RESUMO
Clinical Trials Registration: NCT01190228.
Assuntos
Anticorpos Antivirais/sangue , Formação de Anticorpos , Vírus da Encefalite Japonesa (Espécie)/imunologia , Encefalite Japonesa/prevenção & controle , Imunização Secundária , Vacinas contra Encefalite Japonesa/administração & dosagem , Vacinas contra Encefalite Japonesa/imunologia , Anticorpos Neutralizantes/sangue , Pré-Escolar , Seguimentos , Humanos , Masculino , FilipinasRESUMO
BACKGROUND: Dengue is a major public health concern in pediatric populations in endemic regions. A recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV) is under development for the control of dengue with a 3-dose (0-6-12 month) vaccination schedule. METHODS: In this controlled phase II trial conducted in the Philippines, 210 toddlers aged 12-15 months were randomized to 4 groups: 3 groups received the CYD-TDV vaccination schedule and a measles, mumps and rubella (MMR) vaccine given either concomitantly with the first CYD-TDV dose or 1 month earlier; 1 group received 3 active control vaccines. Safety and reactogenicity were assessed after each dose. Immunogenicity was assessed 30 days after vaccinations using the plaque reduction neutralization test against dengue and enzyme-linked immunosorbent assay methods against MMR antigens. RESULTS: Injection site and systemic reactions occurred at similar rates across CYD-TDV groups, except for fever, which was more frequent after CYD-TDV and MMR coadministration (28.8%) compared with other groups (12-20%). Reactogenicity did not increase with subsequent CYD-TDV injections. There were no safety issues with the study vaccine. CYD-TDV achieved a balanced antibody response to all 4 dengue serotypes across the study groups, with geometric mean titers in the range of 105-124, 147-213, 311-387 and 127-160 for serotypes 1, 2, 3 and 4, respectively. CYD-TDV coadministration did not affect MMR immunogenicity (≥95% seroprotection against MMR) and vice versa. CONCLUSIONS: The CYD-TDV has an acceptable safety and immunogenicity profile in toddlers and when coadministered with MMR.
Assuntos
Vacinas contra Dengue , Vacina contra Sarampo-Caxumba-Rubéola , Anticorpos Antibacterianos/sangue , Anticorpos Antivirais/sangue , Dengue , Vacinas contra Dengue/administração & dosagem , Vacinas contra Dengue/efeitos adversos , Vacinas contra Dengue/imunologia , Feminino , Humanos , Esquemas de Imunização , Lactente , Masculino , Vacina contra Sarampo-Caxumba-Rubéola/administração & dosagem , Vacina contra Sarampo-Caxumba-Rubéola/efeitos adversos , Vacina contra Sarampo-Caxumba-Rubéola/imunologia , ViremiaRESUMO
BACKGROUND: Recommended treatment for severe rabies exposure in unvaccinated individuals includes wound cleaning, administration of rabies immunoglobulins (RIG), and rabies vaccination. We conducted a survey of rabies treatment outcomes in the Philippines. METHODS: This was a case series involving 7,660 patients (4 months to 98 years of age) given purified equine RIG (pERIG) at the Research Institute for Tropical Medicine (Muntinlupa, Philippines) from July 2003 to August 2004 following Category II or III exposures. Data on local and systemic adverse reactions (AR) within 28 days and biting animal status were recorded; outcome data were obtained by telephone or home visit 6-29 months post-exposure. RESULTS: Follow-up data were collected for 6,464 patients. Of 151 patients with laboratory-confirmed rabies exposure, 143 were in good health 6-48 months later, seven could not be contacted, and one 4-year-old girl died. Of 16 deaths in total, 14 were unrelated to rabies exposure or treatment. Two deaths were considered PEP failures: the 4-year old girl, who had multiple deep lacerated wounds from a rabid dog of the nape, neck, and shoulders requiring suturing on the day of exposure, and an 8-year-old boy who only received rabies PEP on the day of exposure. CONCLUSIONS: This extensive review of outcomes in persons with Category III exposure shows the recommended treatment schedule at RITM using pERIG is well tolerated, while survival of 143 laboratory-confirmed rabies exposures confirms the intervention efficacy. Two PEP intervention failures demonstrate that sustained education and training is essential in rabies management.