摘要
目的:研究包含人-牛(WC3)重组轮状病毒血清型G1、G2、G3和P1a的活的四价轮状病毒疫苗(QRV)的安全性、有效性和免疫原性。研究设计:这是一个随机、双盲、空白对照实验。1993-1994年,在美国10所研究机构,有439名健康的2-6个月婴儿参与了该实验,大约在8周内共口服3副QRV或安慰剂。结果:该疫苗获得普遍的认可,没有严重的疫苗相关性副作用的报道。
Objectives To investigate safety, efficacy, and immuno-genicity of live quadrivalent rotavirus vaccine (QRV) containing humanbovine (WC3) reassortant rotavirus serotypes G1, G2, G3, and P1 a. Study design This was a randomized, double-blinded, placebo-controlled trial. During 1993 to 1994, at 10 US study sites, 439 healthy infants - 2 to 6 months of age, were enrolled to receive 3 doses of oral QRV or placebo at approximately 8 - week intervals. Results The vaccine was generally well tolerated; no serious vaccine-related adverse experiences were reported. Risk differences and 95% confidence intervals suggested no differences between vaccine and placebo recipients in the incidences of fever, irritability, vomiting, or diarrhea during the 14 days after any dose. QRV was 74. 6% efficacious (95% CI: 49. 5%, 88. 3% ) in preventing rotavirus acute gastroenteritis (AGE), regardless of severity and 100% efficacious (95% CI: 43. 5%, 100% ) in preventing severe rotavirus AGE through one rotavirus season. Serotype Gl was identified in most infants with rotavirus AGE. A 3≥ 3 - fold rise in serum neutralizing antibody to Gl was observed in 57% (45/79) of vacci- nees. A ≥ 3 - fold rise in serum anti-rotavirus IgA and fecal anti-rotavirus IgA was observed in 88% (162/185) and 65% (104/159) of vaccinees, respectively. Conclusions QRV was generally well tolerated, immungenic, and highly effective against rotavirus gastroenteritis.
