Tags

Type your tag names separated by a space and hit enter

Effects of the potency and composition of the multivalent human-bovine (WC3) reassortant rotavirus vaccine on efficacy, safety and immunogenicity in healthy infants.
Vaccine. 2006 May 29; 24(22):4821-9.V

Abstract

BACKGROUND

Rotavirus gastroenteritis, which causes substantial infant mortality and morbidity worldwide, is a vaccine-preventable disease. The purpose of this study was to evaluate different compositions and potencies (vaccine virus titers) of a live multivalent human-bovine (WC3) reassortant rotavirus vaccine in order to select the potency and composition of the vaccine for further development.

METHODS

The efficacy, safety, and immunogenicity of a G1, G2, G3, G4, and P1A pentavalent composition at three different potencies, a G1, G2, G3, G4 quadrivalent composition, and a P1A monovalent composition of an oral human-bovine (WC3) reassortant rotavirus vaccine were compared in a blinded, placebo-controlled trial conducted between 1998 and 2001 enrolling 1,946 healthy Finnish infants 2-8 months of age.

RESULTS

All potencies of the pentavalent and quadrivalent vaccines were efficacious (58-74%) against wild-type rotavirus gastroenteritis of any severity and 100% protective against severe rotavirus disease caused by vaccine G-serotypes through the first rotavirus season post-vaccination. The monovalent P1A vaccine was 53% efficacious against moderate-and-severe rotavirus gastroenteritis. Protection against rotavirus gastroenteritis of any severity was demonstrated through two and three rotavirus seasons for all vaccine compositions. After the third dose, the percentage of infants with >or=3-fold rise in baseline serum neutralizing antibody titers against G1 ranged from 62% to 86% for recipients of the pentavalent vaccine, depending on the potency. The incidence of fever, irritability, vomiting, and diarrhea did not significantly differ between vaccine and placebo groups. A 7-month-old male developed intussusception 9 days after the first dose of the low-potency pentavalent vaccine.

CONCLUSIONS

Based on the results of this trial, a pentavalent composition (G1, G2, G3, G4, and P1A) of human-bovine (WC3) reassortant rotavirus vaccine with a potency similar to that of the middle-potency pentavalent vaccine (approximately 8 x 10(6) plaque-forming units/dose) was selected for further development.

Authors+Show Affiliations

University of Tampere Medical School, Tampere, Finland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

16621194

Citation

Vesikari, Timo, et al. "Effects of the Potency and Composition of the Multivalent Human-bovine (WC3) Reassortant Rotavirus Vaccine On Efficacy, Safety and Immunogenicity in Healthy Infants." Vaccine, vol. 24, no. 22, 2006, pp. 4821-9.
Vesikari T, Clark HF, Offit PA, et al. Effects of the potency and composition of the multivalent human-bovine (WC3) reassortant rotavirus vaccine on efficacy, safety and immunogenicity in healthy infants. Vaccine. 2006;24(22):4821-9.
Vesikari, T., Clark, H. F., Offit, P. A., Dallas, M. J., DiStefano, D. J., Goveia, M. G., Ward, R. L., Schödel, F., Karvonen, A., Drummond, J. E., DiNubile, M. J., & Heaton, P. M. (2006). Effects of the potency and composition of the multivalent human-bovine (WC3) reassortant rotavirus vaccine on efficacy, safety and immunogenicity in healthy infants. Vaccine, 24(22), 4821-9.
Vesikari T, et al. Effects of the Potency and Composition of the Multivalent Human-bovine (WC3) Reassortant Rotavirus Vaccine On Efficacy, Safety and Immunogenicity in Healthy Infants. Vaccine. 2006 May 29;24(22):4821-9. PubMed PMID: 16621194.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of the potency and composition of the multivalent human-bovine (WC3) reassortant rotavirus vaccine on efficacy, safety and immunogenicity in healthy infants. AU - Vesikari,Timo, AU - Clark,H Fred, AU - Offit,Paul A, AU - Dallas,Michael J, AU - DiStefano,Daniel J, AU - Goveia,Michelle G, AU - Ward,Richard L, AU - Schödel,Florian, AU - Karvonen,Aino, AU - Drummond,James E, AU - DiNubile,Mark J, AU - Heaton,Penny M, Y1 - 2006/03/31/ PY - 2005/09/16/received PY - 2006/02/17/revised PY - 2006/03/03/accepted PY - 2006/4/20/pubmed PY - 2006/8/10/medline PY - 2006/4/20/entrez SP - 4821 EP - 9 JF - Vaccine JO - Vaccine VL - 24 IS - 22 N2 - BACKGROUND: Rotavirus gastroenteritis, which causes substantial infant mortality and morbidity worldwide, is a vaccine-preventable disease. The purpose of this study was to evaluate different compositions and potencies (vaccine virus titers) of a live multivalent human-bovine (WC3) reassortant rotavirus vaccine in order to select the potency and composition of the vaccine for further development. METHODS: The efficacy, safety, and immunogenicity of a G1, G2, G3, G4, and P1A pentavalent composition at three different potencies, a G1, G2, G3, G4 quadrivalent composition, and a P1A monovalent composition of an oral human-bovine (WC3) reassortant rotavirus vaccine were compared in a blinded, placebo-controlled trial conducted between 1998 and 2001 enrolling 1,946 healthy Finnish infants 2-8 months of age. RESULTS: All potencies of the pentavalent and quadrivalent vaccines were efficacious (58-74%) against wild-type rotavirus gastroenteritis of any severity and 100% protective against severe rotavirus disease caused by vaccine G-serotypes through the first rotavirus season post-vaccination. The monovalent P1A vaccine was 53% efficacious against moderate-and-severe rotavirus gastroenteritis. Protection against rotavirus gastroenteritis of any severity was demonstrated through two and three rotavirus seasons for all vaccine compositions. After the third dose, the percentage of infants with >or=3-fold rise in baseline serum neutralizing antibody titers against G1 ranged from 62% to 86% for recipients of the pentavalent vaccine, depending on the potency. The incidence of fever, irritability, vomiting, and diarrhea did not significantly differ between vaccine and placebo groups. A 7-month-old male developed intussusception 9 days after the first dose of the low-potency pentavalent vaccine. CONCLUSIONS: Based on the results of this trial, a pentavalent composition (G1, G2, G3, G4, and P1A) of human-bovine (WC3) reassortant rotavirus vaccine with a potency similar to that of the middle-potency pentavalent vaccine (approximately 8 x 10(6) plaque-forming units/dose) was selected for further development. SN - 0264-410X UR - https://www.unboundmedicine.com/medline/citation/16621194/Effects_of_the_potency_and_composition_of_the_multivalent_human_bovine__WC3__reassortant_rotavirus_vaccine_on_efficacy_safety_and_immunogenicity_in_healthy_infants_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(06)00288-X DB - PRIME DP - Unbound Medicine ER -