Libster Romina, McNeal Monica, Walter Emmanuel B, Shane Andi L, Winokur Patricia, Cress Gretchen, Berry Andrea A, Kotloff Karen L, Sarpong Kwabena, Turley Christine B, Harrison Christopher J, Pahud Barbara A, Marbin Jyothi, Dunn John, El-Khorazaty Jill, Barrett Jill, Edwards Kathryn M
Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University School of Medicine, Nashville, Tennessee; Fundación INFANT, CABA, Argentina; National Scientific and Technical Research Council (CONICET), CABA, Argentina;
Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio;
Pediatrics. 2016 Feb;137(2):e20152603. doi: 10.1542/peds.2015-2603. Epub 2016 Jan 28.
Although both licensed rotavirus vaccines are safe and effective, it is often not possible to complete the schedule by using the same vaccine formulation. The goal of this study was to investigate the noninferiority of the immune responses to the 2 licensed rotavirus vaccines when administered as a mixed schedule compared with administering a single vaccine formulation alone.
Randomized, multicenter, open-label study. Healthy infants (6-14 weeks of age) were randomized to receive rotavirus vaccines in 1 of 5 different schedules (2 using a single vaccine for all doses, and 3 using mixed schedules). The group receiving only the monovalent rotavirus vaccine received 2 doses of vaccine and the other 4 groups received 3 doses of vaccine. Serum for immunogenicity testing was obtained 1 month after the last vaccine dose and the proportion of seropositive children (rotavirus immunoglobulin A ≥20 U/mL) were compared in all the vaccine groups.
Between March 2011 and September 2013, 1393 children were enrolled and randomized. Immune responses to all the sequential mixed vaccine schedules were shown to be noninferior when compared with the 2 single vaccine reference groups. The proportion of children seropositive to at least 1 vaccine antigen at 1 month after vaccination ranged from 77% to 96%, and was not significantly different among all the study groups. All schedules were well tolerated.
Mixed schedules are safe and induced comparable immune responses when compared with the licensed rotavirus vaccines given alone.
尽管两种获得许可的轮状病毒疫苗都是安全有效的，但通常无法使用相同的疫苗配方完成接种程序。本研究的目的是调查两种获得许可的轮状病毒疫苗按混合接种程序接种时与单独使用单一疫苗配方接种相比免疫反应的非劣效性。
随机、多中心、开放标签研究。健康婴儿（6至14周龄）被随机分配接受5种不同接种程序之一的轮状病毒疫苗（2种程序所有剂量均使用单一疫苗，3种程序使用混合接种程序）。仅接受单价轮状病毒疫苗的组接种2剂疫苗，其他4组接种3剂疫苗。在最后一剂疫苗接种后1个月采集用于免疫原性检测的血清，并比较所有疫苗组中血清阳性儿童（轮状病毒免疫球蛋白A≥20 U/mL）的比例。
2011年3月至2013年9月，1393名儿童入组并被随机分配。与2个单一疫苗参考组相比，所有连续混合疫苗接种程序的免疫反应均显示为非劣效。接种疫苗后1个月时对至少1种疫苗抗原血清阳性的儿童比例在77%至96%之间，且在所有研究组之间无显著差异。所有接种程序耐受性良好。
与单独使用获得许可的轮状病毒疫苗相比，混合接种程序是安全的且能诱导相当的免疫反应。
