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DeZure AD, Coates EE, Hu Z, et al. An avian influenza H7 DNA priming vaccine is safe and immunogenic in a randomized phase I clinical trial. NPJ Vaccines. 2017;2:15doi: 10.1038/s41541-017-0016-6.
DeZure, A. D., Coates, E. E., Hu, Z., Yamshchikov, G. V., Zephir, K. L., Enama, M. E., Plummer, S. H., Gordon, I. J., Kaltovich, F., Andrews, S., McDermott, A., Crank, M. C., Koup, R. A., Schwartz, R. M., Bailer, R. T., Sun, X., Mascola, J. R., Tumpey, T. M., Graham, B. S., & Ledgerwood, J. E. (2017). An avian influenza H7 DNA priming vaccine is safe and immunogenic in a randomized phase I clinical trial. NPJ vaccines, 215. https://doi.org/10.1038/s41541-017-0016-6
DeZure, Adam D, et al. "An avian influenza H7 DNA priming vaccine is safe and immunogenic in a randomized phase I clinical trial." NPJ vaccines vol. 2 (2017): 15. doi: https://doi.org/10.1038/s41541-017-0016-6
DeZure AD, Coates EE, Hu Z, Yamshchikov GV, Zephir KL, Enama ME, Plummer SH, Gordon IJ, Kaltovich F, Andrews S, McDermott A, Crank MC, Koup RA, Schwartz RM, Bailer RT, Sun X, Mascola JR, Tumpey TM, Graham BS, Ledgerwood JE. An avian influenza H7 DNA priming vaccine is safe and immunogenic in a randomized phase I clinical trial. NPJ Vaccines. 2017 Jun 01;2:15. doi: 10.1038/s41541-017-0016-6. eCollection 2017. PMID: 29263871; PMCID: PMC5627236.
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NPJ Vaccines. 2017 Jun 01;2:15. doi: 10.1038/s41541-017-0016-6. eCollection 2017.

An avian influenza H7 DNA priming vaccine is safe and immunogenic in a randomized phase I clinical trial.

NPJ vaccines

Adam D DeZure, Emily E Coates, Zonghui Hu, Galina V Yamshchikov, Kathryn L Zephir, Mary E Enama, Sarah H Plummer, Ingelise J Gordon, Florence Kaltovich, Sarah Andrews, Adrian McDermott, Michelle C Crank, Richard A Koup, Richard M Schwartz, Robert T Bailer, Xiangjie Sun, John R Mascola, Terrence M Tumpey, Barney S Graham, Julie E Ledgerwood

Affiliations

  1. Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892 USA.
  2. Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892 USA.
  3. Present Address: Synlogic, Cambridge, MA 02139 USA.
  4. Influenza Division, National Center for Immunization and Respiratory Diseases, US Centers for Disease Control and Prevention, Atlanta, GA USA.

PMID: 29263871 PMCID: PMC5627236 DOI: 10.1038/s41541-017-0016-6

Abstract

A novel avian influenza subtype, A/H7N9, emerged in 2013 and represents a public health threat with pandemic potential. We have previously shown that DNA vaccine priming increases the magnitude and quality of antibody responses to H5N1 monovalent inactivated boost. We now report the safety and immunogenicity of a H7 DNA-H7N9 monovalent inactivated vaccine prime-boost regimen. In this Phase 1, open label, randomized clinical trial, we evaluated three H7N9 vaccination regimens in healthy adults, with a prime-boost interval of 16 weeks. Group 1 received H7 DNA vaccine prime and H7N9 monovalent inactivated vaccine boost. Group 2 received H7 DNA and H7N9 monovalent inactivated vaccine as a prime and H7N9 monovalent inactivated vaccine as a boost. Group 3 received H7N9 monovalent inactivated vaccine in a homologous prime-boost regimen. Overall, 30 individuals between 20 to 60 years old enrolled and 28 completed both vaccinations. All injections were well tolerated with no serious adverse events. 2 weeks post-boost, 50% of Group 1 and 33% of Group 2 achieved a HAI titer ≥1:40 compared with 11% of Group 3. Also, at least a fourfold increase in neutralizing antibody responses was seen in 90% of Group 1, 100% of Group 2, and 78% of Group 3 subjects. Peak neutralizing antibody geometric mean titers were significantly greater for Group 1 (GMT = 440.61,

Conflict of interest statement

The authors declare that they have no competing financial interests.

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