Influenza vaccination of pregnant women and protection of their infants

Show simple item record Madhi, Shabir A. Cutland, Clare L. Kuwanda, Locadiah Weinberg, Adriana Hugo, Andrea Jones, Stephanie Adrian, Peter V. Van Niekerk, Nadia Treurnicht, Florette K. Ortiz, Justin R. Venter, Marietjie Violari, Avy Neuzil, Kathleen M. Simoes, Eric A.F. Klugman, Keith P. Nunes, Marta C. 2014-10-21T11:02:42Z 2014-10-21T11:02:42Z 2014
dc.description.abstract BACKGROUND There are limited data on the efficacy of vaccination against confirmed influenza in pregnant women with and those without human immunodeficiency virus (HIV) infection and protection of their infants. METHODS We conducted two double-blind, randomized, placebo-controlled trials of trivalent inactivated influenza vaccine (IIV3) in South Africa during 2011 in pregnant women infected with HIV and during 2011 and 2012 in pregnant women who were not infected. The immunogenicity, safety, and efficacy of IIV3 in pregnant women and their infants were evaluated until 24 weeks after birth. Immune responses were measured with a hemagglutination inhibition (HAI) assay, and influenza was diagnosed by means of reverse-transcriptase–polymerase-chain-reaction (RT-PCR) assays of respiratory samples. RESULTS The study cohorts included 2116 pregnant women who were not infected with HIV and 194 pregnant women who were infected with HIV. At 1 month after vaccination, seroconversion rates and the proportion of participants with HAI titers of 1:40 or more were higher among IIV3 recipients than among placebo recipients in both cohorts. Newborns of IIV3 recipients also had higher HAI titers than newborns of placebo recipients. The attack rate for RT-PCR–confirmed influenza among both HIV-uninfected placebo recipients and their infants was 3.6%. The attack rates among HIV-uninfected IIV3 recipients and their infants were 1.8% and 1.9%, respectively, and the respective vaccine-efficacy rates were 50.4% (95% confidence interval [CI], 14.5 to 71.2) and 48.8% (95% CI, 11.6 to 70.4). Among HIV-infected women, the attack rate for placebo recipients was 17.0% and the rate for IIV3 recipients was 7.0%; the vaccine-efficacy rate for these IIV3 recipients was 57.7% (95% CI, 0.2 to 82.1). CONCLUSIONS Influenza vaccine was immunogenic in HIV-uninfected and HIV-infected pregnant women and provided partial protection against confirmed influenza in both groups of women and in infants who were not exposed to HIV. (Funded by the Bill and Melinda Gates Foundation and others; numbers, NCT01306669 and NCT01306682.) en_US
dc.description.librarian am2014 en_US
dc.description.sponsorship The Bill and Melinda Gates Foundation (OPP1002747), the National Institutes of Health, National Center for Advancing Translational Sciences Colorado Clinical and Translational Sciences Institute (UL1 TR000154, for REDCap), the South African Research Chairs Initiative of the Department of Science and Technology and National Research Foundation in Vaccine-Preventable Diseases, and the Respiratory and Meningeal Pathogens Research Unit of the Medical Research Council. en_US
dc.description.uri en_US
dc.identifier.citation Madhi, SA, Cutland, CL, Kuwanda, L, Weinberg, A, Hugo, A, Jones, S, Adrian, PV, Van Niekerk, N, Treurnicht, F, Ortiz, JR, Venter, M, Violari, A, Neuzil, KM, Simoes, EAF, Klugman, KP & Nunes, MC 2014, 'Influenza vaccination of pregnant women and protection of their infants', New England Journal of Medicine, vol. 371, no. 10, pp. 918-931. en_US
dc.identifier.issn 1040-6387 (print)
dc.identifier.issn 1943-4936 (online)
dc.identifier.other 10.1056/NEJMoa1401480
dc.language.iso en en_US
dc.publisher Massachusetts Medical Society en_US
dc.rights © 2014 Massachusetts Medical Society en_US
dc.subject Vaccination en_US
dc.subject Infants en_US
dc.subject Protection en_US
dc.subject Influenza en_US
dc.subject Pregnant women en_US
dc.subject Human immunodeficiency virus (HIV) en_US
dc.title Influenza vaccination of pregnant women and protection of their infants en_US
dc.type Article en_US

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