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Influenza Vaccine Project Groups 7 and 8

Influenza Vaccine Project Groups 7 and 8 . Compared to a standard dose of an influenza trivalent vaccine, does a high dose of the vaccine confer greater efficacy in preventing influenza-like illness among HIV-positive adults?. Study Rationale.

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Influenza Vaccine Project Groups 7 and 8

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  1. Influenza Vaccine ProjectGroups 7 and 8 • Compared to a standard dose of an influenza trivalent vaccine, does a high dose of the vaccine confer greater efficacy in preventing influenza-like illness among HIV-positive adults?

  2. Study Rationale • Individuals with HIV have less robust antibody responses to influenza vaccines. • Although data are limited, immunosuppressed individuals, including those with HIV, appear to be at greater risk for complications of influenza. • A recent trial in HIV positive participants found that a high dose (4x) influenza vaccine resulted in high antibody levels as compared to a standard dose of the vaccine. • Data comparing the two doses for clinical outcomes, as opposed to surrogate outcomes like vaccine-induced antibody titres, are not available.

  3. Questions To Consider • Study logistics, including duration of follow-up and location of sites. • Inclusion criteria (e.g., CD4+ cell count, use of antiretroviral treatment) • Estimation of influenza incidence in control group. • Definition and assessment of primary outcome.

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