Efficacy of Influenza Vaccine in HIV Infected Adults
Condition: HIV; Influenza; Vaccination; HIV Infections
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

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 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:

        -  differences in the mode of transmission of HIV and demographics of the infected
           population.

        -  differences in standard of care, including access to prophylaxis against opportunistic
           infections and use of highly active anti-retroviral therapy (HAART)

        -  differences in risk for disease from opportunistic pathogens, e.g. Mycobacterium
           tuberculosis, etc.

      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.
    


Intervention name(s): MUTAGRIP
Intervention type(s): Biological
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza, human