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Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults.
Nature. 2020 Aug 12 [Online ahead of print]Nat

Abstract

In March 2020, the World Health Organization (WHO) declared a pandemic of coronavirus disease 2019 (COVID-19), due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1. With rapidly accumulating cases and deaths reported globally2, a vaccine is urgently needed. We report the available safety, tolerability, and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose escalation study among 45 healthy adults, 18 to 55 years of age, randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD). Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. A second vaccination with 100 µg was not administered due to increased reactogenicity and a lack of meaningfully increased immunogenicity after a single dose compared to the 30 μg dose. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers in sera increased with dose level and after a second dose. Geometric mean neutralizing titers reached 1.9- to 4.6-fold that of a panel of COVID-19 convalescent human sera at least 14 days after a positive SARS-CoV-2 PCR. These results support further evaluation of this mRNA vaccine candidate. (ClinicalTrials.gov identifier: NCT04368728).

Authors+Show Affiliations

New York University Langone Vaccine Center, New York, NY, USA. New York University Grossman School of Medicine, New York, NY, USA.University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore, MD, USA.Vaccine Research and Development, Pfizer Inc, Hurley, UK.Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA. judith.absalon@pfizer.com.Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.Vaccine Research and Development, Pfizer Inc, Hurley, UK.University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore, MD, USA.New York University Langone Vaccine Center, New York, NY, USA. New York University Grossman School of Medicine, New York, NY, USA.Vaccine Research and Development, Pfizer Inc, Hurley, UK.Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.University of Texas Medical Branch, Galveston, TX, USA.University of Texas Medical Branch, Galveston, TX, USA.BioNTech, Mainz, Germany.Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.University of Rochester, Rochester, NY, USA. Rochester General Hospital, Rochester, NY, USA.Cincinnati Children's Hospital, Cincinnati, OH, USA.University of Rochester, Rochester, NY, USA. Rochester General Hospital, Rochester, NY, USA.Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.BioNTech, Mainz, Germany.Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32785213

Citation

Mulligan, Mark J., et al. "Phase 1/2 Study of COVID-19 RNA Vaccine BNT162b1 in Adults." Nature, 2020.
Mulligan MJ, Lyke KE, Kitchin N, et al. Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults. Nature. 2020.
Mulligan, M. J., Lyke, K. E., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Neuzil, K., Raabe, V., Bailey, R., Swanson, K. A., Li, P., Koury, K., Kalina, W., Cooper, D., Fontes-Garfias, C., Shi, P. Y., Türeci, Ö., Tompkins, K. R., Walsh, E. E., ... Jansen, K. U. (2020). Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults. Nature. https://doi.org/10.1038/s41586-020-2639-4
Mulligan MJ, et al. Phase 1/2 Study of COVID-19 RNA Vaccine BNT162b1 in Adults. Nature. 2020 Aug 12; PubMed PMID: 32785213.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults. AU - Mulligan,Mark J, AU - Lyke,Kirsten E, AU - Kitchin,Nicholas, AU - Absalon,Judith, AU - Gurtman,Alejandra, AU - Lockhart,Stephen, AU - Neuzil,Kathleen, AU - Raabe,Vanessa, AU - Bailey,Ruth, AU - Swanson,Kena A, AU - Li,Ping, AU - Koury,Kenneth, AU - Kalina,Warren, AU - Cooper,David, AU - Fontes-Garfias,Camila, AU - Shi,Pei-Yong, AU - Türeci,Özlem, AU - Tompkins,Kristin R, AU - Walsh,Edward E, AU - Frenck,Robert, AU - Falsey,Ann R, AU - Dormitzer,Philip R, AU - Gruber,William C, AU - Şahin,Uğur, AU - Jansen,Kathrin U, Y1 - 2020/08/12/ PY - 2020/06/29/received PY - 2020/08/04/accepted PY - 2020/8/14/entrez JF - Nature JO - Nature N2 - In March 2020, the World Health Organization (WHO) declared a pandemic of coronavirus disease 2019 (COVID-19), due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1. With rapidly accumulating cases and deaths reported globally2, a vaccine is urgently needed. We report the available safety, tolerability, and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose escalation study among 45 healthy adults, 18 to 55 years of age, randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD). Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. A second vaccination with 100 µg was not administered due to increased reactogenicity and a lack of meaningfully increased immunogenicity after a single dose compared to the 30 μg dose. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers in sera increased with dose level and after a second dose. Geometric mean neutralizing titers reached 1.9- to 4.6-fold that of a panel of COVID-19 convalescent human sera at least 14 days after a positive SARS-CoV-2 PCR. These results support further evaluation of this mRNA vaccine candidate. (ClinicalTrials.gov identifier: NCT04368728). SN - 1476-4687 UR - https://www.unboundmedicine.com/medline/citation/32785213/full_citation L2 - https://doi.org/10.1038/s41586-020-2639-4 DB - PRIME DP - Unbound Medicine ER -
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