tetano
Editor, Senior Moderator
Open Forum Infect Dis. 2019 Mar 1;6(4)
fz107. doi: 10.1093/ofid/ofz107. eCollection 2019 Apr.
[h=1]Safety and Immunogenicity of MF59-Adjuvanted Cell Culture-Derived A/H5N1 Subunit Influenza Virus Vaccine: Dose-Finding Clinical Trials in Adults and the Elderly.[/h] Frey SE[SUP]1[/SUP], Shakib S[SUP]2[/SUP], Chanthavanich P[SUP]3[/SUP], Richmond P[SUP]4[/SUP], Smith T[SUP]5[/SUP], Tantawichien T[SUP]6[/SUP], Kittel C[SUP]7[/SUP], Jaehnig P[SUP]7[/SUP], Mojares Z[SUP]8[/SUP], Verma B[SUP]9[/SUP], Kanesa-Thasan N[SUP]9[/SUP], Hohenboken M[SUP]10[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]Background:[/h] 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.
[h=4]Methods:[/h] 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).
[h=4]Results:[/h] 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.
[h=4]Conclusions:[/h] In adult and elderly participants, the full-dose aH5N1c vaccine formulation was well tolerated and met US and European licensure criteria for pandemic vaccines.
[h=4]KEYWORDS:[/h] 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
fz107. doi: 10.1093/ofid/ofz107. eCollection 2019 Apr.[h=1]Safety and Immunogenicity of MF59-Adjuvanted Cell Culture-Derived A/H5N1 Subunit Influenza Virus Vaccine: Dose-Finding Clinical Trials in Adults and the Elderly.[/h] Frey SE[SUP]1[/SUP], Shakib S[SUP]2[/SUP], Chanthavanich P[SUP]3[/SUP], Richmond P[SUP]4[/SUP], Smith T[SUP]5[/SUP], Tantawichien T[SUP]6[/SUP], Kittel C[SUP]7[/SUP], Jaehnig P[SUP]7[/SUP], Mojares Z[SUP]8[/SUP], Verma B[SUP]9[/SUP], Kanesa-Thasan N[SUP]9[/SUP], Hohenboken M[SUP]10[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]Background:[/h] 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.
[h=4]Methods:[/h] 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).
[h=4]Results:[/h] 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.
[h=4]Conclusions:[/h] In adult and elderly participants, the full-dose aH5N1c vaccine formulation was well tolerated and met US and European licensure criteria for pandemic vaccines.
[h=4]KEYWORDS:[/h] 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