Escobar Castro H, Perdomo Giraldi M, Tamáriz-Martel Moreno A, Suárez Cortina L
Unidad de Gastroenterología, Hospital Ramón y Cajal, Madrid.
An Esp Pediatr. 1988 Jun;28(6):527-9.
A randomized, double-blind trial was performed to assess serological response and clinical protection for acute gastroenteritis due to rotavirus in 103 children aged 6 to 18 months, after a single dose of RIT 4237 live attenuated bovine rotavirus vaccine or placebo. Seroconversion, determined by enzyme-linked immunoabsorbent assay (ELISA), was significantly greater in initially seronegative vaccines compared with control group (p less than 0.0001); clinical protection rate was low in this study group and it is therefore concluded that seroconversion by itself is not sufficient to measure vaccine efficacy.
对103名6至18个月大的儿童进行了一项随机双盲试验,以评估单剂量RIT 4237减毒活牛轮状病毒疫苗或安慰剂对轮状病毒引起的急性胃肠炎的血清学反应和临床保护作用。通过酶联免疫吸附测定(ELISA)确定,最初血清阴性的疫苗组血清转化率显著高于对照组(p小于0.0001);该研究组的临床保护率较低,因此得出结论,血清转化本身不足以衡量疫苗效力。