WC3 rotavirus vaccine or a placebo preparation was administered to 104 infants aged 3-12 months from Sept. 1985 to Jan. 1986 in a suburban Phila. middle class population. Infants were given a single dose of WC3 vaccine (107.3 pfu) or placebo and were monitored daily for one week for vaccine sequelae. Active surveillance for rotavirus diarrhea was performed until June, 1986. Sequelae observed during 7 days post vaccination for vaccine (V) and placebo (P) groups were: loose stools: 12%V, 9%P; vomiting: 10%V, 6%P; fever (≥100.6°): 16%V, 11%P; irritability: 41%V, 44%P; the observed differences were not statistically significant. Rotavirus-associated diarrhea occurred between Jan. and May, 1986 in 14/55 placebo recipients and 3/49 vaccinees (protection rate = 76%, p = <0.02). Clinical scoring of gastroenteritis (GE) revealed an incidence of moderate to severe rotavirus disease of 11/55 in (P) recipients and 0/49 in (V) (protection = 100%, p = <0.001). A rotavirus strain that was isolated and identified as serotype 1 was associated with 14/17 cases of rotavirus diarrhea. Preliminary serological data suggests that serotype 1 or serotype 3 rotavirus infection also occurred in approximately 20% of infants in whom rotavirus GE was not detected, in both vaccine and placebo groups. The results suggest that WC3 vaccine protects against severe rotavirus disease and may also protect against rotavirus infection.
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Clark, H., Borian, F., Bell, L. et al. PROTECTION AFFORDED BY WC3 ROTAVIRUS VACCINE AGAINST NATURAL (PREDOMINANTLY SEROTYPE 1) ROTAVIRUS INFECTION IN A PLACEBO-BLINDED EFFICACY TRIAL. Pediatr Res 21, 323 (1987). https://doi.org/10.1203/00006450-198704010-00935
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