MedicalResearch.com Interview with:
Lisa M. Dunkle, M.D.
Chief Medical Officer
Protein Sciences Corporation
1000 Research Parkway
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The first and only recombinant protein influenza vaccine (RIV, Flublok) was approved in 2013 as a trivalent formulation for use in adults 18 years of age and older. This approval was based on demonstration of clinical efficacy (full approval) in adults 18-49 years of age and accelerated approval was granted for adults 50 years of age and older. Two clinical trials were conducted in 2014-2015 with RIV4 (Flublok Quadrivalent), of which the trial reported in the current NEJM is one.
These studies supported full approval of Flublok in adults 50 years of age and older and approval of Flublok Quadrivalent in all adults 18 years of age and older. The second trial of immunogenicity of Flublok Quadrivalent in adults 18-49 years of age will be the subject of another publication in the near future.
The main findings of the current trial are well summarized in the Conclusion of the Abstract: “RIV4 provided better protection than standard-dose IIV4 against confirmed influenza-like illness in older adults.”
Additionally, the recombinant vaccine (RIV4, Flublok Quadrivalent) demonstrated significantly less injection site pain and tenderness following vaccination. Based on the characteristics of the study participants, one can conclude that RIV4 is safe and effective in most individuals with underlying chronic diseases
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: The most important “take-away” message for readers is that there is a choice when asking for an influenza vaccine, and that Flublok Quadrivalent (RIV4) is the better choice because it provides better protection with less injection site reaction than the conventional, standard dose inactivated influenza vaccine (IIV4). As older adults often less well protected by vaccination than younger adults, these study results show promise for all adults 18 years of age and older.
The modern recombinant manufacturing process used for production of Flublok yields a pure hemagglutinin protein vaccine with no egg protein, antibiotics, formaldehyde or other undesirable components.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: This study makes it clear that RIV4 (Flublok Quadrivalent) is better than standard dose inactivated vaccine (IIV4). An important question to be addressed is how Flublok Quadrivalent compares with other “specialized” vaccines designed for older adults, and how vaccine efficacy is affected by year-after-year vaccination.
These questions are being addressed in a CDC-sponsored trial beginning initiated this fall in Hong Kong. Participants will receive Flublok Quadrivalent, Fluzone High-Dose, Fluad (adjuvanted inactivated vaccine) or standard dose inactivated vaccine (IIV4). Protective efficacy will be measure during the first season of follow-up and in the second season after participants have received the same or another of the four vaccines. It’s a complicated study, but promises to give some valuable insight into the best prevention of influenza in elderly adults.
MedicalResearch.com: Is there anything else you would like to add?
Response: This study was conducted by 40 clinical investigators across the United States who are represented in the authorship specifically by their co-investigator, Dr. Derek Muse. The remainder of the authors, on behalf of the entire Study Team, contributed to study design and interpretation and production of the manuscript.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Efficacy of Recombinant Influenza Vaccine in Adults 50 Years of Age or Older
Lisa M. Dunkle, M.D., Ruvim Izikson, M.D., M.P.H., Peter Patriarca, M.D., Karen L. Goldenthal, M.D., Derek Muse, M.D., Janice Callahan, Ph.D., and Manon M.J. Cox, Ph.D., for the PSC12 Study Team*
N Engl J Med 2017;376:2427-36.
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.