Safety and immunogenicity of live, attenuated human rotavirus vaccine 89-12

The safety and immunogenicity of an orally administered live human rotavirus vaccine candidate (89-12), attenuated by 33 passages in monkey kidney cells, were evaluated in placebo-controlled trails in adults, children and infants. This strain was selected because natural infections with 89-12-like rotaviruses, provided 100% protection over two yeats. The initial evaluations in adults, seropositive children and nine infants indicated that rite vaccine was safe. Two doses of vaccine (10(5) p.f.u. dose(-1)) ol placebo were then given to 42 infants, aged from 6 to 26 weeks, No significant difference ill sine effects was seen. Seroconversion was demonstrated in 19 Of 20 previously uninfected vaccine recipients, but greater than or equal to 4 fold rises in 89-12 neutralizing antibody titers were detected in only seven subjects. Intestinal IgA responses were detected in 15 subjects, This attenuated human? rotavirus was safe and immunogenic and should be further evaluated as a vaccine candidate. (C) 1998 Elsevier Science Ltd. All rights reserved.