Ward Richard L, Bernstein David I, Smith Vicki E, Sander Donna S, Shaw Alan, Eiden Joseph J, Heaton Penny, Offit Paul A, Clark H Fred
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, USA.
J Infect Dis. 2004 Jun 15;189(12):2290-3. doi: 10.1086/421248. Epub 2004 May 25.
A quadrivalent precursor to the pentavalent rotavirus vaccine candidate RotaTeq was evaluated in a 3-dose, 439-subject study. To determine immunogenicity, the quantity of rotavirus immunoglobulin A (IgA) in stool specimens obtained, at 1 of 10 study sites, from 37 placebo and 37 vaccine recipients was measured. None of the placebo recipients showed a clinically important (>/=3-fold) increase in stool rotavirus IgA, whereas 31 vaccine recipients showed an increase after at least 1 dose of vaccine. In total, 16, 19, and 15 vaccine recipients had increases after 1, 2, and 3 doses, respectively, indicating that a 3-dose regimen increased the immune response elicited by this vaccine.
在一项有439名受试者参与的3剂次研究中，对五价轮状病毒候选疫苗RotaTeq的四价前体进行了评估。为确定免疫原性，在10个研究地点之一，对37名安慰剂接受者和37名疫苗接受者的粪便样本中轮状病毒免疫球蛋白A（IgA）的含量进行了测量。安慰剂接受者中无人出现粪便轮状病毒IgA临床上有意义的（≥3倍）增加，而31名疫苗接受者在至少接种1剂疫苗后出现了增加。总共有16名、19名和15名疫苗接受者分别在接种1剂、2剂和3剂后出现增加，这表明3剂次接种方案增强了该疫苗引发的免疫反应。
