Flores J, Daoud G, Daoud N, Puig M, Martinez M, Perez-Schael I, Shaw R, Greenberg H B, Midthun K, Kapikian A Z
Laboratory of Infectious Diseases, National Institutes of Health, Bethesda, MD 20892.
Pediatr Infect Dis J. 1988 Nov;7(11):776-80. doi: 10.1097/00006454-198811000-00006.
The reactogenicity and antigenicity of the rhesus rotavirus vaccine, strain MMU18006, developed at the Laboratory of Infectious Diseases (National Institute of Allergy and Infectious Diseases, National Institutes of Health) were examined in a double blind, placebo-controlled study of 40 newborn infants in Caracas, Venezuela. The children were observed for the first few days after birth in the hospital nursery and by home visits for 10 days after vaccination to detect any adverse reactions. No reactions could be attributed to the vaccine. Serologic responses to the vaccine were evaluated in paired sera obtained at birth (cord blood) and 4 weeks after vaccination. Serologic responses to the vaccine were not observed by complement fixation, neutralization or a rhesus rotavirus VP7 epitope-specific competition assay. However, such responses were found in 9 of 14 tested infants by an immunoglobulin A-specific enzyme-linked immunosorbent assay. Seventeen of the 20 vaccinees also shed rhesus rotavirus vaccine in stool during the postvaccination period.
美国国立卫生研究院国家过敏和传染病研究所传染病实验室研发的恒河猴轮状病毒疫苗MMU18006的反应原性和抗原性，在委内瑞拉加拉加斯对40名新生儿进行的一项双盲、安慰剂对照研究中进行了检测。这些儿童在出生后的头几天在医院托儿所接受观察，并在接种疫苗后进行10天的家访，以检测任何不良反应。没有反应可归因于疫苗。通过出生时（脐血）和接种疫苗后4周获得的配对血清评估对疫苗的血清学反应。通过补体结合、中和或恒河猴轮状病毒VP7表位特异性竞争试验未观察到对疫苗的血清学反应。然而，通过免疫球蛋白A特异性酶联免疫吸附试验，在14名受试婴儿中的9名中发现了此类反应。20名接种疫苗者中有17名在接种疫苗后的时期内粪便中也排出了恒河猴轮状病毒疫苗。
