Bresee J S, El Arifeen S, Azim T, Chakraborty J, Mounts A W, Podder G, Gentsch J R, Ward R L, Black R, Glass R I, Yunus M
Respiratory and Enteric Virus Branch, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
Pediatr Infect Dis J. 2001 Dec;20(12):1136-43. doi: 10.1097/00006454-200112000-00009.
Rotavirus is the most common cause of severe gastroenteritis among children worldwide.
To compare the safety, immunogenicity and shedding patterns of rhesus rotavirus (RRV)-tetravalent vaccine vs. placebo among infants in rural Bangladesh.
A double blinded, placebo-controlled trial was conducted in which infants (n = 120) were randomly assigned to receive three doses of either vaccine or placebo administered at approximately 6, 10 and 14 weeks of age together with routine immunizations. Data on possible adverse effects of vaccinations were collected daily for 7 days after each dose. Stool samples were collected after each dose, and serum samples were obtained before the first and after the third vaccination.
Fever (> or = 38 degrees C), as measured by study assistants, was noted more frequently among vaccinees (15%) than among placebo recipients (2%) during the 7 days after vaccination but was not reported more frequently by parents of vaccinees vs. placebo recipients. Overall 87% of vaccinees had an antibody response (measured by IgA or anti-RRV-neutralizing antibodies) after vaccination compared with 32% of placebo recipients. Rates of seroconversion were higher among subjects with lower levels of prevaccination antibodies and those who shed rotavirus after vaccination. Vaccine strain viruses were detected in stools from placebo vaccine recipients who had evidence of IgA seroconversion.
In this population RRV-tetravalent vaccine was comparably immunogenic and safe as in trials conducted in developed countries, where this vaccine has been proved effective in preventing severe rotavirus diarrhea. These data support continued evaluation of rotavirus vaccines in developing countries.
轮状病毒是全球儿童严重肠胃炎的最常见病因。
比较恒河猴轮状病毒（RRV）四价疫苗与安慰剂在孟加拉国农村婴儿中的安全性、免疫原性及病毒排出模式。
进行了一项双盲、安慰剂对照试验，120名婴儿被随机分配接受三剂疫苗或安慰剂，分别在约6、10和14周龄时与常规免疫一起接种。每次接种后7天每天收集疫苗接种可能产生的不良反应数据。每次接种后收集粪便样本，在首次接种前和第三次接种后采集血清样本。
研究助手测量发现，接种疫苗者在接种后7天内发热（≥38摄氏度）的情况比接受安慰剂者更频繁（分别为15%和2%），但疫苗接种者的父母报告发热的频率并不比安慰剂接受者更高。总体而言，87%的疫苗接种者接种后产生了抗体反应（通过IgA或抗RRV中和抗体测量），而安慰剂接受者中这一比例为32%。接种前抗体水平较低以及接种后排出轮状病毒的受试者血清转化率更高。在有IgA血清转化证据的安慰剂疫苗接受者的粪便中检测到了疫苗株病毒。
在这一人群中，RRV四价疫苗的免疫原性和安全性与在发达国家进行的试验相当，在发达国家该疫苗已被证明可有效预防严重的轮状病毒腹泻。这些数据支持在发展中国家继续评估轮状病毒疫苗。
