1. DNA vaccine priming for seasonal influenza vaccine in children and adolescents 6 to 17 years of age: A phase 1 randomized clinical trial.
- Author
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Katherine V Houser, Galina V Yamshchikov, Abbie R Bellamy, Jeanine May, Mary E Enama, Uzma Sarwar, Brenda Larkin, Robert T Bailer, Richard Koup, Myeisha Paskel, Kanta Subbarao, Edwin Anderson, David I Bernstein, Buddy Creech, Harry Keyserling, Paul Spearman, Peter F Wright, Barney S Graham, Julie E Ledgerwood, and VRC 702 study team
- Subjects
Medicine ,Science - Abstract
BACKGROUND:Children are susceptible to severe influenza infections and facilitate community transmission. One potential strategy to improve vaccine immunogenicity in children against seasonal influenza involves a trivalent hemagglutinin DNA prime-trivalent inactivated influenza vaccine (IIV3) boost regimen. METHODS:Sites enrolled adolescents, followed by younger children, to receive DNA prime (1 mg or 4 mg) intramuscularly by needle-free jet injector (Biojector), followed by split virus 2012/13 seasonal IIV3 boost by needle and syringe approximately 18 weeks later. A comparator group received IIV3 prime and boost at similar intervals. Primary study objectives included evaluation of the safety and tolerability of the vaccine regimens, with secondary objectives of measuring antibody responses at four weeks post boost by hemagglutination inhibition (HAI) and neutralization assays. RESULTS:Seventy-five children ≥6 to ≤17 years old enrolled. Local reactogenicity was higher after DNA prime compared to IIV3 prime (p
- Published
- 2018
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