title: Safety, humoral and cell mediated immune responses to two formulations of an inactivated, split-virion influenza A/H5N1 vaccine in children.
abstract: BACKGROUND
  Highly pathogenic influenza A/H5N1 has caused outbreaks in wild birds and poultry in Asia, Africa and Europe. It has also infected people, especially children, causing severe illness and death. Although the virus shows limited ability to transmit between humans, A/H5N1 represents a potential source of the next influenza pandemic. This study assesses the safety and immunogenicity of aluminium hydroxide adjuvanted (Al) and non adjuvanted influenza A/Vietnam/1194/2004 NIBRG-14 (H5N1) vaccine in children.
  
  
  RESULTS
  In a Phase II, open, randomised, multicentre trial 180 children aged 6 months to 17 years received two injections, 21 days apart, of vaccine containing either: 30 microg haemagglutinin (HA) with adjuvant (30 microg+Al) or 7.5 microg HA without adjuvant. An additional 60 children aged 6-35 months received two "half dose" injections (ie 15 microg+Al or 3.8 microg). Safety was followed for 21 days after vaccination. Antibody responses were assessed 21 days after each injection and cellular immune responses were explored. Vaccination appeared well tolerated in all age groups. The 30 microg+Al formulation was more immunogenic than 7.5 microg in all age groups: in these two groups 79% and 46% had haemagglutinination inhibition antibody titres > or =32 (1/dil). Among 6-35 month-olds, the full doses were more immunogenic than their half dose equivalents. Vaccination induced a predominantly Th2 response against H5 HA.
  
  
  CONCLUSIONS
  This influenza A(H5N1) vaccine was well tolerated and immunogenic in children and infants, with Al adjuvant providing a clear immunogenic advantage. These results demonstrate that an H5N1 Al-adjuvanted vaccine, previously shown to be immunogenic and safe in adults, can also be used in children, the group most at risk for pandemic influenza.
authors.affiliation: Queen Sirikit National Institute of Child Health, Bangkok, Thailand.
authors.forename: Tawee
authors.initials: T
authors.lastname: Chotpitayasunondh
authors.forename: Usa
authors.initials: U
authors.lastname: Thisyakorn
authors.forename: Chitsanu
authors.initials: C
authors.lastname: Pancharoen
authors.forename: Stephanie
authors.initials: S
authors.lastname: Pepin
authors.forename: Nolwenn
authors.initials: N
authors.lastname: Nougarede
mesh_terms: D000276:Adjuvants, Immunologic / Q000737:chemistry; D000293:Adolescent; D000536:Aluminum Hydroxide / Q000737:chemistry; D002648:Child; D002675:Child, Preschool; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007223:Infant; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D008297:Male; D009500:Neutralization Tests; D016896:Treatment Outcome; D014611:Vaccination
chemical_list: D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines; D000536:Aluminum Hydroxide