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Development of a rotavirus vaccine: clinical safety, immunogenicity, and efficacy of the pentavalent rotavirus vaccine, RotaTeq.
Vaccine 2009; 27 Suppl 6:G72-81V

Abstract

Initial approaches for rotavirus vaccines were based on the classical "Jennerian" approach and utilized simian and bovine rotavirus strains, which provided cross-protection against human rotavirus strains but did not cause illness in infants and young children because of their species-specific tropism. The demonstrated efficacy of these vaccines was not consistent across studies. Thus, human-animal reassortants containing an animal rotavirus backbone with human rotavirus surface G and/or P proteins were developed, which demonstrated more consistent efficacy than that observed with the non-reassortant rotavirus strains. The pentavalent rotavirus vaccine, RotaTeq, contains 5 human-bovine reassortant rotaviruses consisting of a bovine (WC3) backbone with human rotavirus surface proteins representative of the most common G (G1, G2, G3, G4) or P (P1A[8]) types worldwide. The present review focuses on the development of the pentavalent rotavirus vaccine RotaTeq. Results of a large-scale Phase III clinical study showed that three doses of RotaTeq were immunogenic, efficacious, and well tolerated with no increased clinical risk of intussusception. RotaTeq was efficacious against rotavirus gastroenteritis of any severity (74%) and severe disease (98-100%), using a validated clinical scoring system. Reductions in rotavirus-associated hospitalizations and emergency department (ED) visits, for up to 2 years post-vaccination, were 95% in Europe, 97% in the United States, and 90% in the Latin American/Caribbean regions. RotaTeq was recently shown to be up to 100% effective in routine use in the US in reducing hospitalizations and ED visits and 96% effective in reducing physician visits. Additional studies in 8 different locations in the US have shown 85-95% reduction in rotavirus-associated hospitalizations and/or ED visits in the first 2-2.5 years of routine use.

Authors+Show Affiliations

Infectious Diseases and Vaccines - Clinical Research Department, Merck Research Laboratories, North Wales, PA, USA.No affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

20006144

Citation

Ciarlet, Max, and Florian Schödel. "Development of a Rotavirus Vaccine: Clinical Safety, Immunogenicity, and Efficacy of the Pentavalent Rotavirus Vaccine, RotaTeq." Vaccine, vol. 27 Suppl 6, 2009, pp. G72-81.
Ciarlet M, Schödel F. Development of a rotavirus vaccine: clinical safety, immunogenicity, and efficacy of the pentavalent rotavirus vaccine, RotaTeq. Vaccine. 2009;27 Suppl 6:G72-81.
Ciarlet, M., & Schödel, F. (2009). Development of a rotavirus vaccine: clinical safety, immunogenicity, and efficacy of the pentavalent rotavirus vaccine, RotaTeq. Vaccine, 27 Suppl 6, pp. G72-81. doi:10.1016/j.vaccine.2009.09.107.
Ciarlet M, Schödel F. Development of a Rotavirus Vaccine: Clinical Safety, Immunogenicity, and Efficacy of the Pentavalent Rotavirus Vaccine, RotaTeq. Vaccine. 2009 Dec 30;27 Suppl 6:G72-81. PubMed PMID: 20006144.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development of a rotavirus vaccine: clinical safety, immunogenicity, and efficacy of the pentavalent rotavirus vaccine, RotaTeq. AU - Ciarlet,Max, AU - Schödel,Florian, PY - 2009/09/01/received PY - 2009/09/24/accepted PY - 2009/12/17/entrez PY - 2009/12/17/pubmed PY - 2010/3/12/medline SP - G72 EP - 81 JF - Vaccine JO - Vaccine VL - 27 Suppl 6 N2 - Initial approaches for rotavirus vaccines were based on the classical "Jennerian" approach and utilized simian and bovine rotavirus strains, which provided cross-protection against human rotavirus strains but did not cause illness in infants and young children because of their species-specific tropism. The demonstrated efficacy of these vaccines was not consistent across studies. Thus, human-animal reassortants containing an animal rotavirus backbone with human rotavirus surface G and/or P proteins were developed, which demonstrated more consistent efficacy than that observed with the non-reassortant rotavirus strains. The pentavalent rotavirus vaccine, RotaTeq, contains 5 human-bovine reassortant rotaviruses consisting of a bovine (WC3) backbone with human rotavirus surface proteins representative of the most common G (G1, G2, G3, G4) or P (P1A[8]) types worldwide. The present review focuses on the development of the pentavalent rotavirus vaccine RotaTeq. Results of a large-scale Phase III clinical study showed that three doses of RotaTeq were immunogenic, efficacious, and well tolerated with no increased clinical risk of intussusception. RotaTeq was efficacious against rotavirus gastroenteritis of any severity (74%) and severe disease (98-100%), using a validated clinical scoring system. Reductions in rotavirus-associated hospitalizations and emergency department (ED) visits, for up to 2 years post-vaccination, were 95% in Europe, 97% in the United States, and 90% in the Latin American/Caribbean regions. RotaTeq was recently shown to be up to 100% effective in routine use in the US in reducing hospitalizations and ED visits and 96% effective in reducing physician visits. Additional studies in 8 different locations in the US have shown 85-95% reduction in rotavirus-associated hospitalizations and/or ED visits in the first 2-2.5 years of routine use. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/20006144/Development_of_a_rotavirus_vaccine:_clinical_safety_immunogenicity_and_efficacy_of_the_pentavalent_rotavirus_vaccine_RotaTeq_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(09)01465-0 DB - PRIME DP - Unbound Medicine ER -