Abstract
BackgroundSince 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 FindingsOpen 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 µg hemagglutinin) or 2 double (7.5 µg 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/SignificanceOur 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.Trial RegistrationClinicalTrials.gov NCT01155037
Highlights
Human immunodeficiency virus (HIV)-infected individuals are at increased risk of severe disease from numerous infections, including recurrent respiratory infections [1]
Brazil was seriously affected by H1N1pdm09 with 34,506 influenza-like severe acute respiratory infection cases (5,747 were laboratory-confirmed cases), most occurring during the winter season of 2009 [9]
From April through December 2009, during the fall/winter of the southern hemisphere, the H1N1pdm09 virus circulated in Brazil [16], and, by the end of 2009, over 2000 H1N1pdm09-related deaths were reported [9]
Summary
Human immunodeficiency virus (HIV)-infected individuals are at increased risk of severe disease from numerous infections, including recurrent respiratory infections [1]. The aim of this study was to measure seroconversion after 2 single versus 2 double doses of an adjuvanted H1N1pdm vaccine in HIV-infected participants compared to HIV-negative controls (NCT01155037). 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
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