Safety, immunogenicity, and protective efficacy of one and three doses of the tetravalent rhesus rotavirus vaccine in infants in Lima, Peru
Safety, immunogenicity, and protective efficacy of one and three doses of the tetravalent rhesus rotavirus vaccine in infants in Lima, Peru
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DOI：
10.1093/infdis/174.2.268
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发表时间：
1996-08-01
影响因子：
6.4
通讯作者：
Davidson, BL
中科院分区：
文献类型：
--
作者：
Lanata, CF;Midthun, K;Davidson, BL
在秘鲁利马的现场试验中评估了口服恒河猴-人轮状病毒四价 (RRV-TV) 疫苗（10(4) pfu 恒河猴轮状病毒 [G3 型] 和 3 种人-恒河猴重配体 [G1、G2 和 G4]）。在 2、3 和 4 个月大时，婴儿接受一剂 RRV-TV、初始剂量疫苗，然后在 3 和 4 个月大时接受一剂安慰剂，或一剂安慰剂。通过 ELISA，在三剂疫苗组中 75%、一剂疫苗组中 59% (P = .05) 和安慰剂组中 24% (P < .001) 检测到轮状病毒特异性 IgA 反应：每组中分别有 64%、48% 和 12% 对至少 1 种血清型产生中和抗体反应。一剂和三剂疫苗均未能产生显着水平的针对轮状病毒腹泻的保护作用；然而，它们确实提供了一些针对更严重的轮状病毒腹泻的保护（范围为 35%-66%），特别是针对 G1 型引起的腹泻。
An oral rhesus-human rotavirus tetravalent (RRV-TV) vaccine (10(4) pfu of rhesus rotavirus [type G3] and of 3 human-rhesus reassortants [G1, G2, and G4]) was evaluated in a field trial in Lima, Peru. At 2, 3, and 4 months of age, infants received either a dose of RRV-TV, an initial dose of vaccine followed by a dose of placebo at 3 and 4 months, or a dose of placebo. Rotavirus-specific IgA responses were detected by ELISA in 75% of the three-dose vaccine group, 59% of the one-dose vaccine group (P = .05), and 24% of the placebo group (P < .001): 64%, 48%, and 12% of each group, respectively, had a neutralizing antibody response to at least 1 serotype. Both one and three doses of vaccine failed to induce a significant level of protection against rotavirus diarrhea; however, they did provide some protection (range, 35%-66%) against more severe rotavirus diarrhea, especially for episodes caused by type G1.