Influenza Vaccination HIV Infections |
Biological: MUTAGRIP |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of Influenza Vaccine in HIV Infected Adults |
Enrollment: | 507 |
Study Start Date: | April 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
To receive a sub-unit influenza vaccine
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Biological: MUTAGRIP
Purified polyvalent vaccine for active immunisation against influenza.The vaccine is an inactivated split virus mixture of different group A and B viral strains. One 0.5 ml dose, intramuscular route.
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2: No Intervention |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
South Africa, Gauteng | |
Helen Joseph Hospital | |
Johannesburg, Gauteng, South Africa |
Principal Investigator: | Shabir A Madhi, MBBCH PhD | University of the Witwatersrand |
Principal Investigator: | Ian Sanne, MBBCh | Clinical HIV Research Unit |
Responsible Party: | DST/NRF Vaccine Preventable Diseases (University of the Witwatersrand) ( Shabir A Madhi ) |
Study ID Numbers: | CHRU02 (Ethics ref no 080212) |
Study First Received: | September 19, 2008 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00757900 History of Changes |
Health Authority: | South Africa: National Health Research Ethics Council |
influenza, human |
Virus Diseases Sexually Transmitted Diseases, Viral Respiratory Tract Diseases Respiratory Tract Infections HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Influenza, Human Orthomyxoviridae Infections Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Orthomyxoviridae Infections Infection Immunologic Deficiency Syndromes |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections HIV Infections Sexually Transmitted Diseases Influenza, Human Lentivirus Infections Retroviridae Infections |