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.
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 -