Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults.

Nature
Mark J MulliganKathrin U Jansen

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 n...Continue Reading

References

Jan 1, 1997·Annual Review of Immunology·M F Bachmann, R M Zinkernagel
Mar 23, 2004·Journal of Molecular Biology·Sarah GütheThomas Kiefhaber
Jul 22, 2004·The Journal of Immunology : Official Journal of the American Association of Immunologists·Graham R FosterFederica M Marelli-Berg
Sep 18, 2008·Molecular Therapy : the Journal of the American Society of Gene Therapy·Katalin KarikóDrew Weissman
Sep 23, 2014·Nature Reviews. Drug Discovery·Ugur SahinÖzlem Türeci
Mar 6, 2015·JAMA : the Journal of the American Medical Association·Lilin LaiMark J Mulligan
Apr 2, 2015·The New England Journal of Medicine·Jason A RegulesUNKNOWN rVSVΔG-ZEBOV-GP Study Group
Aug 13, 2015·Journal of Controlled Release : Official Journal of the Controlled Release Society·Norbert PardiDrew Weissman
Oct 5, 2018·Frontiers in Immunology·Susanne RauchBenjamin Petsch
Apr 15, 2020·Cell Host & Microbe·Xuping XiePei-Yong Shi
Jun 20, 2020·MMWR. Morbidity and Mortality Weekly Report·Erin K StokesKathleen E Fullerton
Aug 15, 2020·Nature Communications·Antonio E MuruatoPei-Yong Shi
Aug 26, 2020·MedRxiv : the Preprint Server for Health Sciences·Edward E WalshWilliam C Gruber

❮ Previous
Next ❯

Citations

Sep 3, 2020·The New England Journal of Medicine·Cheryl KeechGregory M Glenn
Sep 25, 2020·Current Opinion in HIV and AIDS·Yihan WangDongming Zhou
Sep 25, 2020·Current Opinion in HIV and AIDS·Xin LiJasper Fuk-Woo Chan
Sep 24, 2020·Nature·Florian Krammer
Aug 15, 2020·Nature Communications·Antonio E MuruatoPei-Yong Shi
Aug 26, 2020·Nature Medicine·Kathryn M Edwards
Sep 11, 2020·The Journal of Experimental Medicine·Ting ZhouJun Wang
Sep 6, 2020·Nature Reviews. Immunology·Mangalakumari JeyanathanZhou Xing
Oct 13, 2020·Frontiers in Microbiology·Yuki Furuse, Hitoshi Oshitani
Oct 18, 2020·Nature Reviews. Microbiology·Shan SuShibo Jiang
Oct 21, 2020·Nature·Christian Gaebler, Michel C Nussenzweig
Oct 15, 2020·Signal Transduction and Targeted Therapy·Yetian DongFangfang Zhou
Oct 31, 2020·Wiener klinische Wochenschrift·Franz X Heinz, Karin Stiasny
Nov 6, 2020·Médecine sciences : M/S·Emmanuelle Billon-Denis, Jean-Nicolas Tournier
Oct 29, 2020·Pediatric Allergy and Immunology : Official Publication of the European Society of Pediatric Allergy and Immunology·Christiane Sigrid Eberhardt, Claire-Anne Siegrist
Oct 28, 2020·Nature·Jessica A PlantePei-Yong Shi
Nov 29, 2020·Signal Transduction and Targeted Therapy·Zezhong LiuShibo Jiang
Oct 29, 2020·International Journal of Clinical Practice·Timothy Cardozo, Ronald Veazey
Dec 9, 2020·British Journal of Cancer·Raphaelle FanciullinoGerard Milano
Dec 10, 2020·Nature Biomedical Engineering·Norbert Pardi, Drew Weissman
Dec 16, 2020·SLAS Discovery·Dawid MaciorowskiAdinarayana Kunamneni
Dec 19, 2020·Journal of Interferon & Cytokine Research : the Official Journal of the International Society for Interferon and Cytokine Research·Hongjie Xia, Pei-Yong Shi
Dec 30, 2020·Physiological Reports·Mukulika BosePinku Mukherjee
Jan 8, 2021·Cell·Wilfredo F Garcia-BeltranAlejandro B Balazs
Dec 12, 2020·International Immunopharmacology·Hyun Jee HanSan Kim
Jan 12, 2021·Advanced Drug Delivery Reviews·Jatin MachhiBhavesh D Kevadiya
Jan 14, 2021·Journal of Biomedical Science·Ioannis P TrougakosMeletios A Dimopoulos
Jan 14, 2021·The New England Journal of Medicine·Jerald SadoffHanneke Schuitemaker
Jan 12, 2021·The Journal of Biological Chemistry·Sameer Kumar MalladiRaghavan Varadarajan
Nov 21, 2020·Clinical Immunology : the Official Journal of the Clinical Immunology Society·Vladislav IzdaAmr H Sawalha
Jan 6, 2021·Advanced Drug Delivery Reviews·Jeonghwan KimGaurav Sahay
Dec 20, 2020·Advanced Drug Delivery Reviews·Kyung Soo ParkJames J Moon
Jan 27, 2021·Cells·Rameswari Chilamakuri, Saurabh Agarwal
Jan 23, 2021·Vaccines·Alberto Cagigi, Karin Loré
Jan 27, 2021·Vaccines·Larisa I KarpenkoAlexander A Ilyichev
Nov 3, 2020·Canadian Journal of Microbiology·Marina Liu, Xiongbiao Chen
Jan 11, 2021·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·Michele CarboneEnrico Bucci
Nov 24, 2020·Biomedicine & Pharmacotherapy = Biomédecine & Pharmacothérapie·Bianza Moise BakadiaGuang Yang
Feb 4, 2021·Clinical Nurse Specialist CNS·Patricia O'Malley

❮ Previous
Next ❯

Datasets Mentioned

BETA
MN908947.3

Methods Mentioned

BETA
nucleic acid amplification
PCR

Clinical Trials Mentioned

NCT04368728

Software Mentioned

GraphPad Prism
Gen5 Image Prime

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.