RESUMEN
BACKGROUND/PURPOSE: Rotavirus infection is the most common etiology of acute gastroenteritis in young children worldwide. The first rotavirus vaccine was licensed by the United States Food and Drug Administration in 1998 but was suspended soon after in 1999 because of the possibility of induced intussusception. This study evaluated the safety and immunogenicity of a newly developed pentavalent rotavirus vaccine in Taiwanese children. METHODS: This was a phase III global trial designed to evaluate the safety and immunogenicity of an oral, live pentavalent rotavirus vaccine (RotaTeq). Taiwan was the only site in Asia enrolled in this trial. Normal healthy infants aged 6-12 weeks were enrolled, and each of the subjects received either three oral doses of the vaccine or placebo solution. The safety of the vaccine, particularly the risk of intussusception, and immunogenicity were studied. RESULTS: A total of 189 infants were enrolled. No increased risk of intussusception or other adverse reactions were noted following the vaccination. RotaTeq was immunogenic among subjects enrolled in Taiwan. At least a three-fold rise in serum antirotavirus IgA antibody was found among 93% of the vaccine group. The immunogenicity of RotaTeq in Taiwan was comparable to that in other areas. CONCLUSION: The pentavalent human-bovine vaccine, RotaTeq, was safe, generally well-tolerated, and immunogenic among Taiwanese infants.
Asunto(s)
Vacunas contra Rotavirus/uso terapéutico , Femenino , Gastroenteritis/prevención & control , Gastroenteritis/virología , Humanos , Lactante , Masculino , Vacunas contra Rotavirus/inmunología , Taiwán , Vacunas Atenuadas/inmunología , Vacunas Atenuadas/uso terapéuticoAsunto(s)
Anticuerpos Antivirales/sangre , Subtipo H1N1 del Virus de la Influenza A/inmunología , Gripe Humana/epidemiología , Adulto , Anciano , Anciano de 80 o más Años , Reacciones Cruzadas , Humanos , Gripe Humana/inmunología , Persona de Mediana Edad , Estudios Seroepidemiológicos , Taiwán/epidemiologíaRESUMEN
The susceptibility of five cell lines, RD, MRC-5, MK-2, Hep-2 and A549, for various serotypes of human enteroviruses was evaluated. RD cells were susceptible to most serotypes of enteroviruses, especially for human enterovirus A. Consequently, a high prevalence of human enterovirus A in Taiwan may reflect the relative importance of RD cells in the clinical virology laboratory. However, susceptibilities of RD cells to coxsackievirus A9 and A24, and echovirus 9 and 11 were exceptionally low. Alternatively, MRC-5 or MK-2 cells can improve the isolation of these four enteroviruses.