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首页> 外文期刊>Journal of Clinical Microbiology >Reactogenicity and immunogenicity of a high-titer rhesus rotavirus-based quadrivalent rotavirus vaccine.
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Reactogenicity and immunogenicity of a high-titer rhesus rotavirus-based quadrivalent rotavirus vaccine.

机译：高滴度恒河猴轮状病毒四价轮状病毒疫苗的反应原性和免疫原性。

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We evaluated the reactogenicity and antigenicity of a quadrivalent rotavirus vaccine composed of serotype 3 rhesus rotavirus (RRV) and three single-gene-substitution reassortants of RRV and human strain D (D x RRV, serotype 1), DS1 (DS1 x RRV, serotype 2), or ST3 (ST3 x RRV, serotype 4) in a double-masked study with 302 infants in Caracas, Venezuela. Three doses of the quadrivalent vaccine composed of either 10(5) PFU (low titer) or 10(6) PFU (high titer) of each component were administered to 99 and 101 infants, respectively, at 4-week intervals starting at the second month of age; 102 infants received a placebo. Postvaccination reactions were monitored by home visits every other day during the week postvaccination. The vaccine was associated with the occurrence of mild, short-lived febrile episodes in 26 and 23% of the recipients after the first doses of high- or low-titer vaccine, respectively, in comparison with 13% of the infants receiving the placebo. Febrile reactions occurred less frequently in vaccinees after the second or third dose than after the initial dose. The vaccine was not significantly associated with diarrhea or any additional symptom or sign. Serum specimens obtained shortly before the first, 4 weeks after the first, and 4 weeks after the third dose of vaccine or placebo were tested by an immunoglobulin A enzyme-linked immunosorbent assay and by neutralization assays. Seroresponses occurred significantly more often after 3 doses than after a single dose of either vaccine. Immunoglobulin A responses were observed in 80 and 79% of the infants after 3 doses of high- or low-titer vaccine, respectively. Most of the infants tested developed a neutralization response to RRV after 3 doses of the high- (90%) or low-(88%) titer vaccine. Neutralization response rates to human rotavirus serotypes 1 to 4 after 3 doses were similar in both vaccine and 87 of 90 receiving the high-titer vaccine developed seroresponses, as detected by any of the assays employed. The study indicates that 3 doses of quadrivalent vaccine at a titer of 10(6) PFU of each component offered no advantage over the lower-titer preparation for use in efficacy trials.
机译：我们评估了由血清型3恒河猴轮状病毒（RRV）和RRV和人类品系D（D x RRV，血清型1），DS1（DS1 x RRV，血清型）的三个单基因替代重配体组成的四价轮状病毒疫苗的反应原性和抗原性2）或ST3（ST3 x RRV，血清型4）在委内瑞拉加拉加斯对302名婴儿进行的双重掩盖研究中。从第二次接种开始，每隔4周分别给99和101名婴儿接种三剂分别由10（5）PFU（低滴度）或10（6）PFU（高滴度）组成的四价疫苗。月龄; 102名婴儿接受了安慰剂。在疫苗接种后的一周内，每隔一天通过家访来监测疫苗接种后的反应。分别与第一次和第二次接受高滴度或低滴度疫苗的接种者中的26％和23％的接受者发生轻度，短暂的高热发作有关，而接受安慰剂的婴儿为13％。在第二次或第三次接种后，疫苗接种者发生发热反应的频率要低于初始剂量后。疫苗与腹泻或任何其他症状或体征无明显关联。通过免疫球蛋白A酶联免疫吸附测定和中和测定来测试在第一次或第三次接种疫苗或安慰剂后不久，4周和4周后不久获得的血清标本。 3剂疫苗后血清反应显着高于单剂两种疫苗。 3剂高滴度或低滴度疫苗接种后，分别在80％和79％的婴儿中观察到免疫球蛋白A反应。接受3剂高（90％）或低（88％）效价疫苗后，大多数接受测试的婴儿对RRV产生中和反应。 3种剂量后，对人轮状病毒血清型1-4的中和反应率在两种疫苗中均相似，接受高滴度疫苗的90人中有87人出现血清反应，这可通过所采用的任何分析方法进行检测。该研究表明，每种成分的效价为10（6）PFU的3剂四价疫苗与用于疗效试验的低滴度制剂相比没有优势。

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