Статья

Safety and Efficacy of an Attenuated Vaccine against Severe Rotavirus Gastroenteritis

Guillermo M. Ruiz‐PalaciosInstituto Nacional de Ciencas Medicas y Nutricion, México Distrito Federal, MexicoIrene Pérez‐SchaelAddress reprint requests to Dr. O'Ryan at the Institute of Biomedical Sciences, Faculty of Medicine, University of Chile, Independencia 1027, Santiago, Chile, or at [email protected]F. Raúl VelázquezAddress reprint requests to Dr. O'Ryan at the Institute of Biomedical Sciences, Faculty of Medicine, University of Chile, Independencia 1027, Santiago, Chile, or at [email protected]Héctor AbateInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atThomas BreuerInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atSue Ann Costa ClemensInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atBrigitte CheuvartInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atFélix EspinozaInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atPaul GillardInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atBruce L. InnisInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atYolanda CervantesInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atAlexandre C. LinharesInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atPío LópezAddress reprint requests to Dr. O'Ryan at the Institute of Biomedical Sciences, Faculty of Medicine, University of Chile, Independencia 1027, Santiago, Chile, or at [email protected]Mercedes Macías-ParraAddress reprint requests to Dr. O'Ryan at the Institute of Biomedical Sciences, Faculty of Medicine, University of Chile, Independencia 1027, Santiago, Chile, or at [email protected]Eduardo Ortega‐BarríaAddress reprint requests to Dr. O'Ryan at the Institute of Biomedical Sciences, Faculty of Medicine, University of Chile, Independencia 1027, Santiago, Chile, or at [email protected]Vesta RichardsonInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atDoris Maribel Rivera-MedinaAddress reprint requests to Dr. O'Ryan at the Institute of Biomedical Sciences, Faculty of Medicine, University of Chile, Independencia 1027, Santiago, Chile, or at [email protected]Luis RiveraInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atBelén SalinasInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atNoris Pavía-RuzAddress reprint requests to Dr. O'Ryan at the Institute of Biomedical Sciences, Faculty of Medicine, University of Chile, Independencia 1027, Santiago, Chile, or at [email protected]Jorge SalmerónAddress reprint requests to Dr. O'Ryan at the Institute of Biomedical Sciences, Faculty of Medicine, University of Chile, Independencia 1027, Santiago, Chile, or at [email protected]Ricardo RüttimannAddress reprint requests to Dr. O'Ryan at the Institute of Biomedical Sciences, Faculty of Medicine, University of Chile, Independencia 1027, Santiago, Chile, or at [email protected]Juan Carlos TinocoInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atPilar RubioInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atErnesto NuñezAddress reprint requests to Dr. O'Ryan at the Institute of Biomedical Sciences, Faculty of Medicine, University of Chile, Independencia 1027, Santiago, Chile, or at [email protected]M. Lourdes GuerreroInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atJuan Pablo YarzábalAddress reprint requests to Dr. O'Ryan at the Institute of Biomedical Sciences, Faculty of Medicine, University of Chile, Independencia 1027, Santiago, Chile, or at [email protected]Silvia DamasoInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atNadia TornieporthInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atXavier Sáez‐LlorensAddress reprint requests to Dr. O'Ryan at the Institute of Biomedical Sciences, Faculty of Medicine, University of Chile, Independencia 1027, Santiago, Chile, or at [email protected]Rodrigo VergaraInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atTimo VesikariInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atAlain BouckenoogheInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atRalf ClemensInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atBéatrice De VosInstitute of Biomedical Sciences, Fac-ulty of Medicine, University of Chile, In-dependencia 1027, Santiago, Chile, or atMiguel O’RyanAddress reprint requests to Dr. O'Ryan at the Institute of Biomedical Sciences, Faculty of Medicine, University of Chile, Independencia 1027, Santiago, Chile, or at [email protected]

2006en

ABI

Аннотация

BACKGROUND: The safety and efficacy of an attenuated G1P[8] human rotavirus (HRV) vaccine were tested in a randomized, double-blind, phase 3 trial. METHODS: We studied 63,225 healthy infants from 11 Latin American countries and Finland who received two oral doses of either the HRV vaccine (31,673 infants) or placebo (31,552 infants) at approximately two months and four months of age. Severe gastroenteritis episodes were identified by active surveillance. The severity of disease was graded with the use of the 20-point Vesikari scale. Vaccine efficacy was evaluated in a subgroup of 20,169 infants (10,159 vaccinees and 10,010 placebo recipients). RESULTS: The efficacy of the vaccine against severe rotavirus gastroenteritis and against rotavirus-associated hospitalization was 85 percent (P<0.001 for the comparison with placebo) and reached 100 percent against more severe rotavirus gastroenteritis. Hospitalization for diarrhea of any cause was reduced by 42 percent (95 percent confidence interval, 29 to 53 percent; P<0.001). During the 31-day window after each dose, six vaccine recipients and seven placebo recipients had definite intussusception (difference in risk, -0.32 per 10,000 infants; 95 percent confidence interval, -2.91 to 2.18; P=0.78). CONCLUSIONS: Two oral doses of the live attenuated G1P[8] HRV vaccine were highly efficacious in protecting infants against severe rotavirus gastroenteritis, significantly reduced the rate of severe gastroenteritis from any cause, and were not associated with an increased risk of intussusception. (ClinicalTrials.gov numbers, NCT00139347 and NCT00263666.)

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Идентификаторы

DOI: 10.1056/nejmoa052434

Цитирования и источники

Цитирований: 2Использованных источников: 0

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