Vesikari Timo, Matson David O, Dennehy Penelope, Van Damme Pierre, Santosham Mathuram, Rodriguez Zoe, Dallas Michael J, Heyse Joseph F, Goveia Michelle G, Black Steven B, Shinefield Henry R, Christie Celia D C, Ylitalo Samuli, Itzler Robbin F, Coia Michele L, Onorato Matthew T, Adeyi Ben A, Marshall Gary S, Gothefors Leif, Campens Dirk, Karvonen Aino, Watt James P, O'Brien Katherine L, DiNubile Mark J, Clark H Fred, Boslego John W, Offit Paul A, Heaton Penny M
University of Tampere Medical School, Tampere, Finland.
N Engl J Med. 2006 Jan 5;354(1):23-33. doi: 10.1056/NEJMoa052664.
Rotavirus is a leading cause of childhood gastroenteritis and death worldwide.
We studied healthy infants approximately 6 to 12 weeks old who were randomly assigned to receive three oral doses of live pentavalent human-bovine (WC3 strain) reassortant rotavirus vaccine containing human serotypes G1, G2, G3, G4, and P[8] or placebo at 4-to-10-week intervals in a blinded fashion. Active surveillance was used to identify subjects with serious adverse and other events.
The 34,035 infants in the vaccine group and 34,003 in the placebo group were monitored for serious adverse events. Intussusception occurred in 12 vaccine recipients and 15 placebo recipients within one year after the first dose including six vaccine recipients and five placebo recipients within 42 days after any dose (relative risk, 1.6; 95 percent confidence interval, 0.4 to 6.4). The vaccine reduced hospitalizations and emergency department visits related to G1-G4 rotavirus gastroenteritis occurring 14 or more days after the third dose by 94.5 percent (95 percent confidence interval, 91.2 to 96.6 percent). In a nested substudy, efficacy against any G1-G4 rotavirus gastroenteritis through the first full rotavirus season after vaccination was 74.0 percent (95 percent confidence interval, 66.8 to 79.9 percent); efficacy against severe gastroenteritis was 98.0 percent (95 percent confidence interval, 88.3 to 100 percent). The vaccine reduced clinic visits for G1-G4 rotavirus gastroenteritis by 86.0 percent (95 percent confidence interval, 73.9 to 92.5 percent).
This vaccine was efficacious in preventing rotavirus gastroenteritis, decreasing severe disease and health care contacts. The risk of intussusception was similar in vaccine and placebo recipients. (ClinicalTrials.gov number, NCT00090233.)
轮状病毒是全球儿童肠胃炎及死亡的主要病因。
我们研究了年龄约6至12周的健康婴儿,这些婴儿被随机分配,以盲法每4至10周间隔口服三剂含人血清型G1、G2、G3、G4和P[8]的五价人-牛(WC3株)重组轮状病毒疫苗或安慰剂。采用主动监测来识别有严重不良事件及其他事件的受试者。
对疫苗组的34,035名婴儿和安慰剂组的34,003名婴儿进行了严重不良事件监测。在首剂接种后1年内,12名疫苗接种者和15名安慰剂接种者发生肠套叠,包括在任何一剂接种后42天内有6名疫苗接种者和5名安慰剂接种者(相对风险,1.6;95%置信区间,0.4至6.4)。该疫苗使第三剂接种14天或更长时间后发生的与G1-G4轮状病毒肠胃炎相关的住院和急诊就诊减少了94.5%(95%置信区间,91.2至96.6%)。在一项嵌套子研究中,接种疫苗后首个完整轮状病毒季节对任何G1-G4轮状病毒肠胃炎的疗效为74.0%(95%置信区间,66.8至79.9%);对严重肠胃炎的疗效为98.0%(95%置信区间,88.3至100%)。该疫苗使G1-G4轮状病毒肠胃炎的门诊就诊减少了86.0%(95%置信区间,73.9至92.5%)。
这种疫苗在预防轮状病毒肠胃炎、减少严重疾病及医疗接触方面有效。疫苗接种者和安慰剂接种者发生肠套叠的风险相似。(ClinicalTrials.gov编号,NCT00090233。)