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Open Forum Infect Dis. 2019 Mar 1;6(4):ofz107. doi: 10.1093/ofid/ofz107. eCollection 2019 Apr.
Safety and Immunogenicity of MF59-Adjuvanted Cell Culture-Derived A/H5N1 Subunit Influenza Virus Vaccine: Dose-Finding Clinical Trials in Adults and the Elderly.
Frey SE1, Shakib S2, Chanthavanich P3, Richmond P4, Smith T5, Tantawichien T6, Kittel C7, Jaehnig P7, Mojares Z8, Verma B9, Kanesa-Thasan N9, Hohenboken M10.
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Abstract
Background:
A/H5N1 influenza viruses have high pandemic potential; consequently, vaccines need to be produced rapidly. MF59? adjuvant reduces the antigen required per dose, allowing for dose sparing and more rapid vaccine availability.
Methods:
Two multicenter, phase II trials were conducted to evaluate the safety and immunogenicity of an MF59-adjuvanted, cell culture-derived, A/H5N1 vaccine (aH5N1c) among 979 adult (18-64 years old) and 1393 elderly (≥65 years old) subjects. Participants were equally randomized to receive 2 full-dose (7.5 μg of hemagglutinin antigen per dose) or 2 half-dose aH5N1c vaccinations 3 weeks apart. Outcomes were based on Center for Biologics Evaluation Research and Review (CBER) and Committee for Medicinal Products for Human Use (CHMP) licensure criteria (titers ≥1:40 and seroconversions on day 43). Solicited reactions and adverse events were assessed (www.clinicaltrials.gov: NCT01776541 and NCT01766921).
Results:
CBER and CHMP criteria were met by both age groups. CBER criteria for hemagglutination titers were met for the full-dose formulation. Solicited reaction frequencies tended to be higher in the full-dose group and were of mild to moderate intensity. No vaccine-related serious adverse events occurred.
Conclusions:
In adult and elderly participants, the full-dose aH5N1c vaccine formulation was well tolerated and met US and European licensure criteria for pandemic vaccines.
KEYWORDS:
H5N1 subunit vaccine; MF59 adjuvant; pandemic influenza; cell culture?derived vaccine; influenza; phase II
PMID: 30968056 PMCID: PMC6446137 DOI: 10.1093/ofid/ofz107
Free PMC Article
Safety and Immunogenicity of MF59-Adjuvanted Cell Culture-Derived A/H5N1 Subunit Influenza Virus Vaccine: Dose-Finding Clinical Trials in Adults and the Elderly.
Frey SE1, Shakib S2, Chanthavanich P3, Richmond P4, Smith T5, Tantawichien T6, Kittel C7, Jaehnig P7, Mojares Z8, Verma B9, Kanesa-Thasan N9, Hohenboken M10.
Author information
Abstract
Background:
A/H5N1 influenza viruses have high pandemic potential; consequently, vaccines need to be produced rapidly. MF59? adjuvant reduces the antigen required per dose, allowing for dose sparing and more rapid vaccine availability.
Methods:
Two multicenter, phase II trials were conducted to evaluate the safety and immunogenicity of an MF59-adjuvanted, cell culture-derived, A/H5N1 vaccine (aH5N1c) among 979 adult (18-64 years old) and 1393 elderly (≥65 years old) subjects. Participants were equally randomized to receive 2 full-dose (7.5 μg of hemagglutinin antigen per dose) or 2 half-dose aH5N1c vaccinations 3 weeks apart. Outcomes were based on Center for Biologics Evaluation Research and Review (CBER) and Committee for Medicinal Products for Human Use (CHMP) licensure criteria (titers ≥1:40 and seroconversions on day 43). Solicited reactions and adverse events were assessed (www.clinicaltrials.gov: NCT01776541 and NCT01766921).
Results:
CBER and CHMP criteria were met by both age groups. CBER criteria for hemagglutination titers were met for the full-dose formulation. Solicited reaction frequencies tended to be higher in the full-dose group and were of mild to moderate intensity. No vaccine-related serious adverse events occurred.
Conclusions:
In adult and elderly participants, the full-dose aH5N1c vaccine formulation was well tolerated and met US and European licensure criteria for pandemic vaccines.
KEYWORDS:
H5N1 subunit vaccine; MF59 adjuvant; pandemic influenza; cell culture?derived vaccine; influenza; phase II
PMID: 30968056 PMCID: PMC6446137 DOI: 10.1093/ofid/ofz107
Free PMC Article