Clark H Fred, Offit Paul A, Plotkin Stanley A, Heaton Penny M
Division of Infectious Diseases, ARC 1202, Children's Hospital of Philadelphia and University of Pennsylvania School of Medicine, Philadelphia, 19104, USA.
Pediatr Infect Dis J. 2006 Jul;25(7):577-83. doi: 10.1097/01.inf.0000220283.58039.b6.
Infantile gastroenteritis caused by human rotaviruses is a prevalent disease throughout the world, causing dehydration and hospitalization in all countries. In developing countries, it is associated with a high mortality. A licensed vaccine against rotavirus was withdrawn because of a causal association with intussusception. A new vaccine has been developed and is a candidate for licensure.
To recount the early development and recent demonstration of the safety and efficacy of the new vaccine. A bovine rotavirus attenuated for humans was isolated and reassorted with human rotaviruses of serotypes G1-4 and P1 to create a pentavalent vaccine. Multiple placebo-controlled clinical trials, including one involving approximately 70,000 infants, were conducted in multiple developed countries.
The pentavalent vaccine was well tolerated by infants less than 8 months of age, and the incidence of intussusception was similar among vaccine and placebo recipients. More than 90% of infants had a significant rise in serum antirotavirus IgA titer after 3 doses. Efficacy of 95% against severe disease causing hospitalization or emergency care was demonstrated, and pentavalent vaccine prevented 74% of all rotavirus disease.
If widely used, pentavalent vaccine would control rotavirus disease in the United States and other developed countries and could also have a major effect in developing countries.
人类轮状病毒引起的婴儿肠胃炎是一种全球普遍流行的疾病，在所有国家都会导致脱水和住院治疗。在发展中国家，它与高死亡率相关。一种已获许可的轮状病毒疫苗因与肠套叠存在因果关联而被撤回。一种新疫苗已研发出来，正在申请许可。
回顾新疫苗的早期研发情况以及近期关于其安全性和有效性的论证。分离出一种对人类减毒的牛轮状病毒，并与G1 - 4血清型和P1型人类轮状病毒进行重配，以制备一种五价疫苗。在多个发达国家开展了多项安慰剂对照临床试验，其中一项涉及约70000名婴儿。
五价疫苗在8个月以下婴儿中耐受性良好，疫苗接种者和安慰剂接受者的肠套叠发病率相似。超过90%的婴儿在接种3剂后血清抗轮状病毒IgA滴度显著升高。已证明该疫苗对导致住院或急诊治疗的严重疾病的有效率为95%，五价疫苗预防了74%的所有轮状病毒疾病。
如果广泛使用，五价疫苗将在美国和其他发达国家控制轮状病毒疾病，并且在发展中国家也可能产生重大影响。
