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A fully liquid DTPw-HepB-Hib combination vaccine for booster vaccination of toddlers in El Salvador

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Date
2010
Author
Suárez, Eduardo
Asturias, Edwin J
Hilbert, Anne Katrin
Herzog, Christian
Aeberhard, Ursula
Spyr, Christian
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Abstract
Objectives:To compare the safety and immunogenicity of a booster dose of a fully liquid diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b (DTPw-HepB-Hib) vaccine to the separate administration of commercially available DTPw and Hib vaccines in healthy toddlers. Methods:An open-label, randomized, parallel-group, Phase III study conducted at six centers in San Salvador, El Salvador, during February-June 2006. Toddlers (15-24 months of age) were eligible to participate if they had received primary immunization at 2, 4, and 6 months of age with a commercial DTPw-HepB/Hib vaccine requiring reconstitution. Participants received either one booster dose of DTPw-HepB-Hib fully liquid vaccine or DTPw and Hib vaccines administered separately. Blood samples were taken immediately prior to and at 1 month post-vaccination. For a 5-day period following vaccination, solicited adverse events were collected in subject diaries and assessed. Results:The combined DTPw-HepB-Hib fully liquid vaccine was non-inferior to the separately administered DTPw and Hib vaccines, in terms of seroprotection/seroconversion rates for all antigens evaluated. The combination vaccine elicited a strong booster response as demonstrated by a large increase in antibodies against all vaccine antigens. The geometric mean concentrations (GMCs) of all antibodies in the DTPw-HepB-Hib group exceeded the seroprotection/seroconversion thresholds by very large margins, although for some antigens they were somewhat lower than the corresponding titers in the comparator group. With the combination vaccine, considerably fewer solicited local and systemic adverse events, such as fever and irritability, were reported than with the comparator vaccines. Conclusions:This study demonstrates that the fully liquid combined DTPw-HepB-Hib vaccine is highly immunogenic and has a favorable safety profile when given as a booster vaccination to toddlers who have received...(AU)
 
Objetivos:Comparar la seguridad y la inmunogenicidad en infantes saludables de una dosis de refuerzo de una vacuna líquida combinada contra la difteria, el tétanos, la tosferina (de células enteras), la hepatitis B y Haemophilus influenzae tipo b (DTPw-HepB-Hib), con la aplicación por separado de vacunas DTPw y Hib disponibles comercialmente. Métodos:Se realizó un estudio de fase III abierto, aleatorizado, con grupos paralelos, en seis centros de San Salvador, El Salvador, en febrero-junio de 2006. Los infantes (de 15-24 meses) habían recibido la inmunización primaria a los 2, 4 y 6 meses de edad con una vacuna comercial DTPw-HepB/Hib que necesitaba reconstitución. Los lactantes recibieron una dosis de refuerzo con la vacuna DTPw-HepB-Hib o las vacunas DTPw y Hib por separado. Se tomaron muestras de sangre inmediatamente antes de la vacunación y un mes después. Las reacciones adversas en los cinco días siguientes a la vacunación se anotaron en diarios individuales y se evaluaron. Resultados:Según las tasas de seroprotección/seroconversión de todos los antígenos evaluados, la vacuna DTPw-HepB-Hib no fue inferior que las vacunas DTPw y Hib administradas por separado. La vacuna combinada produjo una fuerte respuesta de refuerzo, reflejada en el gran aumento de anticuerpos contra todos los antígenos presentes. Con respecto al grupo de comparación, en el grupo vacunado con DTPw-HepB-Hib las concentraciones geométricas medias de todos los anticuerpos superaron ampliamente los umbrales de seroprotección/seroconversión -aunque con títulos menores en algunos antígenos- y hubo mucho menos reacciones adversas locales y sistémicas, como fiebre e irritabilidad. Conclusiones:Se demostró que la vacuna líquida combinada DTPw-HepB-Hib es altamente inmunógena y satisfactoriamente segura cuando se aplica como dosis de refuerzo a infantes inmunizados primariamente con una vacuna pentavalente diferente que requiere reconstitución.(AU)
 
Series
Rev Panam Salud Publica;27(2),feb. 2010
Subject
Vaccines; Immunization, Methods; Hepatitis B Vaccines; Haemophilus Vaccines; Diphtheria-Tetanus-Pertussis Vaccine; Infant; El Salvador; Vacunas; Esquema de Inmunización; Vacunas contra la Hepatitis B; Vacunas contra Haemophilus; Vacuna contra Difteria, Tétanos y Tos Ferina; Lactante; El Salvador; Vacina contra Difteria, Tétano e Coqueluche; Vacina contra Difteria, Tétano e Coqueluche; Vacinas Anti-Haemophilus; Vacinas Anti-Haemophilus; Vacinas contra Hepatite B; Vacinas contra Hepatite B; Imunização Secundária; El Salvador; Vacinas Combinadas
URI
http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892010000200005
https://iris.paho.org/handle/10665.2/9721
Citation
Suárez, Eduardo,Asturias, Edwin J,Hilbert, Anne Katrin,Herzog, Christian,Aeberhard, Ursula,Spyr, Christian (2010) A fully liquid DTPw-HepB-Hib combination vaccine for booster vaccination of toddlers in El Salvador. Rev Panam Salud Publica;27(2) 117-124,feb. 2010. Retrieved from http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892010000200005
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