The Effect of Oral Polio Vaccine at Birth on Infant Mortality: A Randomized Trial.
The Effect of Oral Polio Vaccine at Birth on Infant Mortality: A Randomized Trial.
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DOI：
10.1093/cid/civ617
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发表时间：
2015-11-15
期刊：
影响因子：
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通讯作者：
Benn CS
中科院分区：
文献类型：
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作者：
Lund N;Andersen A;Hansen AS;Jepsen FS;Barbosa A;Biering-Sørensen S;Rodrigues A;Ravn H;Aaby P;Benn CS
新生儿随机接种口服脊髓灰质炎疫苗（OPV），并随访死亡率。在头2天内入组的患者中，口服脊髓灰质炎疫苗与婴儿传染病死亡率降低42%（10%-62%）相关。出生时口服脊髓灰质炎疫苗可能对感染提供非特异性保护。背景。常规疫苗可能对死亡率有非特异性影响。一项观察性研究发现，出生时给予口服脊髓灰质炎疫苗（OPV0）与男婴死亡率增加有关。我们在几内亚比绍的一项随机试验中调查了OPV0对婴儿死亡率的影响。方法。7012名健康正常出生体重的新生儿随机分为仅接种卡介苗组（干预组）和接种OPV0联合接种卡介苗组（常规组）。所有儿童在6、10和14周龄时接受口服脊髓灰质炎疫苗和五价疫苗（白喉、破伤风、百日咳、b型流感嗜血杆菌和乙型肝炎）。在试验期间还开展了七次全国口服脊髓灰质炎疫苗运动。这些孩子被跟踪到12个月大。我们使用Cox回归计算死亡率的风险比（hr）。结果。该试验与最初关于OPV0增加男婴死亡率的假设相矛盾。在12个月内，BCG + OPV组有73名儿童死亡，仅BCG组有87名儿童死亡，均死于传染病。将BCG + OPV0与仅BCG进行比较，男孩的HR为0.83(95%可信区间[CI]， 0.61 - 1.13)：男孩的HR为0.72 (95% CI, 0.47 - 1.10)，女孩的HR为0.97 （95% CI, 0.61 - 1.54）。对于出生后2天内入组的儿童，卡介苗+ OPV0与仅卡介苗的HR为0.58 （95% CI, 0.38 - 0.90）。从入组到口服脊髓灰质炎疫苗接种，风险比为0.68 (95% CI, 0.45 - 1.00)，男性的有益效果显著（0.55 [95% CI, 0.32 - 0.95]）。结论。这是唯一一项OPV0对死亡率影响的随机试验。OPV0可能与预防传染病死亡率的非特异性保护有关，特别是在生命早期给予时。当口服脊髓灰质炎疫苗被逐步淘汰时，有理由监测死亡率。临床试验注册，NCT00710983。
Neonates were randomized to oral polio vaccine (OPV) and followed for mortality. Among those enrolled within the first 2 days, OPV was associated with a 42% (10%–62%) reduction in infant infectious disease mortality. OPV at birth may provide nonspecific protection against infections. Background. Routine vaccines may have nonspecific effects on mortality. An observational study found that OPV given at birth (OPV0) was associated with increased male infant mortality. We investigated the effect of OPV0 on infant mortality in a randomized trial in Guinea-Bissau. Methods. A total of 7012 healthy normal-birth-weight neonates were randomized to BCG only (intervention group) or OPV0 with BCG (usual practice). All children were to receive OPV with pentavalent vaccine (diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and hepatitis B) at 6, 10, and 14 weeks of age. Seven national OPV campaigns were also conducted during the trial period. Children were followed to age 12 months. We used Cox regression to calculate hazard ratios (HRs) for mortality. Results. The trial contradicted the original hypothesis about OPV0 increasing male infant mortality. Within 12 months, 73 children in the BCG + OPV group and 87 children in the BCG-only group died, all from infectious diseases. Comparing BCG + OPV0 vs BCG only, the HR was 0.83 (95% confidence interval [CI], .61–1.13): 0.72 (95% CI, .47–1.10) in boys and 0.97 (95% CI, .61–1.54) in girls. For children enrolled within the first 2 days of life, the HR for BCG + OPV0 vs BCG only was 0.58 (95% CI, .38–.90). From enrollment until the time of OPV campaigns, the HR was 0.68 (95% CI, .45–1.00), the beneficial effect being separately significant for males (0.55 [95% CI, .32–.95]). Conclusions. This is the only randomized trial of the effect of OPV0 on mortality. OPV0 may be associated with nonspecific protection against infectious disease mortality, particularly when given early in life. There are reasons to monitor mortality when OPV is being phased out. Clinical Trials Registration. NCT00710983.