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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.
Pediatr Infect Dis J. 2012 Apr; 31(4):e59-65.PI

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 µg) 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 µg 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 µg 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.

Authors+Show Affiliations

Nassim and Associates, Pediatric Medicine, New Albany, IN, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22418661

Citation

Nassim, Cynthia, et al. "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." The Pediatric Infectious Disease Journal, vol. 31, no. 4, 2012, pp. e59-65.
Nassim C, Christensen S, Henry D, et al. 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. Pediatr Infect Dis J. 2012;31(4):e59-65.
Nassim, C., Christensen, S., Henry, D., Holmes, S., Hohenboken, M., & Kanesa-Thasan, N. (2012). 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. The Pediatric Infectious Disease Journal, 31(4), e59-65. https://doi.org/10.1097/INF.0b013e31824b9545
Nassim C, et al. 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. Pediatr Infect Dis J. 2012;31(4):e59-65. PubMed PMID: 22418661.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Nassim,Cynthia, AU - Christensen,Shane, AU - Henry,Dan, AU - Holmes,Sandra, AU - Hohenboken,Matthew, AU - Kanesa-Thasan,Niranjan, PY - 2012/3/16/entrez PY - 2012/3/16/pubmed PY - 2012/7/17/medline SP - e59 EP - 65 JF - The Pediatric infectious disease journal JO - Pediatr Infect Dis J VL - 31 IS - 4 N2 - 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 µg) 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 µg 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 µg 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. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/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_ L2 - https://doi.org/10.1097/INF.0b013e31824b9545 DB - PRIME DP - Unbound Medicine ER -