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Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults.
Nature. 2020 10; 586(7830):589-593.Nat

Abstract

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

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Authors+Show Affiliations

Mulligan MJ
New York University Langone Vaccine Center, New York, NY, USA. New York University Grossman School of Medicine, New York, NY, USA.
Lyke KE
University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore, MD, USA.
Kitchin N
Vaccine Research and Development, Pfizer Inc, Hurley, UK.
Absalon J
Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA. judith.absalon@pfizer.com.
Gurtman A
Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Lockhart S
Vaccine Research and Development, Pfizer Inc, Hurley, UK.
Neuzil K
University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore, MD, USA.
Raabe V
New York University Langone Vaccine Center, New York, NY, USA. New York University Grossman School of Medicine, New York, NY, USA.
Bailey R
Vaccine Research and Development, Pfizer Inc, Hurley, UK.
Swanson KA
Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Li P
Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
Koury K
Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Kalina W
Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Cooper D
Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Fontes-Garfias C
University of Texas Medical Branch, Galveston, TX, USA.
Shi PY
University of Texas Medical Branch, Galveston, TX, USA.
Türeci Ö
BioNTech, Mainz, Germany.
Tompkins KR
Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Walsh EE
University of Rochester, Rochester, NY, USA. Rochester General Hospital, Rochester, NY, USA.
Frenck R
Cincinnati Children's Hospital, Cincinnati, OH, USA.
Falsey AR
University of Rochester, Rochester, NY, USA. Rochester General Hospital, Rochester, NY, USA.
Dormitzer PR
Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Gruber WC
Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Şahin U
BioNTech, Mainz, Germany.
Jansen KU
Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.

MeSH

AdultAntibodies, NeutralizingAntibodies, ViralCOVID-19COVID-19 VaccinesCoronavirus InfectionsFemaleHumansImmunization, PassiveImmunoglobulin GMaleMiddle AgedPandemicsPneumonia, ViralSpike Glycoprotein, CoronavirusTime FactorsViral VaccinesYoung Adult

Pub Type(s)

Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

32785213

Clinical Trial Links

Clinical trial which this article describes

Citation

Mulligan, Mark J., et al. "Phase I/II Study of COVID-19 RNA Vaccine BNT162b1 in Adults." Nature, vol. 586, no. 7830, 2020, pp. 589-593.
Mulligan MJ, Lyke KE, Kitchin N, et al. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature. 2020;586(7830):589-593.
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 I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature, 586(7830), 589-593. https://doi.org/10.1038/s41586-020-2639-4
Mulligan MJ, et al. Phase I/II Study of COVID-19 RNA Vaccine BNT162b1 in Adults. Nature. 2020;586(7830):589-593. PubMed PMID: 32785213.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase I/II 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/pubmed PY - 2020/10/30/medline PY - 2020/8/14/entrez SP - 589 EP - 593 JF - Nature JO - Nature VL - 586 IS - 7830 N2 - In March 2020, the World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1, a pandemic. With rapidly accumulating numbers of cases and deaths reported globally2, a vaccine is urgently needed. Here we report the available safety, tolerability and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose-escalation study (ClinicalTrials.gov identifier NCT04368728) among 45 healthy adults (18-55 years of age), who were randomized to receive 2 doses-separated by 21 days-of 10 μg, 30 μg or 100 μg of BNT162b1. BNT162b1 is a lipid-nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes the trimerized receptor-binding domain (RBD) of the spike glycoprotein of SARS-CoV-2. Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. A second vaccination with 100 μg was not administered because of the increased reactogenicity and a lack of meaningfully increased immunogenicity after a single dose compared with the 30-μg dose. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titres in sera increased with dose level and after a second dose. Geometric mean neutralizing titres reached 1.9-4.6-fold that of a panel of COVID-19 convalescent human sera, which were obtained at least 14 days after a positive SARS-CoV-2 PCR. These results support further evaluation of this mRNA vaccine candidate. 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 -