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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
4
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pubmed:dateCreated |
1995-8-7
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pubmed:abstractText |
The objective of this study was to evaluate the efficacy of a live, attenuated bovine (strain WC3) x human (strain WI79, serotype G1) rotavirus reassortant (WI79-9) virus vaccine for prevention of symptomatic rotavirus gastroenteritis in infants. The study was a prospective, randomized, double-blind, placebo-controlled trial, conducted over a single rotavirus season in 325 infants who were 2 to 8 months old at enrollment. Subjects were randomized to receive either placebo or WI79-9 virus vaccine at 10(7.3) plaque-forming units in three oral doses each separated by 2 months. Subjects were followed for 7 days after each dose for occurrence of adverse events and during the subsequent winter for development of rotavirus gastroenteritis. Administration of WI79-9 virus vaccine was well-tolerated, and the rates of low grade fever after each dose were no higher in vaccine recipients (8 to 21%) than in placebo recipients (14 to 19%). The protective efficacy of the WI79-9 vaccine during a subsequent epidemic of predominantly serotype G1 rotavirus was 87.0% (95% confidence limits, 62.6 to 95.5%) against relatively severe rotavirus gastroenteritis (rotavirus gastroenteritis with a clinical severity score of > 8) and was 64.1% (95% confidence limits 35.9 to 79.9%) against all symptomatic rotavirus episodes. The WI79-9 vaccine was safe and effective in prevention of homotypic human rotavirus infection in infants. Further studies of reassortant vaccines based on the bovine WC3 rotavirus should be performed.
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pubmed:grant | |
pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
|
pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
Apr
|
pubmed:issn |
0891-3668
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pubmed:author | |
pubmed:issnType |
Print
|
pubmed:volume |
14
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
301-7
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pubmed:dateRevised |
2007-11-14
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pubmed:meshHeading |
pubmed-meshheading:7603812-Confidence Intervals,
pubmed-meshheading:7603812-Double-Blind Method,
pubmed-meshheading:7603812-Gastroenteritis,
pubmed-meshheading:7603812-Humans,
pubmed-meshheading:7603812-Infant,
pubmed-meshheading:7603812-Prospective Studies,
pubmed-meshheading:7603812-Rotavirus,
pubmed-meshheading:7603812-Rotavirus Infections,
pubmed-meshheading:7603812-Rotavirus Vaccines,
pubmed-meshheading:7603812-Serotyping,
pubmed-meshheading:7603812-Vaccination,
pubmed-meshheading:7603812-Vaccines, Attenuated,
pubmed-meshheading:7603812-Viral Vaccines
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pubmed:year |
1995
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pubmed:articleTitle |
Evaluation of the protective efficacy of a serotype 1 bovine-human rotavirus reassortant vaccine in infants.
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pubmed:affiliation |
Department of Medicine, University of Rochester, NY, USA.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Research Support, U.S. Gov't, P.H.S.,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't
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