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Clinical Trial
. 2000 Jun 17;355(9221):2106-11.
doi: 10.1016/s0140-6736(00)02377-1.

23-valent pneumococcal polysaccharide vaccine in HIV-1-infected Ugandan adults: double-blind, randomised and placebo controlled trial

N French  1 , J Nakiyingi, L M Carpenter, E Lugada, C Watera, K Moi, M Moore, D Antvelink, D Mulder, E N Janoff, J Whitworth, C F Gilks
Affiliations
Clinical Trial

23-valent pneumococcal polysaccharide vaccine in HIV-1-infected Ugandan adults: double-blind, randomised and placebo controlled trial

N French et al. Lancet. .

Abstract

Background: Infection with Streptococcus pneumoniae is a frequent and serious problem for HIV-immunosuppressed adults. Vaccination is recommended in the USA and Europe, but there are no prospective data that show vaccine efficacy.

Methods: 1392 (937 female) HIV-1-infected adults in Entebbe, Uganda, were enrolled. 697 received 23-valent pneumococcal polysaccharide vaccine and 695 received placebo. The primary endpoint was first event invasive pneumococcal disease. Secondary endpoints included vaccine serogroup-specific invasive disease, all (probable and definite) pneumococcal events, all-cause pneumonia, and death.

Findings: First invasive events occurred in 25 individuals (24 bacteraemias, one pyomyositis), 15 in the vaccine arm and ten in the placebo arm (hazard ratio [HR] 1.47; 95% CI 0.7-3.3). 22 isolates (88%) were of vaccine-specific serogroups with 15 events in the vaccine arm compared with seven in the placebo arm (HR 2.10; 0.9-5.2). All pneumococcal events had a similar distribution (20 vs 14; HR 1.41; 0.7-2.8) though all-cause pneumonia was significantly more frequent in the vaccine arm (40 vs 21; HR 1.89; 1.1-3.2). Mortality was unaffected by vaccination.

Interpretation: 23-valent pneumococcal polysaccharide vaccination is ineffective in HIV-1-infected Ugandan adults and probably has little, or no, public health value elsewhere in sub-Saharan Africa. Increased rates of pneumococcal disease in vaccine recipients may necessitate a reappraisal of this intervention in other settings.

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Comment in

  • 23-valent pneumococcal vaccination and HIV.
    Dieye TN, Simonart T, Sow PS, Farber CM. Dieye TN, et al. Lancet. 2000 Sep 16;356(9234):1027. doi: 10.1016/s0140-6736(05)72643-x. Lancet. 2000. PMID: 11041418 No abstract available.
  • 23-valent pneumococcal vaccination and HIV.
    Spoulou V, Theodoridou M, Papaevangelou VG, Mostrou GI, Ioannidis JP. Spoulou V, et al. Lancet. 2000 Sep 16;356(9234):1027-8. doi: 10.1016/S0140-6736(05)72644-1. Lancet. 2000. PMID: 11041419 No abstract available.

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