Clinical trials of live oral rotavirus vaccines: the Finnish experience

T Vesikari - Vaccine, 1993 - Elsevier
T Vesikari
Vaccine, 1993Elsevier
Live oral candidate rotavirus vaccines of bovine (RIT 4237) or rhesus (RRV-1) origin and
reassortants of RRV-1 expressing human serotype 1 (DxRRV) or serotype 2 (DS1xRRV)
VP7 protein were evaluated for clinical efficacy in young children in successive trials from
1983 to 1989. In each study, the vaccinations were given before a rotavirus epidemic
season and the follow-up of vaccinees covered two rotavirus epidemic seasons lasting up to
2–3 years of age. Serotype 1 rotavirus was predominant in each season. Protection rates …
Abstract
Live oral candidate rotavirus vaccines of bovine (RIT 4237) or rhesus (RRV-1) origin and reassortants of RRV-1 expressing human serotype 1 (DxRRV) or serotype 2 (DS1xRRV) VP7 protein were evaluated for clinical efficacy in young children in successive trials from 1983 to 1989. In each study, the vaccinations were given before a rotavirus epidemic season and the follow-up of vaccinees covered two rotavirus epidemic seasons lasting up to 2–3 years of age. Serotype 1 rotavirus was predominant in each season. Protection rates against all rotavirus-associated diarrhoea ranged from 0 to 67% but were higher, up to 100%, against more severe rotavirus disease. All tested vaccines also showed efficacy for diarrhoea not apparently associated with rotavirus; therefore the clinical benefit of the vaccinations was greater than could be deduced from efficacy rates for rotavirus-associated diarrhoea alone. Each of the candidate vaccines could significantly reduce severe diarrhoea in Finnish children in the first 2 to 3 years of life. For optimal efficacy, the vaccines should be administered in the autumn before the regular epidemic season of rotavirus.
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