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Immunogenicity and tolerability of an MF59-adjuvanted, egg-derived, A/H1N1 pandemic influenza vaccine in children 6-35 months of age.
Pediatr Infect Dis J. 2014 Dec; 33(12):e320-9.PI

Abstract

BACKGROUND

Vaccines against pandemic A/H1N1 influenza should provide protective immunity in children, because they are at greater risk of disease than adults. This study was conducted to identify the optimal dose of an MF59®-adjuvanted, egg-derived, A/H1N1 influenza vaccine for young children.

METHODS

Children 6-11 months (N = 144) and 12-35 months (N = 186) of age received vaccine formulations containing either 3.75 μg antigen with half the standard dose of MF59 or 7.5 μg antigen with a standard dose of MF59, or a nonadjuvanted formulation containing 15 μg antigen (children 12-35 months only). Participants were given 2 primary vaccine doses 3 weeks apart, followed by 1 booster dose of MF59-adjuvanted seasonal influenza vaccine 1 year later. Immunogenicity was assessed by hemagglutination inhibition and microneutralization assays.

RESULTS

All vaccine formulations were highly immunogenic and met all 3 European licensure criteria after 2 doses. MF59-adjuvanted vaccines met all licensure criteria after 1 dose in both age cohorts, while nonadjuvanted vaccine did not meet all criteria after 1 dose in children 12-35 months. A single booster dose was highly immunogenic, and stable antibody persistence was observed in response to all vaccines. All vaccines were well tolerated.

CONCLUSIONS

In this study, a single dose of 3.75 μg antigen with half the standard dose of MF59 was shown to be optimal, providing adequate levels of immediate and long-term antibodies in pediatric subjects 6-35 months of age. These data demonstrated that MF59 adjuvant allowed for reduced antigen content and promoted significant long-term antibody persistence in children, with a satisfactory safety profile.

Authors+Show Affiliations

From the *Zentrum für Kinder-und Jugendmedizin, Universitätsmedizin, Rheinland-Pfalz, Germany; †Center for Vaccinology, Ghent University and University Hospital, Ghent, Belgium; ‡Vaxinostics BV, University Vaccine Center Rotterdam Nijmegen, Rotterdam, The Netherlands; §Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago de Chile, Chile; ¶Hospital Maternidad Ntra Sra. de la Altagracia, Gazcue, Santo Domingo, The Dominican Republic; and ‖Novartis Vaccines and Diagnostics, Inc., Cambridge, Massachusetts.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

24978857

Citation

Knuf, Markus, et al. "Immunogenicity and Tolerability of an MF59-adjuvanted, Egg-derived, A/H1N1 Pandemic Influenza Vaccine in Children 6-35 Months of Age." The Pediatric Infectious Disease Journal, vol. 33, no. 12, 2014, pp. e320-9.
Knuf M, Leroux-Roels G, Rümke HC, et al. Immunogenicity and tolerability of an MF59-adjuvanted, egg-derived, A/H1N1 pandemic influenza vaccine in children 6-35 months of age. Pediatr Infect Dis J. 2014;33(12):e320-9.
Knuf, M., Leroux-Roels, G., Rümke, H. C., Abarca, K., Rivera, L., Lattanzi, M., Pedotti, P., Arora, A., Kieninger-Baum, D., & Della Cioppa, G. (2014). Immunogenicity and tolerability of an MF59-adjuvanted, egg-derived, A/H1N1 pandemic influenza vaccine in children 6-35 months of age. The Pediatric Infectious Disease Journal, 33(12), e320-9. https://doi.org/10.1097/INF.0000000000000462
Knuf M, et al. Immunogenicity and Tolerability of an MF59-adjuvanted, Egg-derived, A/H1N1 Pandemic Influenza Vaccine in Children 6-35 Months of Age. Pediatr Infect Dis J. 2014;33(12):e320-9. PubMed PMID: 24978857.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and tolerability of an MF59-adjuvanted, egg-derived, A/H1N1 pandemic influenza vaccine in children 6-35 months of age. AU - Knuf,Markus, AU - Leroux-Roels,Geert, AU - Rümke,Hans C, AU - Abarca,Katia, AU - Rivera,Luis, AU - Lattanzi,Maria, AU - Pedotti,Paola, AU - Arora,Ashwani, AU - Kieninger-Baum,Dorothee, AU - Della Cioppa,Giovanni, PY - 2014/7/1/entrez PY - 2014/7/1/pubmed PY - 2015/6/27/medline SP - e320 EP - 9 JF - The Pediatric infectious disease journal JO - Pediatr Infect Dis J VL - 33 IS - 12 N2 - BACKGROUND: Vaccines against pandemic A/H1N1 influenza should provide protective immunity in children, because they are at greater risk of disease than adults. This study was conducted to identify the optimal dose of an MF59®-adjuvanted, egg-derived, A/H1N1 influenza vaccine for young children. METHODS: Children 6-11 months (N = 144) and 12-35 months (N = 186) of age received vaccine formulations containing either 3.75 μg antigen with half the standard dose of MF59 or 7.5 μg antigen with a standard dose of MF59, or a nonadjuvanted formulation containing 15 μg antigen (children 12-35 months only). Participants were given 2 primary vaccine doses 3 weeks apart, followed by 1 booster dose of MF59-adjuvanted seasonal influenza vaccine 1 year later. Immunogenicity was assessed by hemagglutination inhibition and microneutralization assays. RESULTS: All vaccine formulations were highly immunogenic and met all 3 European licensure criteria after 2 doses. MF59-adjuvanted vaccines met all licensure criteria after 1 dose in both age cohorts, while nonadjuvanted vaccine did not meet all criteria after 1 dose in children 12-35 months. A single booster dose was highly immunogenic, and stable antibody persistence was observed in response to all vaccines. All vaccines were well tolerated. CONCLUSIONS: In this study, a single dose of 3.75 μg antigen with half the standard dose of MF59 was shown to be optimal, providing adequate levels of immediate and long-term antibodies in pediatric subjects 6-35 months of age. These data demonstrated that MF59 adjuvant allowed for reduced antigen content and promoted significant long-term antibody persistence in children, with a satisfactory safety profile. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/24978857/Immunogenicity_and_tolerability_of_an_MF59_adjuvanted_egg_derived_A/H1N1_pandemic_influenza_vaccine_in_children_6_35_months_of_age_ L2 - https://doi.org/10.1097/INF.0000000000000462 DB - PRIME DP - Unbound Medicine ER -