TY - JOUR
T1 - Efficacy and safety of high-dose rhesus-human reassortant rotavirus vaccine in Native American populations
AU - Santosham, M.
AU - Moulton, L. H.
AU - Reid, R.
AU - Croll, J.
AU - Weatherholt, R.
AU - Ward, R.
AU - Forro, J.
AU - Zito, E.
AU - Mack, M.
AU - Brenneman, G.
AU - Davidson, B. L.
N1 - Funding Information:
Supported by a grant from Wyeth-Ayerst Research.
PY - 1997
Y1 - 1997
N2 - Objectives: We compared the efficacy, safety, and immunogenicity of a rhesus rotavirus tetravalent vaccine (RRV-TV), a rhesus rotavirus monovalent (serotype 1) vaccine (RRV-S1), and placebo in healthy American Indian infants for two rotavirus seasons. Study design: Infants aged 6 to 24 weeks were enrolled in a randomized, double-blind efficacy study. Infants were orally administered RRV-TV (4 x 105 plaque-forming units per dose), RRV-S1 (4 x 105 plaque-forming units per dose), or placebo at 2, 4, and 6 months of age. Stools collected during episodes of gastroenteritis were tested for detection of rotavirus antigen. A total of 1185 infants received at least one dose of a study vaccine or placebo, and 1051 received all three doses according to the protocol. Results: During the first year of surveillance, the estimates of vaccine efficacy (with 95% confidence interval) for preventing rotaviral gastroenteritis were 50% (26, 67) for RRV-TV and 29% (-1, 50) for RRV-S1. In this population only 6% of rotaviral gastroenteritis episodes among placebo recipients were associated with type G1 disease. For severe disease the estimates of vaccine efficacy were higher: 69% (29, 88) for RRV-TV and 48% (- 4, 75) for RRV-S1. Conclusions: These data indicate that RRV-TV is moderately efficacious in preventing all episodes of gastroenteritis caused by rotavirus and is most efficacious against the severe disease characteristic of rotaviral illness.
AB - Objectives: We compared the efficacy, safety, and immunogenicity of a rhesus rotavirus tetravalent vaccine (RRV-TV), a rhesus rotavirus monovalent (serotype 1) vaccine (RRV-S1), and placebo in healthy American Indian infants for two rotavirus seasons. Study design: Infants aged 6 to 24 weeks were enrolled in a randomized, double-blind efficacy study. Infants were orally administered RRV-TV (4 x 105 plaque-forming units per dose), RRV-S1 (4 x 105 plaque-forming units per dose), or placebo at 2, 4, and 6 months of age. Stools collected during episodes of gastroenteritis were tested for detection of rotavirus antigen. A total of 1185 infants received at least one dose of a study vaccine or placebo, and 1051 received all three doses according to the protocol. Results: During the first year of surveillance, the estimates of vaccine efficacy (with 95% confidence interval) for preventing rotaviral gastroenteritis were 50% (26, 67) for RRV-TV and 29% (-1, 50) for RRV-S1. In this population only 6% of rotaviral gastroenteritis episodes among placebo recipients were associated with type G1 disease. For severe disease the estimates of vaccine efficacy were higher: 69% (29, 88) for RRV-TV and 48% (- 4, 75) for RRV-S1. Conclusions: These data indicate that RRV-TV is moderately efficacious in preventing all episodes of gastroenteritis caused by rotavirus and is most efficacious against the severe disease characteristic of rotaviral illness.
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U2 - 10.1016/S0022-3476(97)70076-3
DO - 10.1016/S0022-3476(97)70076-3
M3 - Article
C2 - 9386673
AN - SCOPUS:0031468383
SN - 0022-3476
VL - 131
SP - 632
EP - 638
JO - Journal of Pediatrics
JF - Journal of Pediatrics
IS - 4
ER -