Bernstein D I, Glass R I, Rodgers G, Davidson B L, Sack D A
Division of Clinical Virology, J. N. Gamble Institute of Medical Research, Cincinnati, Ohio 45219, USA.
JAMA. 1995 Apr 19;273(15):1191-6.
To determine the safety and relative efficacy of two reassortant rhesus rotavirus vaccines over two rotavirus seasons.
A prospective, double-masked, placebo-controlled trial.
Twenty-three centers in the United States.
A total of 1006 healthy infants between 4 and 26 weeks of age were enrolled, and 898 received three doses of vaccine or placebo.
Reactogenicity was determined by comparing the incidence of fever, diarrhea, and/or vomiting for 5 days after each dose of vaccine. Rotavirus IgA and neutralizing antibody to rhesus rotavirus and four rotavirus serotypes were measured in a subset of subjects. Relative efficacy was determined by comparing the incidence of rotavirus gastroenteritis after three doses of vaccine or placebo over two rotavirus seasons.
Adverse reactions were mild and limited to a small but significant increase in the incidence of fever after the first dose of tetravalent but not monovalent vaccine. The relative efficacy against rotavirus disease over the 2 years of observation was 40% (98.3% confidence interval, 7% to 62%) for the monovalent and 57% (98.3% confidence interval, 29% to 74%) for the tetravalent vaccine. In post hoc analyses, the relative efficacy against very severe rotavirus gastroenteritis was 73% and 82% for monovalent and tetravalent vaccine recipients, respectively. Also, a 67% and 78% reduction in medical visits for rotavirus gastroenteritis was observed. Both vaccines protected against disease caused by serotype 1 rotavirus, but only the tetravalent vaccine reduced the incidence of disease caused by non-serotype 1 rotavirus infection detected in the second season. It is unclear, however, whether this result represents serotype-specific protection or a difference in the duration of protection.
Vaccination with both vaccines was safe and significantly reduced the incidence of rotavirus gastroenteritis, but only the tetravalent vaccine provided protection against disease caused by non-serotype 1 rotaviruses during the second year of follow-up.
确定两种重组恒河猴轮状病毒疫苗在两个轮状病毒流行季节的安全性和相对有效性。
一项前瞻性、双盲、安慰剂对照试验。
美国的23个中心。
共招募了1006名年龄在4至26周的健康婴儿，其中898名接受了三剂疫苗或安慰剂。
通过比较每次接种疫苗后5天内发热、腹泻和/或呕吐的发生率来确定反应原性。在一部分受试者中检测了针对恒河猴轮状病毒和四种轮状病毒血清型的轮状病毒IgA和中和抗体。通过比较在两个轮状病毒流行季节接种三剂疫苗或安慰剂后轮状病毒胃肠炎的发生率来确定相对有效性。
不良反应轻微，仅限于接种第一剂四价疫苗而非单价疫苗后发热发生率有小幅但显著的增加。在两年的观察期内，单价疫苗对轮状病毒疾病的相对有效性为40%（98.3%置信区间，7%至62%），四价疫苗为57%（98.3%置信区间，29%至74%）。在事后分析中，单价和四价疫苗接种者对非常严重的轮状病毒胃肠炎的相对有效性分别为73%和82%。此外，观察到因轮状病毒胃肠炎就诊的次数分别减少了67%和78%。两种疫苗都能预防由1型血清型轮状病毒引起的疾病，但只有四价疫苗降低了第二季检测到的非1型血清型轮状病毒感染引起的疾病发生率。然而，尚不清楚这一结果是代表血清型特异性保护还是保护持续时间的差异。
两种疫苗接种均安全，且显著降低了轮状病毒胃肠炎的发生率，但只有四价疫苗在随访的第二年提供了针对非1型血清型轮状病毒引起疾病的保护。
