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

Background Infection with Streptococcus pneumoniae is a frequent and seriou s problem for HIV-immunosuppressed adults. Vaccination is recommended in th e USA and Europe, but there are no prospective data that show vaccine effic acy. Methods 1392 (937 female) HIV-1-infected adults in Entebbe, Uganda, were en rolled. 697 received 23-valent pneumococcal polysaccharide vaccine and 695 received placebo. The primary endpoint was first event invasive pneumococca l disease. Secondary endpoints included vaccine serogroup-specific invasive disease, all (probable and definite) pneumococcal events, all-cause pneumo nia, 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-specif ic 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 distr ibution (20 vs 14; HR 1.41: 0.7-2.8) though all-cause pneumonia was signifi cantly more frequent in the vaccine arm (40 vs 21; HR 1.89; 1.1-3.2). Morta lity was unaffected by vaccination. Interpretation 23-valent pneumococcal polysaccharide vaccination is ineffec tive in HIV-1-infected Ugandan adults and probably has little, or no, publi c health value elsewhere in sub-Saharan Africa. Increased rates of pneumoco ccal disease in vaccine recipients may necessitate a reappraisal of this in tervention in other settings.