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 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.


RESULTS
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.


CONCLUSIONS
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.
French
N
N
Liverpool School of Tropical Medicine, UK.
Nakiyingi
J
J
Carpenter
L M
LM
Lugada
E
E
Watera
C
C
Moi
K
K
Moore
M
M
Antvelink
D
D
Mulder
D
D
Janoff
E N
EN
Whitworth
J
J
Gilks
C F
CF
D017088:AIDS-Related Opportunistic Infections / Q000517:prevention & control*; D000328:Adult; D001428:Bacterial Vaccines; D018791:CD4 Lymphocyte Count; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000150:complications*; D015497:HIV-1; D006801:Humans; D008297:Male; D011008:Pneumococcal Infections / Q000401:mortality / Q000517:prevention & control*; D022242:Pneumococcal Vaccines; D016016:Proportional Hazards Models; D013296:Streptococcus pneumoniae / Q000302:isolation & purification; D014454:Uganda
D001428:Bacterial Vaccines; D022242:Pneumococcal Vaccines