[Source: US National Library of Medicine, full page: (LINK). Abstract, edited.]
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.
Author information: 1 School of Medicine, Saint Louis University, St. Louis, Missouri. 2 CMAX Clinical Research Pty Ltd., Adelaide, SA, Australia. 3 Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. 4 Division of Paediatrics, School of Medicine, University of Western Australia, and Vaccine Trials Group, Telethon Kids Institute, Subiaco, WA, Australia. 5 Mercy Health Research, St. Louis, Missouri. 6 Department of Medicine, Faculty of Medicine, Chulalongkorn University and Queen Saovabha Memorial Institute, Bangkok, Thailand. 7 GlaxoSmithKline Vaccines GmbH, Marburg, Germany. 8 GlaxoSmithKline Pte Ltd., Singapore, Singapore. 9 GlaxoSmithKline Vaccines LLC, Rockville, Maryland. 10 Seqirus Inc., Cambridge, Massachusetts.
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.
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).
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.
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
Keywords: Avian Influenza; H5N1; Vaccines.