Basic Information

Gene symbol S Synonyms E2 Type of gene protein-coding
Gene perturbation-related omics dataset PerturbAtlas
Description spike glycoprotein

GTO ID GTC0529
Trial ID NCT04523571
Disease COVID-19
Altered gene S
Therapeutic/Target gene Therapeutic gene
TherapymRNA vaccine
Treatment BNT162b1
Location approved UK, Bahrain, Israel, Canada, US, Rwanda, Serbia, United Arab Emirates, Macao, Taiwan, Mexico, Kuwait, Singapore, Saudi Arabia, Chile, Switzerland, EU, Ghana, Colombia, Philippines, Indonesia, Australia, Hong Kong, Peru, South Korea, New Zealand, Japan, Brazil, Sri Lanka, Vietnam, South Africa, Thailand, Oman, Egypt, Malaysia
PhasePhase1
Recruitment statusCompleted
TitleSafety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects: A Phase I, Randomized, Placebo-controlled, Observer-blind Study
Year2020
CountryChina
Company sponsorBioNTech SE
Other ID(s)BNT162-03
Vector information
Vectorlipid nanoparticle

Clinical Result

Cohort1: 18-55 Years of Age_BNT162b1_dose level 1
Administration route intramuscular injection
Dosage BNT162b1, 10 µg
Pts 24
Age Adult, Older_Adult
Outcome Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo: 7|Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo: 5
Adverse reactions No serious clinical adverse events
References PMID: 35771353
Cohort2: 18-55 Years of Age_BNT162b1_dose level 2
Administration route intramuscular injection
Dosage BNT162b1, 30 µg
Pts 24
Age Adult, Older_Adult
Outcome Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo: 7|Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo: 8
Adverse reactions 0/24(All-cause mortality); 1/24(Endocrine disorders)
References PMID: 35771353
Cohort3: 18-55 Years of Age_Placebo
Administration route intramuscular injection
Pts 24
Age Adult, Older_Adult
Outcome Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo: 1|Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo: 0
Adverse reactions 0/24(All-cause mortality); 1/24(Congenital, familial and genetic disorders)
References PMID: 35771353
Cohort4: 65-85 years of age_BNT162b1_dose level 1
Administration route intramuscular injection
Dosage BNT162b1, 10 µg
Pts 24
Age Adult, Older_Adult
Outcome Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo: 2|Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo: 2
Adverse reactions 0/24(All-cause mortality); 1/24(Injury, poisoning and procedural complications)
References PMID: 35771353
Cohort5: 65-85 years of age_BNT162b1_dose level 2
Administration route intramuscular injection
Dosage BNT162b1, 30 µg
Pts 24
Age Adult, Older_Adult
Outcome Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo: 5|Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo: 7
Adverse reactions No serious clinical adverse events
References PMID: 35771353
Cohort6: 65-85 years of age_Placebo
Administration route intramuscular injection
Pts 24
Age Adult, Older_Adult
Outcome Number of Participants With Unsolicited Vaccine Related AEs During the 21-day Period After Dose 1 of BNT162b1 or Placebo: 2|Number of Participants With Unsolicited Vaccine Related AEs During the 28-day Period After Dose 2 of BNT162b1 or Placebo: 0
Adverse reactions No serious clinical adverse events
References PMID: 35771353

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