23-valent pneumococcal polysaccharide vaccine in HIV-1-infected Ugandan adults: double-blind, randomised and placebo controlled trial
23-valent pneumococcal polysaccharide vaccine in HIV-1-infected Ugandan adults: double-blind, randomised and placebo controlled trial
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DOI：
10.1016/s0140-6736(00)02377-1
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发表时间：
2000-06-17
期刊：
影响因子：
168.9
通讯作者：
Gilks, CF
中科院分区：
文献类型：
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作者：
French, N;Nakiyingi, J;Gilks, CF
背景肺炎链球菌感染是HIV免疫抑制成年人常见且严重的问题。美国和欧洲推荐接种疫苗，但没有前瞻性的数据显示疫苗的效果。方法在乌干达恩德培，1392名(937名女性)HIV-1感染者进入调查。697人接种了23价肺炎球菌多糖疫苗，695人接种了安慰剂。主要终点是首次事件侵袭性肺炎球菌病。次要终点包括特定于疫苗血清组的侵袭性疾病、所有(可能和确定的)肺炎球菌事件、全原因肺炎和死亡。发现首次侵袭性事件发生在25人(24例菌血症，1例脓肌炎)中，15例在疫苗组，10例在安慰剂组(风险比[HR]1.47；95%可信区间0.7-3.3)。22株(88%)分离株属于疫苗特异性血清组，疫苗组有15起事件，而安慰剂组有7起(HR 2.10；0.9-5.2)。所有肺炎球菌事件的分布相似(20比14；HR 1.41：0.7-2.8)，尽管疫苗组的全因肺炎明显更常见(40比21；HR 1.89；1.1-3.2)。死亡率不受疫苗接种的影响。解释23价肺炎球菌多糖疫苗对感染HIV-1的乌干达成年人无效，在撒哈拉以南非洲的其他地方可能几乎没有公共卫生价值。疫苗接受者肺炎球菌疾病发病率的增加可能需要在其他环境中重新评估这一干预措施。
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.