Abstract
Live attenuated rhesus monkey rotavirus (RRV-1), cross-reactive with human serotype 3, was evaluated for irrmunogenicity and safety in 6 month-old children. A 1:10 diluted vaccine bulk (approximately 106/ml) given orally induced an antibody response in 21/24 (88%) of the children with high antibody titers. A febrile reaction (over 38°) on days 3 and 4 was seen in 60% of the children, and 20% of the vaccine recipients had some watery stools. It was concluded that the RRV-1 vaccine at the given dose was highly immunogenic but unacceptably reactogenic in the target population (Vesikari et al, J Infect Dis, in press).
A second trial of the RRV-1 vaccine, diluted 1:100 from the bulk (approximately 105/ml) was initiated in December 1985 in 2 to 5 month-old children, who are likely to have transplacentally acquired rotavirus antibody. Preliminary analysis of 59 vaccinees indicated that about 15% had a febrile reaction (over 38°) on days 3 and 4. The study will continue as a placebo-controlled protection study over the current rotavirus season until June 1986.
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Vesikari, T., Pautanen, T. & Kapikian, A. CLINICAL TRIALS OF RHESUS ROTAVIRUS (REV-1) VACCINE IN YOUNG INFANTS. Pediatr Res 20, 692 (1986). https://doi.org/10.1203/00006450-198607000-00039
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DOI: https://doi.org/10.1203/00006450-198607000-00039