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First report demonstrating the safety and immunogenicity of the SARS-COV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, observer-blind Phase I study
Fengcai Zhu
NHC Key laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention; Center for Global Health, Nanjing Medical University
Corresponding Author
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An effective vaccine is needed to end the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic. Data from the U.S. NCT04368728 and German EudraCT 2020-001038-36 vaccine trials was recently reported, showing the safety, tolerability, and antibody response of the BNT162b1 vaccine candidate. BNT162b1 encodes the SARS-CoV-2 spike glycoprotein receptor-binding domain and is one of several RNA-based SARS-CoV-2 vaccine candidates under study. Here, we report preliminary results from a Phase I trial testing BNT162b1 in 144 healthy Chinese participants. The safety profile was broadly comparable to that seen in the American and German trials, with fever the only Grade 3 adverse event reported. Prime-boost vaccination with 10 µg or 30 µg BNT162b1 induced robust antibody responses in both younger (18 to 55 years of age) and older (65 to 85) Chinese adults, and interferon-γ T-cell responses to RBD antigen challenge were significantly higher in participants receiving BNT162b1 than those in placebo groups. The 30 µg dose induced increased reactogenicity as well as a more favorable vaccine-elicited virus-neutralizing response than the 10 µg dose in both younger and older Chinese adults. In conclusion, this first report of an mRNA vaccine in an Asian population showed similar results to BNT162b1 trials.
This trial was funded by Fosun and BioNTech and registered under ChiCTR2000034825 and NCT04523571.
Keywords
SARS-CoV-2, vaccine, immunogenicity
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This preprint is under consideration at a Nature Portfolio Journal. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Nature journals have partnered with Research Square to offer In Review, a journal-integrated preprint deposition service.
Article
First report demonstrating the safety and immunogenicity of the SARS-COV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, observer-blind Phase I study
Fengcai Zhu
NHC Key laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention; Center for Global Health, Nanjing Medical University
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 08 Jan, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Infectious Diseases
License:
This work is licensed under a CC BY 4.0 License. Read Full License
An effective vaccine is needed to end the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic. Data from the U.S. NCT04368728 and German EudraCT 2020-001038-36 vaccine trials was recently reported, showing the safety, tolerability, and antibody response of the BNT162b1 vaccine candidate. BNT162b1 encodes the SARS-CoV-2 spike glycoprotein receptor-binding domain and is one of several RNA-based SARS-CoV-2 vaccine candidates under study. Here, we report preliminary results from a Phase I trial testing BNT162b1 in 144 healthy Chinese participants. The safety profile was broadly comparable to that seen in the American and German trials, with fever the only Grade 3 adverse event reported. Prime-boost vaccination with 10 µg or 30 µg BNT162b1 induced robust antibody responses in both younger (18 to 55 years of age) and older (65 to 85) Chinese adults, and interferon-γ T-cell responses to RBD antigen challenge were significantly higher in participants receiving BNT162b1 than those in placebo groups. The 30 µg dose induced increased reactogenicity as well as a more favorable vaccine-elicited virus-neutralizing response than the 10 µg dose in both younger and older Chinese adults. In conclusion, this first report of an mRNA vaccine in an Asian population showed similar results to BNT162b1 trials.
This trial was funded by Fosun and BioNTech and registered under ChiCTR2000034825 and NCT04523571.
Figure 1
Figure 2
Figure 3