Safety, Immunogenicity, and Protective Efficacy of One and Three Doses of the Tetravalent Rhesus Rotavirus Vaccine in Infants in Lima, Peru
Open Access
- 1 August 1996
- journal article
- clinical trial
- Published by Oxford University Press (OUP) in The Journal of Infectious Diseases
- Vol. 174 (2) , 268-275
- https://doi.org/10.1093/infdis/174.2.268
Abstract
An oral rhesus-human rotavirus tetravalent (RRV-TV) vaccine (104 pfu of rhesus rotavirus [type G3]and of 3 human-rhesus reassortants [Gl, G2, and G4]) was evaluated in a field trial in Lima, Peru. At 2, 3, and 4 months of age, infants received either a dose of RRV-TV, an initial dose of vaccine followed by a dose of placebo at 3 and 4 months, or a dose of placebo. Rotavirus-specific IgA responses were detected by ELISA in 75% of the three-dose vaccine group, 59% of the one-dose vaccine group (P = .05), and 24% of the placebo group (P < .001): 64%, 48%, and 12% of each group, respectively, had a neutralizing antibody response to at least 1 serotype. Both one and three doses of vaccine failed to induce a significant level of protection against rotavirus diarrhea; however, they did provide some protection (range, 35%–66%) against more severe rotavirus diarrhea, especially for episodes caused by type G1.Keywords
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