Basic Information

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

GTO ID GTC0557
Trial ID NCT04977479
Disease Allergic Reaction
Altered gene S
Therapeutic/Target gene Therapeutic gene
TherapymRNA vaccine
Treatment BNT162b2|COMIRNATY|Tozinameran;Pfizer-BioNTech COVID-19 Vaccine, Bivalent
Location approved UK, Bahrain, Israel, Canada, US, Rwanda, Serbia, United Arab Emirates, China, Mexico, Kuwait, Singapore, Saudi Arabia, Chile, Switzerland, EU, Ghana, Colombia, Philippines, Indonesia, Australia, Peru, South Korea, New Zealand, Japan, Brazil, Sri Lanka, Vietnam, South Africa, Thailand, Oman, Egypt, Malaysia;NULL
PhasePhase2
Recruitment statusCompleted
TitleA Randomized, Placebo-controlled Crossover Study to Assess the Safety of Administering a Second Dose of a COVID-19 mRNA Vaccine in Individuals Who Experienced a Systemic Allergic Reaction to an Initial Dose
Year2021
CountryUnited States
Company sponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Other ID(s)10000460|000460-I
Vector information
Vectorlipid nanoparticle

Clinical Result

Cohort1: Comirnaty
Administration route intramuscular injection
Dosage active mRNA COVID-19 vaccine, 0.3mL, one dose
Pts 16
Age Child, Adult, Older_Adult
Outcome Proportion of Participants Who Had Recurrent Systemic Allergic Reaction to Vaccine:Measure Type: Number (95% Confidence Interval):0.125(0.016 to 0.383)
Adverse reactions No serious clinical adverse events
Cohort2: Placebo
Administration route intramuscular injection
Pts 16
Age Child, Adult, Older_Adult
Adverse reactions No serious clinical adverse events
Cohort3: Comirnaty_Pfizer-BioNTech COVID-19 Vaccine, Bivalent
Administration route intramuscular injection
Dosage Comirnaty, 0.3mL, Single dose; Pfizer-BioNTech COVID-19 Vaccine, Bivalent, 0.3mL, Single dose
Pts 16
Age Child, Adult, Older_Adult
Outcome Proportion of Participants Who Had Recurrent Systemic Allergic Reaction to Vaccine:Measure Type: Number (95% Confidence Interval):0.125(0.016 to 0.383)
Adverse reactions No serious clinical adverse events

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