Randomized Comparison of Immunogenicity and Safety of Quadrivalent Recombinant Versus Inactivated Influenza Vaccine in Healthy Adults 18–49 Years of Age

• Published in: The Journal of infectious diseases Vol. 216; no. 10; pp. 1219 - 1226
• Main Authors: Dunkle, Lisa M., Izikson, Ruvim, Patriarca, Peter A., Goldenthal, Karen L., Muse, Derek, Cox, Manon M. J.
• Format: Journal Article
• Language: English
• Published: US Oxford University Press 05-12-2017
• Subjects: Adolescent; Adult; Antibody Formation - immunology; Female; Healthy Volunteers; Humans; Immunogenicity, Vaccine - immunology; Influenza A virus - immunology; Influenza Vaccines - administration & dosage; Influenza Vaccines - adverse effects; Influenza Vaccines - immunology; Influenza, Human - epidemiology; Influenza, Human - prevention & control; Male; Middle Aged; Vaccines, Inactivated - administration & dosage; Vaccines, Inactivated - adverse effects; Vaccines, Inactivated - immunology; Vaccines, Synthetic - administration & dosage; Vaccines, Synthetic - adverse effects; Vaccines, Synthetic - immunology; VIRUSES; Young Adult; recombinant influenza vaccine; Comparative immunogenicity; Flublok Quadrivalent
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1093/infdis/jix478

Randomized comparison of immunogenicity and safety of quadrivalent recombinant versus inactivated vaccine in young adults showed overall comparable antibody titers to vaccine strains, including higher responses to influenza A/H3N2 consistent with better efficacy previously reported in adults 50 or older.
Abstract
Background
Seasonal influenza vaccines are transitioning to quadrivalent formulations including the hemagglutinins of influenza A subtypes H1N1 and H3N2 and B lineages Yamagata and Victoria.
Methods
A new quadrivalent recombinant influenza vaccine (RIV4) was compared directly with a standard-dose, egg-grown, quadrivalent-inactivated influenza vaccine (IIV4) for immunogenicity and safety in adults 18–49 years of age. The coprimary endpoints for noninferiority were hemagglutination inhibition seroconversion rates and postvaccination geometric mean titer ratios for each antigen using US regulatory criteria. Reactogenicity solicited for 7 days, other safety events collected for 28 days, and serious or medically attended adverse events collected for 6 months after vaccination comprised the safety evaluation.
Results
The immunogenicity of RIV4 was comparable to that of IIV4; the coprimary noninferiority criteria were met for 3 antigens, and the antibody responses to the fourth antigen, influenza B/Brisbane/60/2008, were low in each group, making comparisons uninterpretable. Systemic and injection site reactions were mild, transient, and similar in each group, whereas none of the spontaneously reported adverse events, serious or nonserious, were considered related to study vaccine.
Conclusions
This first head-to-head comparison of recombinant versus inactivated quadrivalent influenza vaccines in 18–49 year old adults showed comparable immunogenicity, safety, and tolerability for both vaccines.