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| EVALUATION OF THE PROTECTIVE EFFICACY OF A SEROTYPE-1 BOVINE-HUMAN ROTAVIRUS REASSORTANT VACCINE IN INFANTS |
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| Author(s): TREANOR JJ, CLARK HF, PICHICHERO M, CHRISTY C, GOUVEA V, SHRAGER D, PALAZZO S, OFFIT P |
| Source: PEDIATRIC INFECTIOUS DISEASE JOURNAL Volume: 14 Issue: 4 Pages: 301-307 Published: APR 1995 |
| Times Cited: 36 References: 33 |
| Abstract: 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 tbe 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. |
| Document Type: Article |
| Language: English |
| Reprint Address: TREANOR, JJ (reprint author), UNIV ROCHESTER, SCH MED, DEPT MED, INFECT DIS UNIT, BOX 689, 601 ELMWOOD AVE, ROCHESTER, NY 14642 USA |
Addresses:
1. UNIV ROCHESTER, DEPT PEDIAT, ROCHESTER, NY 14642 USA
2. CHILDRENS HOSP PHILADELPHIA, INFECT DIS SECT, PHILADELPHIA, PA 19104 USA
3. US FDA, DIV MICROBIOL, WASHINGTON, DC 20204 USA |
| Publisher: WILLIAMS & WILKINS, 351 WEST CAMDEN ST, BALTIMORE, MD 21201-2436 |
| Subject Category: Immunology; Infectious Diseases; Pediatrics |
| IDS Number: QT556 |
| ISSN: 0891-3668 |
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| | | | | | | | | Record from Web of Science® | | | | | | | | | |