A Trial of a 7-Valent Pneumococcal Conjugate Vaccine in HIV-Infected Adults.

French, Neil ORCID: 0000-0003-4814-8293, Gordon, Stephen B ORCID: 0000-0001-6576-1116, Mwalukomo, Thandie, White, Sarah A, Mwafulirwa, Gershom, Longwe, Herbert, Mwaiponya, Martin, Zijlstra, Eduard E, Molyneux, Malcolm E and Gilks, Charles F (2010) A Trial of a 7-Valent Pneumococcal Conjugate Vaccine in HIV-Infected Adults. NEW ENGLAND JOURNAL OF MEDICINE, 362 (9). pp. 812-822. ISSN 0028-4793, 1533-4406

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Official URL: https://doi.org/10.1056/nejmoa0903029

Abstract

<h4>Background</h4>Streptococcus pneumoniae is a leading and serious coinfection in adults with human immunodeficiency virus (HIV) infection, particularly in Africa. Prevention of this disease by vaccination with the current 23-valent polysaccharide vaccine is suboptimal. Protein conjugate vaccines offer a further option for protection, but data on their clinical efficacy in adults are needed.<h4>Methods</h4>In this double-blind, randomized, placebo-controlled clinical efficacy trial, we studied the efficacy of a 7-valent conjugate pneumococcal vaccine in predominantly HIV-infected Malawian adolescents and adults who had recovered from documented invasive pneumococcal disease. Two doses of vaccine were given 4 weeks apart. The primary end point was a further episode of pneumococcal infection caused by vaccine serotypes or serotype 6A.<h4>Results</h4>From February 2003 through October 2007, we followed 496 patients (of whom 44% were male and 88% were HIV-seropositive) for 798 person-years of observation. There were 67 episodes of pneumococcal disease in 52 patients, all in the HIV-infected subgroup. In 24 patients, there were 19 episodes that were caused by vaccine serotypes and 5 episodes that were caused by the 6A serotype. Of these episodes, 5 occurred in the vaccine group and 19 in the placebo group, for a vaccine efficacy of 74% (95% confidence interval [CI], 30 to 90). There were 73 deaths from any cause in the vaccine group and 63 in the placebo group (hazard ratio in the vaccine group, 1.18; 95% CI, 0.84 to 1.66). The number of serious adverse events within 14 days after vaccination was significantly lower in the vaccine group than in the placebo group (3 vs. 17, P=0.002), and the number of minor adverse events was significantly higher in the vaccine group (41 vs. 13, P=0.003).<h4>Conclusions</h4>The 7-valent pneumococcal conjugate vaccine protected HIV-infected adults from recurrent pneumococcal infection caused by vaccine serotypes or serotype 6A. (Current Controlled Trials number, ISRCTN54494731.)

Item Type:	Article
Additional Information:	French, Neil Gordon, Stephen B Mwalukomo, Thandie White, Sarah A Mwafulirwa, Gershom Longwe, Herbert Mwaiponya, Martin Zijlstra, Eduard E Molyneux, Malcolm E Gilks, Charles F 061230/Wellcome Trust/United Kingdom 079828/Wellcome Trust/United Kingdom Wellcome Trust/United Kingdom N Engl J Med. 2010 Mar 4;362(9):812-22.## TULIP Type: Articles/Papers (Journal) ##
Uncontrolled Keywords:	Humans, Streptococcus pneumoniae, Pneumonia, Pneumococcal, AIDS-Related Opportunistic Infections, HIV Infections, Pneumococcal Vaccines, Vaccines, Conjugate, CD4 Lymphocyte Count, Multivariate Analysis, Risk Factors, Double-Blind Method, Adolescent, Adult, Aged, Middle Aged, Female, Male, Young Adult, Intention to Treat Analysis, Heptavalent Pneumococcal Conjugate Vaccine
Depositing User:	Symplectic Admin
Date Deposited:	02 Dec 2016 16:30
Last Modified:	07 Dec 2024 13:17
DOI:	10.1056/NEJMoa0903029
Open Access URL:	http://www.nejm.org/doi/full/10.1056/NEJMoa0903029
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3004753