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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.

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.

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

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