French Neil, Gordon Stephen B, Mwalukomo Thandie, White Sarah A, Mwafulirwa Gershom, Longwe Herbert, Mwaiponya Martin, Zijlstra Eduard E, Molyneux Malcolm E, Gilks Charles F
Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi; Karonga Prevention Study, London School of Hygiene and Tropical Medicine, Karonga, Malawi.
Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi; Liverpool School of Tropical Medicine, Liverpool, United Kingdom.
Malawi Med J. 2016 Sep;28(3):115-122.
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.
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.
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).
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.).
在成人人类免疫缺陷病毒（HIV）感染者中，尤其是在非洲，[疾病名称未给出]是一种主要且严重的合并感染。使用目前的23价多糖疫苗进行预防效果欠佳。蛋白结合疫苗为预防提供了另一种选择，但需要有关其在成人中的临床疗效的数据。
在这项双盲、随机、安慰剂对照的临床疗效试验中，我们研究了7价肺炎球菌结合疫苗对主要为感染HIV的马拉维青少年和已从确诊的侵袭性肺炎球菌疾病中康复的成人的疗效。相隔4周接种两剂疫苗。主要终点是由疫苗血清型或6A血清型引起的肺炎球菌感染的再次发作。
从2003年2月至2007年10月，我们对496例患者（其中44%为男性，88%为HIV血清阳性）进行了798人年的观察。52例患者发生了67次肺炎球菌疾病发作，均在HIV感染亚组中。在24例患者中，19次发作由疫苗血清型引起，5次发作由6A血清型引起。在这些发作中，5次发生在疫苗组，19次发生在安慰剂组，疫苗效力为74%（95%置信区间[CI]，30至90）。疫苗组有73例因任何原因死亡，安慰剂组有63例（疫苗组的风险比为1.18；95%CI，0.84至1.66）。疫苗组接种后14天内严重不良事件的数量显著低于安慰剂组（3例对17例，P = 0.002），疫苗组轻微不良事件的数量显著高于安慰剂组（41例对13例，P = 0.003）。
7价肺炎球菌结合疫苗可保护HIV感染的成人免受由疫苗血清型或6A血清型引起的复发性肺炎球菌感染。（当前对照试验编号，ISRCTN54494731。）
