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A dose-ranging study of MF59(®)-adjuvanted and non-adjuvanted A/H1N1 pandemic influenza vaccine in young to middle-aged and older adult populations to assess safety, immunogenicity, and antibody persistence one year after vaccination.
Hum Vaccin Immunother. 2014; 10(8):2395-407.HV

Abstract

BACKGROUND

During development of an A/H1N1 pandemic influenza vaccine, this study was performed to identify the antigen and adjuvant content which would provide optimal antibody response and persistence in adults and the elderly. Dose-sparing strategies, such as inclusion of adjuvants, are critical in ensuring the widest possible population coverage in the event of an influenza pandemic, despite a limited global capacity for vaccine manufacture.

METHODS

Healthy subjects aged 18-64 years (n = 1240) and ≥65 years (n = 1352) were vaccinated with 1 of 8 investigational vaccine formulations varying in antigen quantity (3.75 µg to 30 µg of hemagglutinin) and MF59(®) adjuvant (none, half dose, or full dose). All subjects received 2 vaccine doses administered 3 weeks apart. Antibody response was assessed by hemagglutination inhibition assay 1 and 3 weeks after administration of first and second doses. Antibody persistence was assessed after 6 and 12 mo. Vaccine safety was monitored over 12 mo.

RESULTS

All 8 investigational A/H1N1 vaccine formulations were well tolerated, and rapidly induced high antibody titers which met all of the Center for Biologics Evaluation and Research (CBER) and Committee for Medicinal Products for Human Use (CHMP) licensure criteria 3 weeks after one dose. The highest antibody titers were observed in participants vaccinated with higher quantities of antigen and adjuvant.

CONCLUSION

A single vaccine dose containing 3.75 µg of A/California/7/2009 (H1N1) antigen with MF59 adjuvant was identified as optimal for young to middle-aged (18-64 years) and older (≥65 years) adult populations.

Authors+Show Affiliations

a Primary Physicians Research, Medicine; Pittsburgh, PA USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

25424947

Citation

Reisinger, Keith S., et al. "A Dose-ranging Study of MF59(®)-adjuvanted and Non-adjuvanted A/H1N1 Pandemic Influenza Vaccine in Young to Middle-aged and Older Adult Populations to Assess Safety, Immunogenicity, and Antibody Persistence One Year After Vaccination." Human Vaccines & Immunotherapeutics, vol. 10, no. 8, 2014, pp. 2395-407.
Reisinger KS, Holmes SJ, Pedotti P, et al. A dose-ranging study of MF59(®)-adjuvanted and non-adjuvanted A/H1N1 pandemic influenza vaccine in young to middle-aged and older adult populations to assess safety, immunogenicity, and antibody persistence one year after vaccination. Hum Vaccin Immunother. 2014;10(8):2395-407.
Reisinger, K. S., Holmes, S. J., Pedotti, P., Arora, A. K., & Lattanzi, M. (2014). A dose-ranging study of MF59(®)-adjuvanted and non-adjuvanted A/H1N1 pandemic influenza vaccine in young to middle-aged and older adult populations to assess safety, immunogenicity, and antibody persistence one year after vaccination. Human Vaccines & Immunotherapeutics, 10(8), 2395-407. https://doi.org/10.4161/hv.29393
Reisinger KS, et al. A Dose-ranging Study of MF59(®)-adjuvanted and Non-adjuvanted A/H1N1 Pandemic Influenza Vaccine in Young to Middle-aged and Older Adult Populations to Assess Safety, Immunogenicity, and Antibody Persistence One Year After Vaccination. Hum Vaccin Immunother. 2014;10(8):2395-407. PubMed PMID: 25424947.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A dose-ranging study of MF59(®)-adjuvanted and non-adjuvanted A/H1N1 pandemic influenza vaccine in young to middle-aged and older adult populations to assess safety, immunogenicity, and antibody persistence one year after vaccination. AU - Reisinger,Keith S, AU - Holmes,Sandra J, AU - Pedotti,Paola, AU - Arora,Ashwani Kumar, AU - Lattanzi,Maria, PY - 2014/11/27/entrez PY - 2014/11/27/pubmed PY - 2015/7/15/medline KW - H1N1 KW - MF59 KW - adjuvant KW - influenza KW - pandemic KW - vaccine SP - 2395 EP - 407 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 10 IS - 8 N2 - BACKGROUND: During development of an A/H1N1 pandemic influenza vaccine, this study was performed to identify the antigen and adjuvant content which would provide optimal antibody response and persistence in adults and the elderly. Dose-sparing strategies, such as inclusion of adjuvants, are critical in ensuring the widest possible population coverage in the event of an influenza pandemic, despite a limited global capacity for vaccine manufacture. METHODS: Healthy subjects aged 18-64 years (n = 1240) and ≥65 years (n = 1352) were vaccinated with 1 of 8 investigational vaccine formulations varying in antigen quantity (3.75 µg to 30 µg of hemagglutinin) and MF59(®) adjuvant (none, half dose, or full dose). All subjects received 2 vaccine doses administered 3 weeks apart. Antibody response was assessed by hemagglutination inhibition assay 1 and 3 weeks after administration of first and second doses. Antibody persistence was assessed after 6 and 12 mo. Vaccine safety was monitored over 12 mo. RESULTS: All 8 investigational A/H1N1 vaccine formulations were well tolerated, and rapidly induced high antibody titers which met all of the Center for Biologics Evaluation and Research (CBER) and Committee for Medicinal Products for Human Use (CHMP) licensure criteria 3 weeks after one dose. The highest antibody titers were observed in participants vaccinated with higher quantities of antigen and adjuvant. CONCLUSION: A single vaccine dose containing 3.75 µg of A/California/7/2009 (H1N1) antigen with MF59 adjuvant was identified as optimal for young to middle-aged (18-64 years) and older (≥65 years) adult populations. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/25424947/A_dose_ranging_study_of_MF59_®__adjuvanted_and_non_adjuvanted_A/H1N1_pandemic_influenza_vaccine_in_young_to_middle_aged_and_older_adult_populations_to_assess_safety_immunogenicity_and_antibody_persistence_one_year_after_vaccination_ L2 - https://www.tandfonline.com/doi/full/10.4161/hv.29393 DB - PRIME DP - Unbound Medicine ER -