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

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 immun...

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Autores principales: DeZure, Adam D., Coates, Emily E., Hu, Zonghui, Yamshchikov, Galina V., Zephir, Kathryn L., Enama, Mary E., Plummer, Sarah H., Gordon, Ingelise J., Kaltovich, Florence, Andrews, Sarah, McDermott, Adrian, Crank, Michelle C., Koup, Richard A, Schwartz, Richard M., Bailer, Robert T., Sun, Xiangjie, Mascola, John R., Tumpey, Terrence M., Graham, Barney S., Ledgerwood, Julie E.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5627236/
https://www.ncbi.nlm.nih.gov/pubmed/29263871
http://dx.doi.org/10.1038/s41541-017-0016-6
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author DeZure, Adam D.
Coates, Emily E.
Hu, Zonghui
Yamshchikov, Galina V.
Zephir, Kathryn L.
Enama, Mary E.
Plummer, Sarah H.
Gordon, Ingelise J.
Kaltovich, Florence
Andrews, Sarah
McDermott, Adrian
Crank, Michelle C.
Koup, Richard A
Schwartz, Richard M.
Bailer, Robert T.
Sun, Xiangjie
Mascola, John R.
Tumpey, Terrence M.
Graham, Barney S.
Ledgerwood, Julie E.
author_facet DeZure, Adam D.
Coates, Emily E.
Hu, Zonghui
Yamshchikov, Galina V.
Zephir, Kathryn L.
Enama, Mary E.
Plummer, Sarah H.
Gordon, Ingelise J.
Kaltovich, Florence
Andrews, Sarah
McDermott, Adrian
Crank, Michelle C.
Koup, Richard A
Schwartz, Richard M.
Bailer, Robert T.
Sun, Xiangjie
Mascola, John R.
Tumpey, Terrence M.
Graham, Barney S.
Ledgerwood, Julie E.
author_sort DeZure, Adam D.
collection PubMed
description 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, p < 0.05) and Group 2 (GMT = 331, p = 0.02) when compared with Group 3 (GMT = 86.11). A novel H7 DNA vaccine was safe, well-tolerated, and immunogenic when boosted with H7N9 monovalent inactivated vaccine, while priming for higher HAI and neutralizing antibody titers than H7N9 monovalent inactivated vaccine alone.
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spelling pubmed-56272362017-12-20 An avian influenza H7 DNA priming vaccine is safe and immunogenic in a randomized phase I clinical trial DeZure, Adam D. Coates, Emily E. Hu, Zonghui Yamshchikov, Galina V. Zephir, Kathryn L. Enama, Mary E. Plummer, Sarah H. Gordon, Ingelise J. Kaltovich, Florence Andrews, Sarah McDermott, Adrian Crank, Michelle C. Koup, Richard A Schwartz, Richard M. Bailer, Robert T. Sun, Xiangjie Mascola, John R. Tumpey, Terrence M. Graham, Barney S. Ledgerwood, Julie E. NPJ Vaccines Article 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, p < 0.05) and Group 2 (GMT = 331, p = 0.02) when compared with Group 3 (GMT = 86.11). A novel H7 DNA vaccine was safe, well-tolerated, and immunogenic when boosted with H7N9 monovalent inactivated vaccine, while priming for higher HAI and neutralizing antibody titers than H7N9 monovalent inactivated vaccine alone. Nature Publishing Group UK 2017-06-01 /pmc/articles/PMC5627236/ /pubmed/29263871 http://dx.doi.org/10.1038/s41541-017-0016-6 Text en © The Author(s) 2017 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Article
DeZure, Adam D.
Coates, Emily E.
Hu, Zonghui
Yamshchikov, Galina V.
Zephir, Kathryn L.
Enama, Mary E.
Plummer, Sarah H.
Gordon, Ingelise J.
Kaltovich, Florence
Andrews, Sarah
McDermott, Adrian
Crank, Michelle C.
Koup, Richard A
Schwartz, Richard M.
Bailer, Robert T.
Sun, Xiangjie
Mascola, John R.
Tumpey, Terrence M.
Graham, Barney S.
Ledgerwood, Julie E.
An avian influenza H7 DNA priming vaccine is safe and immunogenic in a randomized phase I clinical trial
title An avian influenza H7 DNA priming vaccine is safe and immunogenic in a randomized phase I clinical trial
title_full An avian influenza H7 DNA priming vaccine is safe and immunogenic in a randomized phase I clinical trial
title_fullStr An avian influenza H7 DNA priming vaccine is safe and immunogenic in a randomized phase I clinical trial
title_full_unstemmed An avian influenza H7 DNA priming vaccine is safe and immunogenic in a randomized phase I clinical trial
title_short An avian influenza H7 DNA priming vaccine is safe and immunogenic in a randomized phase I clinical trial
title_sort avian influenza h7 dna priming vaccine is safe and immunogenic in a randomized phase i clinical trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5627236/
https://www.ncbi.nlm.nih.gov/pubmed/29263871
http://dx.doi.org/10.1038/s41541-017-0016-6
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