Safety and immunogenicity of investigational seasonal influenza hemagglutinin DNA vaccine followed by trivalent inactivated vaccine administered intradermally or intramuscularly in healthy adults: An open-label randomized phase 1 clinical trial
Autoři:
Cristina Carter aff001; Katherine V. Houser aff001; Galina V. Yamshchikov aff001; Abbie R. Bellamy aff002; Jeanine May aff002; Mary E. Enama aff001; Uzma Sarwar aff001; Brenda Larkin aff001; Robert T. Bailer aff001; Richard Koup aff001; Grace L. Chen aff001; Shital M. Patel aff003; Patricia Winokur aff004; Robert Belshe aff005; Cornelia L. Dekker aff006; Barney S. Graham aff001; Julie E. Ledgerwood aff001;
Působiště autorů:
Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States of America
aff001; The Emmes Corporation, Rockville, MD, United States of America
aff002; Departments of Medicine and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, United States of America
aff003; Department of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City, IA, United States of America
aff004; Division of Infectious Diseases, Allergy and Immunology, Saint Louis University, St. Louis, MO, United States of America
aff005; Department of Pediatrics (Infectious Diseases), Stanford University Medical Center, Stanford, CA, United States of America
aff006
Vyšlo v časopise:
PLoS ONE 14(9)
Kategorie:
Research Article
doi:
https://doi.org/10.1371/journal.pone.0222178
Souhrn
Background
Seasonal influenza results in significant morbidity and mortality worldwide, but the currently licensed inactivated vaccines generally have low vaccine efficacies and could be improved. In this phase 1 clinical trial, we compared seasonal influenza vaccine regimens with different priming strategies, prime-boost intervals, and administration routes to determine the impact of these variables on the resulting antibody response.
Methods
Between August 17, 2012 and January 25, 2013, four sites enrolled healthy adults 18–70 years of age. Subjects were randomized to receive one of the following vaccination regimens: trivalent hemagglutinin (HA) DNA prime followed by trivalent inactivated influenza vaccine (IIV3) boost with a 3.5 month interval (DNA-IIV3), IIV3 prime followed by IIV3 boost with a 10 month interval (IIV3-IIV3), or concurrent DNA and IIV3 prime followed by IIV3 boost with a 10 month interval (DNA/IIV3-IIV3). Each regimen was additionally stratified by an IIV3 administration route of either intramuscular (IM) or intradermal (ID). DNA vaccines were administered by a needle-free jet injector (Biojector). Study objectives included evaluating the safety and tolerability of each regimen and measuring the antibody response by hemagglutination inhibition (HAI).
Results
Three hundred and sixteen subjects enrolled. Local reactogenicity was mild to moderate in severity, with higher frequencies recorded following DNA vaccine administered by Biojector compared to IIV3 by either route (p <0.02 for pain, swelling, and redness) and following IIV3 by ID route compared to IM route (p <0.001 for swelling and redness). Systemic reactogenicity was similar between regimens. Though no overall differences were observed between regimens, the highest titers post boost were observed in the DNA-IIV3 group by ID route and in the IIV3-IIV3 group by IM route.
Conclusions
All vaccination regimens were found to be safe and tolerable. While there were no overall differences between regimens, the DNA-IIV3 group by ID route, and the IIV3-IIV3 group by IM route, showed higher responses compared to the other same-route regimens.
Klíčová slova:
Biology and life sciences – Antibody response – Antibodies – Vaccination and immunization – DNA vaccination – Physiology – Biochemistry – Proteins – Immune system proteins – Medicine and health sciences – Immunology – Immune response – Infectious diseases – Infectious disease control – Vaccines – Viral diseases – Influenza – Pharmacology – Routes of administration – Immune physiology – Public and occupational health – Preventive medicine – People and places – Population groupings – Age groups – Elderly
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