Abstract
Rotavirus is a major worldwide cause of acute gastroenteritis in children. We recently evaluated a rhesus monkey rotavirus (RRV-1) which shares neutralization specificity with human sero-type 3, as a potential vaccine candidate. We administered RRV-1 (106 TCID50) or placebo orally to 40 adult volunteers who had low or undetectable levels of serum neutralizing antibody under double-blind conditions. Volunteers were evaluated daily for signs and symptoms of gastroenteritis, and stools were examined for RRV-1 by ELISA and tissue culture. Administration of RRV-1 did not induce illness. RRV-1 was shed in the stools of 11/21 (53%) vaccinees for 1 to 6 days without transmission of RRV-1 to other subjects, although one placebo recipient shed wild-type rotavirus from a community-acquired infection. Fourfold or greater serum neutralizing antibody rises to RRV-1 were noted in all vaccinees (21/21) and in 1/18 placebo recipients. Serum antibody rises were also demonstrated by immune adherence hemagglutination in 20/21 volunteers who received RRV-1 and in 1/18 who received placebo, and by complement fixation in 17/21 who received RRV-1 and 0/17 who received placebo. Transient asymptomatic serum ALT and AST rises were seen with similar frequencies in RRV-1 (3/21) and placebo (5/19) recipients. Thus, RRV-1 appears to be attenuated and highly immunogenic in young adults, and warrants additional study in children.
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