H1N1pdm09 Adjuvanted Vaccination in HIV-Infected Adults: A Randomized Trial of Two Single versus Two Double Doses
2012
Background: Since human immunodeficiency virus (HIV)-infected individuals are at increased risk of severe disease from
pandemic influenza A (H1N1pdm09), vaccination was recommended as a prevention strategy. The aim of the present study
was to evaluate the safety, immunogenicity and persistence of the immune response after vaccination against pandemic
influenza A (H1N1pdm09) with an adjuvanted vaccine in human immunodeficiency virus (HIV)-infected adults using two
single and two double doses.
Methodology/Principal Findings: Open label, randomized trial to evaluate the immune response following H1N1pdm09
vaccination in HIV-infected participants compared to HIV-negative controls (NCT01155037). HIV-infected participants were
randomized to receive 2 single (3.75 mg hemagglutinin) or 2 double (7.5 mg hemagglutinin) doses of the vaccine, 21 days
apart. Controls received one dose of the vaccine. The primary endpoint was seroconversion as measured by
hemagglutination inhibition assay. Two hundred fifty six HIV-infected participants (129 and 127 randomized to single
and double doses, respectively) and 71 HIV-negative controls were enrolled. Among HIV-infected participants,
seroconversion increased from 46.7% and 51.7% after the first dose to 77.2% and 83.8% after the second dose of the
vaccine using single and double doses, respectively. Participants aged .40 years showed higher seroconversion compared
to younger participants. Seroconversion among HIV-infected women and those with nadir CD4,200 cells/mm3 was
significantly higher with double doses. Persistence of protective antibodies six months after vaccination was achieved by
80% and 89.9% of the HIV-infected participants who received single and double doses, respectively.
Conclusions/Significance: Our results support the recommendation of two double doses of adjuvanted H1N1pdm09
vaccine for HIV-infected individuals, particularly women, and those aged .40 years or with nadir CD4,200 cells/mm3, to
achieve antibody levels that are both higher and more sustained.
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