TY - JOUR
T1 - Safety and immunogenicity of bovine rotavirus vaccine RIT 4237 in 3-month-old infants
AU - Maldonado, Y.
AU - Hestvik, L.
AU - Wilson, M.
AU - Townsend, T.
AU - O'Hare, J.
AU - Wee, S.
AU - Yolken, R.
N1 - Funding Information:
Rotaviruses are double-strained RNA viruses that have been identified as major etiologic agents of symptomatic gastroenteritis in infants and young children. ~. 2 Epidemiologic studies have documented that rotavirus infections account for up to one half of all pediatric hospital admissions because of acute gastroenteritis in developed countries and up to one million deaths annually in less developed areas of the world) -6 To date, therapeutic strategies for rotaviral diseases have been directed at oral Supported by Grant AM-33089 and Contract AI-52579 from the National Institutes of Health and by grants from Smith Kline and French and the Thrasher Research Fund. Dr. Maldonado is a recipient of a training grant from the Stetler Fund. Submitted for publication March 5, 1986; accepted July 8, 1986. Reprint requests: Yvonne Maldonado, M.D., The Johns Hopkins University School of Medicine, Department of Pediatrics, Division of Infectious Diseases, 600 N. Wolfe St., Baltimore, MD 21205.
PY - 1986/12
Y1 - 1986/12
N2 - To assess the safety and immunogenicity of bovine rotavirus vaccine, we administered attenuated strain RIT 4237 to 54 inner-city infants randomized to one of three groups in a double-blind fashion to receive a dose at 3 and 5 months of age of either placebo, vaccine virus at 107 TCID50/ml, or vaccine virus at 108 TCID50/ml. Vaccination began in early fall 1984, and continued through spring 1985. Forty-nine infants received one dose of vaccine or placebo; 43 received both doses of vaccine or placebo. At 2 and 3 months after vaccination, homologous geometric mean neutralizing antibody titers were significantly higher in children who received either dose of vaccine compared with placebo recipients. Cumulative seroconversion to bovine rotavirus after either dose of vaccine virus was 87% at 6 months of age. Seroconversion was significantly higher (P<0.01) in both vaccine groups compared with the placebo group. No ill effects were associated with vaccine administration. RIT 4237 vaccine appears to be safe and immunogenic when administered to young infants living in the United States.
AB - To assess the safety and immunogenicity of bovine rotavirus vaccine, we administered attenuated strain RIT 4237 to 54 inner-city infants randomized to one of three groups in a double-blind fashion to receive a dose at 3 and 5 months of age of either placebo, vaccine virus at 107 TCID50/ml, or vaccine virus at 108 TCID50/ml. Vaccination began in early fall 1984, and continued through spring 1985. Forty-nine infants received one dose of vaccine or placebo; 43 received both doses of vaccine or placebo. At 2 and 3 months after vaccination, homologous geometric mean neutralizing antibody titers were significantly higher in children who received either dose of vaccine compared with placebo recipients. Cumulative seroconversion to bovine rotavirus after either dose of vaccine virus was 87% at 6 months of age. Seroconversion was significantly higher (P<0.01) in both vaccine groups compared with the placebo group. No ill effects were associated with vaccine administration. RIT 4237 vaccine appears to be safe and immunogenic when administered to young infants living in the United States.
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U2 - 10.1016/S0022-3476(86)80271-2
DO - 10.1016/S0022-3476(86)80271-2
M3 - Article
C2 - 3537248
AN - SCOPUS:0023003420
SN - 0022-3476
VL - 109
SP - 931
EP - 935
JO - The Journal of pediatrics
JF - The Journal of pediatrics
IS - 6
ER -