ABSTRACT
Introduction: Influenza causes annual epidemics worldwide that pose a significant public health burden and current predominant vaccines, while the most effective means of combatting the disease, provide sub-optimal protection. New more broadly effective vaccines are an important public health need.
Areas covered: Influenza hemagglutinin (HA) is the principal viral surface protein that induces protective immunity to influenza infection. A recombinant seasonal influenza hemagglutinin (rHA) vaccine, recently introduced in the U.S., has demonstrated promising efficacy and safety in a number of clinical trials in adults. The immunodominant globular head of the HA protein induces antibodies that are narrowly specific to individual antigenically varied strains of influenza virus, resulting in poor affinity for antigenically drifted strains and the need for repeated annual vaccination. Broader spectrum protection may be achieved with immunity directed at more conserved viral antigens. We reviewed the data from clinical trials of the rHA vaccine conducted during seasonal epidemics characterized by antigenic mismatch between vaccine and circulating strains of influenza.
Expert commentary: These data suggest that the rHA proteins produced in Lepidopteran cells offer broader-spectrum protection and result in clinical benefit.
Acknowledgments
The studies addressed in this manuscript were conducted by multiple investigators at multiple sites in the US, each study under the overview of one of the following Institutional Review Boards.
Institutional Review Board for Baylor College of Medicine, Houston, TX
Cincinnati Children’s Hospital Medical Center Institutional Review Board, Cincinnati, OH
Kaiser Permanente Institutional Review Board for the Protection of Human Subjects, Honolulu, HI
Institutional Review Board for the Protection of Human Subjects, Kaiser Foundation Research Institute, Oakland, CA
Marshfield Clinic Research Foundation’s IRB, Marshfield, WI
University of Maryland Baltimore Institutional Review Board, Baltimore, Maryland
Mayo Clinic Institutional Review Boards, Rochester, Minnesota
Quorum Institutional Review Board, Seattle, WA
University of Rochester Research Subject Review Board, Rochester, NY
St. Louis University Institutional Review Board, St. Louis, MO
Vanderbilt University Institutional Review Board, Nashville, TN
Human Investigation Committee, University of Virginia, Charlottesville, VA
Western Institutional Review Board, Olympia, WA
Declaration of interest
LM Dunkle is an employee, shareholder and Chief Medical Officer for Protein Sciences Corporation. R Izikson is an employee and Director of Clinical Operations for Protein Sciences Corporation. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.