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

French, Neil, Gordon, Stephen ORCID: https://orcid.org/0000-0001-6576-1116, Mwalukomo, Thandie, White, Sarah A, Mwafulirwa, Gershom, Longwe, Herbert, Mwaiponya, Martin and Zijlstra, Edward E (2010) 'A Trial of a 7-Valent Pneumococcal Conjugate Vaccine in HIV-Infected Adults'. New England Journal of Medicine, Vol 362, Issue 9, pp. 812-822.

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Abstract

Background
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.

Methods
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.

Results
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).

Conclusions
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:	Originally published in the New England Journal of Medicine, 2010;362:812-22. Official version at: http://content.nejm.org/cgi/content/abstract/362/9/812
Subjects:	WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503.5 Complications WC Communicable Diseases > Infection. Bacterial Infections > Bacterial Infections > WC 217 Pneumococcal infections
Digital Object Identifer (DOI):	https://doi.org/10.1056/NEJMoa0903029
Depositing User:	Users 43 not found.
Date Deposited:	11 Jun 2010 13:54
Last Modified:	07 Oct 2019 08:23
URI:	https://archive.lstmed.ac.uk/id/eprint/952

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