tetano
Editor, Senior Moderator
Pediatr Infect Dis J. 2012 Apr;31(4):e59-65.
Identification of Antigen and Adjuvant Doses Resulting in Optimal Immunogenicity and Antibody Persistence up to 1 Year After Immunization With a Pandemic A/H1N1 Influenza Vaccine in Children 3 to ,9 Years of Age.
Nassim C, Christensen S, Henry D, Holmes S, Hohenboken M, Kanesa-Thasan N.
Source
*Nassim and Associates, Pediatric Medicine, New Albany, IN ?J. Lewis Research, Inc. Foothill Family Clinic South and Foothill Family Clinic, Salt Lake City, UT ?Novartis Vaccine and Diagnostics, Cambridge, MA.
Abstract
BACKGROUND:
: In the development of pediatric A/H1N1 influenza vaccines, this study was performed to identify antigen and adjuvant doses providing optimal immunogenicity and antibody persistence to ensure long-term immunity after immunization with an adjuvanted A/H1N1 vaccine in children 3 to <9 years of age.
METHODS:
: Healthy children (N = 1357) were immunized with 1 of 8 investigational vaccine formulations ranging in antigen (3.75-30 ?g) and MF59 adjuvant (Novartis Vaccines, Marburg, Germany; 0, 50 and 100% of standard dose). Each participant received 2 vaccine doses given 3 weeks apart. Immunogenicity was analyzed by hemagglutination inhibition assay in sera drawn 3, 4 and 6 weeks after first vaccination. Long-term antibody persistence was assessed 6 and 12 months after immunization. Vaccine safety was monitored throughout the study.
RESULTS:
: All MF59-adjuvanted vaccines were well tolerated and highly immunogenic, with adjuvanted formulations inducing antibody titers statistically superior to those of the nonadjuvanted vaccines. Each MF59-adjuvanted vaccine met all the US and European licensure criteria for influenza vaccines 3 weeks after the administration of a single dose; all nonadjuvanted formulations failed to meet licensure criteria at this time point. Antibody titers in response to a single vaccination with 7.5 ?g antigen and a full dose of MF59 continued to meet all US and European licensure criteria up to 1 year after immunization.
CONCLUSION:
: A single dose of vaccine containing 7.5 ?g A/California/7/2009 (H1N1) antigen and a full dose of MF59 adjuvant was found to be optimal for children 3 to <9 years of age.
PMID:
22418661
[PubMed - in process]
http://www.ncbi.nlm.nih.gov/pubmed/22418661
Identification of Antigen and Adjuvant Doses Resulting in Optimal Immunogenicity and Antibody Persistence up to 1 Year After Immunization With a Pandemic A/H1N1 Influenza Vaccine in Children 3 to ,9 Years of Age.
Nassim C, Christensen S, Henry D, Holmes S, Hohenboken M, Kanesa-Thasan N.
Source
*Nassim and Associates, Pediatric Medicine, New Albany, IN ?J. Lewis Research, Inc. Foothill Family Clinic South and Foothill Family Clinic, Salt Lake City, UT ?Novartis Vaccine and Diagnostics, Cambridge, MA.
Abstract
BACKGROUND:
: In the development of pediatric A/H1N1 influenza vaccines, this study was performed to identify antigen and adjuvant doses providing optimal immunogenicity and antibody persistence to ensure long-term immunity after immunization with an adjuvanted A/H1N1 vaccine in children 3 to <9 years of age.
METHODS:
: Healthy children (N = 1357) were immunized with 1 of 8 investigational vaccine formulations ranging in antigen (3.75-30 ?g) and MF59 adjuvant (Novartis Vaccines, Marburg, Germany; 0, 50 and 100% of standard dose). Each participant received 2 vaccine doses given 3 weeks apart. Immunogenicity was analyzed by hemagglutination inhibition assay in sera drawn 3, 4 and 6 weeks after first vaccination. Long-term antibody persistence was assessed 6 and 12 months after immunization. Vaccine safety was monitored throughout the study.
RESULTS:
: All MF59-adjuvanted vaccines were well tolerated and highly immunogenic, with adjuvanted formulations inducing antibody titers statistically superior to those of the nonadjuvanted vaccines. Each MF59-adjuvanted vaccine met all the US and European licensure criteria for influenza vaccines 3 weeks after the administration of a single dose; all nonadjuvanted formulations failed to meet licensure criteria at this time point. Antibody titers in response to a single vaccination with 7.5 ?g antigen and a full dose of MF59 continued to meet all US and European licensure criteria up to 1 year after immunization.
CONCLUSION:
: A single dose of vaccine containing 7.5 ?g A/California/7/2009 (H1N1) antigen and a full dose of MF59 adjuvant was found to be optimal for children 3 to <9 years of age.
PMID:
22418661
[PubMed - in process]
http://www.ncbi.nlm.nih.gov/pubmed/22418661