TY - JOUR
T1 - Safety and immunogenicity of live attenuated quadrivalent human-bovine (UK) reassortant rotavirus vaccine administered with childhood vaccines to infants
AU - Clements-Mann, Mary Lou
AU - Dudas, Robert
AU - Hoshino, Yasutaka
AU - Nehring, Pamela
AU - Sperber, Ellen
AU - Wagner, Mariam
AU - Stephens, Ina
AU - Karron, Ruth
AU - Deforest, Adamadie
AU - Kapikian, Albert Z.
N1 - Funding Information:
We thank Dr Xiao-Yi Yan at the National Institute of Allergy and Infectious Diseases for technical assistance; Dr Stephen Lambert, Dr Mark Pallansch, Silvia Penaranda, Berhane Beyene, and William Brisbay, at the Centers for Disease Control and Prevention; Dr Alicia Tortu at St. Christopher's Hospital for Children; and Dr Joel Ward and Swei-Ju Chang at UCLA Center for Vaccine Research, for serologic studies; and Romero Paredes, Vicki Hodgins, Barbara Burns, Roberta Casey, and Anna Speaks at the Johns Hopkins University Center for Immunization Research for clinical assistance with these studies. We also thank the staff and following persons in the pediatric practices for help in recruitment: Drs Valorie Anlage, Stephen Brown, Ann Werner, Edward Padow, Albert Modlin, and James Kalliongis of A.J. Modlin, M.D. and E.M. Padow, M.D., P.A.; Dr Frank Israel of Pediatrics at Chartley, P.A.; and Drs Carole Parnes, Michael May, Erica Sibinga, and Inas Anderson of Parnes and May. We are grateful to Alice Brogden for manuscript preparation and Dr Robert Chanock for reviewing the manuscript. Source of financial support: National Istitutes of Health contract NO1-AI-15095.
Copyright:
Copyright 2010 Elsevier B.V., All rights reserved.
PY - 2001/9/14
Y1 - 2001/9/14
N2 - The safety and immunogenicity of an orally administered, live rotavirus vaccine comprised of four strains, each with a titer of 105.3 or 105.8 pfu, and each having 10 genes from the UK bovine strain and the VP7 gene from human rotavirus serotype 1, 2, 3, or 4, were evaluated in adults, young children and infants in randomized, double-blind phase 1 trials. Three doses of rotavirus vaccine or placebo given with childhood immunizations to infants at 2, 4, and 6 months of age were well tolerated and did not inhibit antibody responses to childhood vaccines which included DTP, Hib, hepatitis B and OPV. Serum rotavirus antibody responses were detected in 12 of 20 infants after 1 dose, and in 19/19 of the vaccinees after three doses. Neutralizing antibody responses were detected more often against the bovine rotavirus UK strain (95%) than to human rotavirus VP7 serotypes 1 (37%), 2 (32%), 3 (32%) or 4 (32%). The efficacy of this quadrivalent rotavirus vaccine needs to be evaluated further.
AB - The safety and immunogenicity of an orally administered, live rotavirus vaccine comprised of four strains, each with a titer of 105.3 or 105.8 pfu, and each having 10 genes from the UK bovine strain and the VP7 gene from human rotavirus serotype 1, 2, 3, or 4, were evaluated in adults, young children and infants in randomized, double-blind phase 1 trials. Three doses of rotavirus vaccine or placebo given with childhood immunizations to infants at 2, 4, and 6 months of age were well tolerated and did not inhibit antibody responses to childhood vaccines which included DTP, Hib, hepatitis B and OPV. Serum rotavirus antibody responses were detected in 12 of 20 infants after 1 dose, and in 19/19 of the vaccinees after three doses. Neutralizing antibody responses were detected more often against the bovine rotavirus UK strain (95%) than to human rotavirus VP7 serotypes 1 (37%), 2 (32%), 3 (32%) or 4 (32%). The efficacy of this quadrivalent rotavirus vaccine needs to be evaluated further.
KW - Diarrheal vaccine
KW - Human-bovine reassortant rotavirus vaccine
KW - Live attenuated virus vaccine
KW - Pediatric vaccine
KW - Rotavirus antibody
KW - Rotavirus immune responses
KW - Rotavirus vaccine
KW - Rotavirus vaccine immunity
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U2 - 10.1016/S0264-410X(01)00242-0
DO - 10.1016/S0264-410X(01)00242-0
M3 - Article
C2 - 11535316
AN - SCOPUS:0035860598
SN - 0264-410X
VL - 19
SP - 4676
EP - 4684
JO - Vaccine
JF - Vaccine
IS - 32
ER -