tetano
Editor, Senior Moderator
Pediatr Infect Dis J. 2010 Mar 31. [Epub ahead of print]
Immunogenicity and Safety of H5N1 A/Vietnam/1194/2004 (Clade 1) AS03-Adjuvanted Prepandemic Candidate Influenza Vaccines in Children Aged 3 to 9 Years: A Phase II, Randomized, Open, Controlled Study.
D?ez-Domingo J, Garc?s-Sanchez M, Bald? JM, Planelles MV, Ubeda I, Jubert A, Mar?s J, Moris P, Garcia-Corbeira P, Dram? M, Gillard P.
From the *Centro Superior de Investigaci?n en Salud P?blica (CSISP), Valencia, Spain; daggerCentro de Salud Guillem de Castro, Valencia, Spain; double daggerCentro de Salud Quart de Poblet, Valencia, Spain; section signCentro de Salud Paiporta, Valencia, Spain; paragraph signCentro de Salud La Eliana, Valencia, Spain; parallelCentro de Salud Malvarrosa, Valencia, Spain; **Institut Pediatric Mar?s Riera, Gerona, Spain; daggerdaggerGlaxoSmithKline Biologicals, Rixensart, Belgium; and double daggerdouble daggerGlaxoSmithKline, Madrid, Spain.
Abstract
BACKGROUND:: The development of vaccines against pandemic influenza viruses for use in children is a public health priority. METHODS:: In this phase II, randomized, open study, the immunogenicity and reactogenicity of H5N1 A/Vietnam/1194/2004 (NIBRG-14) (clade 1) prepandemic influenza vaccine were assessed in children aged 3 to 5 and 6 to 9 years. Children were randomized to receive 2 doses, given 21 days apart, of A/Vietnam/1194/2004 vaccine containing 1.9 mug or 3.75 mug hemagglutinin antigen (HA), adjuvanted with a tocopherol-based oil-in-water emulsion (AS03) containing 11.86 mg (AS03A) or 5.93 mg (AS03B) tocopherol. Control groups received 2 doses of trivalent influenza vaccine (TIV). Humoral immune responses, reactogenicity, and safety were the primary outcome measures; cross-reactivity and cell-mediated responses were also assessed (NCT00502593). RESULTS:: Between 49 and 51 children in each age stratum (aged 3-5 and 6-9 years) received H5N1 vaccine, and between 17 and 18 children in each age stratum received TIV. After the second dose, recipients of H5N1 vaccine (1.9 mug HA/AS03B, 3.75 mug HA/AS03B, and 3.75 mug HA/AS03A) achieved humoral antibody titers against the vaccine-homologous strain, which fulfilled the United States influenza vaccines licensure criteria for immunogenicity. With the exception of 1 child, there were no H5N1 immune responses in children who received TIV. The most frequent injection-site event was pain in all groups, and the H5N1 vaccine had a clinically acceptable reactogenicity and safety profile. Exploratory analyses in children aged 3 to 5 years indicated that the induction of CD4 T-cell responses polarized in favor of a T-helper 1 profile. CONCLUSIONS:: The results showed that 2 doses of AS03-adjuvanted H5N1 influenza vaccine at antigen-sparing doses of 1.9 mug or 3.75 mug HA elicited broad and persistent immune responses with acceptable reactogenicity, and without safety concerns, in children aged 3 to 9 years.
PMID: 20375709 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/20375709
Immunogenicity and Safety of H5N1 A/Vietnam/1194/2004 (Clade 1) AS03-Adjuvanted Prepandemic Candidate Influenza Vaccines in Children Aged 3 to 9 Years: A Phase II, Randomized, Open, Controlled Study.
D?ez-Domingo J, Garc?s-Sanchez M, Bald? JM, Planelles MV, Ubeda I, Jubert A, Mar?s J, Moris P, Garcia-Corbeira P, Dram? M, Gillard P.
From the *Centro Superior de Investigaci?n en Salud P?blica (CSISP), Valencia, Spain; daggerCentro de Salud Guillem de Castro, Valencia, Spain; double daggerCentro de Salud Quart de Poblet, Valencia, Spain; section signCentro de Salud Paiporta, Valencia, Spain; paragraph signCentro de Salud La Eliana, Valencia, Spain; parallelCentro de Salud Malvarrosa, Valencia, Spain; **Institut Pediatric Mar?s Riera, Gerona, Spain; daggerdaggerGlaxoSmithKline Biologicals, Rixensart, Belgium; and double daggerdouble daggerGlaxoSmithKline, Madrid, Spain.
Abstract
BACKGROUND:: The development of vaccines against pandemic influenza viruses for use in children is a public health priority. METHODS:: In this phase II, randomized, open study, the immunogenicity and reactogenicity of H5N1 A/Vietnam/1194/2004 (NIBRG-14) (clade 1) prepandemic influenza vaccine were assessed in children aged 3 to 5 and 6 to 9 years. Children were randomized to receive 2 doses, given 21 days apart, of A/Vietnam/1194/2004 vaccine containing 1.9 mug or 3.75 mug hemagglutinin antigen (HA), adjuvanted with a tocopherol-based oil-in-water emulsion (AS03) containing 11.86 mg (AS03A) or 5.93 mg (AS03B) tocopherol. Control groups received 2 doses of trivalent influenza vaccine (TIV). Humoral immune responses, reactogenicity, and safety were the primary outcome measures; cross-reactivity and cell-mediated responses were also assessed (NCT00502593). RESULTS:: Between 49 and 51 children in each age stratum (aged 3-5 and 6-9 years) received H5N1 vaccine, and between 17 and 18 children in each age stratum received TIV. After the second dose, recipients of H5N1 vaccine (1.9 mug HA/AS03B, 3.75 mug HA/AS03B, and 3.75 mug HA/AS03A) achieved humoral antibody titers against the vaccine-homologous strain, which fulfilled the United States influenza vaccines licensure criteria for immunogenicity. With the exception of 1 child, there were no H5N1 immune responses in children who received TIV. The most frequent injection-site event was pain in all groups, and the H5N1 vaccine had a clinically acceptable reactogenicity and safety profile. Exploratory analyses in children aged 3 to 5 years indicated that the induction of CD4 T-cell responses polarized in favor of a T-helper 1 profile. CONCLUSIONS:: The results showed that 2 doses of AS03-adjuvanted H5N1 influenza vaccine at antigen-sparing doses of 1.9 mug or 3.75 mug HA elicited broad and persistent immune responses with acceptable reactogenicity, and without safety concerns, in children aged 3 to 9 years.
PMID: 20375709 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/20375709