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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Trivalent inactivated influenza vaccine in African adults infected with human immunodeficient virus: Double blind, randomized Clinical trial of efficacy, immunogenicity, and safety
Clinical Infectious Diseases, Volume 52, No. 1, Year 2011
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Description
Background: Data on the efficacy of trivalent, inactivated influenza vaccine (TIV) in HIV-infected adults, particularly in Africa, are limited. This study evaluated the safety, immunogenicity, and efficacy of TIV in HIV-infected adults. Methods: In Johannesburg, South Africa, we undertook a randomized, double-blind, placebo-controlled trial involving 506 HIV-infected adults. Subjects included 157 individuals who were antiretroviral treatment (ART) naive and 349 on stable-ART. Participants were randomly assigned to receive TIV or normal saline intramuscularly. Oropharyngeal swabs were obtained at illness visits during the influenza season and tested by shell vial culture and RT PCR assay for influenza virus. Immune response was evaluated by hemagglutinin antibody inhibition assay (HAI) in a nested cohort. The primary study outcome involved vaccine efficacy against influenza confirmed illness. This trial is registered with ClinicalTrials.gov, number NCT00757900. Results: The efficacy of TIV against confirmed influenza illness was 75.5% (95% CI: 9.2%-95.6%); with a risk difference of 0.18 per 100 person-weeks in TIV recipients. Among TIV recipients, seroconversion, measured by HAI titers, was evident in 52.6% for H1N1, 60.8% for H3N2, and 53.6% for influenza B virus. This compared with 2.2%, 2.2%, and 4.4% of placebo recipients (P <.0001). The frequency of local and systemic adverse events postimmunization was similar between study groups. Conclusions: TIV immunization is safe and efficacious in African HIV-infected adults without underlying comorbidities. Further evaluation of effectiveness is warranted in severely immunocompromized HIV-infected adults and those with co-morbidities such as tuberculosis. © The Author 2011. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please.
Authors & Co-Authors
Madhi, Shabir A.
South Africa, Johannesburg
University of the Witwatersrand
Maskew, Mhairi
South Africa, Johannesburg
University of the Witwatersrand
Koen, Anthonet Lombard
South Africa, Johannesburg
University of the Witwatersrand
Kuwanda, Locadiah
South Africa, Johannesburg
University of the Witwatersrand
Besselaar, Terry G.
South Africa, Johannesburg
National Health Laboratory Service
Naidoo, Dhamari
South Africa, Johannesburg
National Health Laboratory Service
Cohen, Cheryl D.
South Africa, Johannesburg
National Health Laboratory Service
South Africa, Johannesburg
Wits School of Public Health
Valette, Martine
France, Lyon
Chu de Lyon
Cutland, Clare Louise
South Africa, Johannesburg
University of the Witwatersrand
Sanne, Ian
South Africa, Johannesburg
University of the Witwatersrand
Statistics
Citations: 102
Authors: 10
Affiliations: 4
Identifiers
Doi:
10.1093/cid/ciq004
ISSN:
10584838
e-ISSN:
15376591
Research Areas
Disability
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial
Cohort Study
Study Locations
South Africa