Clinical trial NCT04852861: COVID-19: Safety and Immunogenicity of a Reduced Dose of the BioNTech/Pfizer BNT162b2 Vaccine
Official title: COVID-19: Safety and Immunogenicity of a Reduced Dose of the BioNTech/Pfizer BNT162b2 Vaccine in a Healthy Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Covid19
Keywords: vaccination
Covid19
immunogenicity
Lead sponsor: Sciensano
Sponsor class: OTHER_GOV
Collaborators: name: Mensura EDPB
name: Institute of Tropical Medicine, Belgium
name: Erasme University Hospital
First posted: 2021-04-21
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a randomized phase IV dose-optimization study evaluating the safety and immunogenicity of two doses of COVID-19 mRNA vaccines being authorized in the European Union since December 2020: Vaccine BNT162b2 (Comirnaty®; Pfizer-BioNTech) in healthy adults up to age 55 year. Immunogenicity will be measured 28 days after first and second dose, and day 180 and day 365 after first vaccination of 20 and 30 mcg of BNT162b2. The primary outcome is the level of binding antibodies for RBD 28 days after the second dose.

Detailed description: Background: Data from the dose-escalating phase 1 trials from the COVID-19 mRNA vaccines being authorized in the European Union since December 2020, BNT162b2 (Comirnaty®; Pfizer- BioNTech) indicate that for the age group 18-55 years a lower dose of the vaccine can induce the same immune response as the full dose.

Method: This is a randomized multicenter phase IV dose-optimization study evaluating the safety and immunogenicity of demi-doses of a COVID-19 mRNA vaccine being authorized in the European Union since December 2020, BNT162b2 (Comirnaty®; Pfizer- BioNTech) in healthy adults up to age 55 year. The study will be performed in employees of Mensura EDPB at five different sites.

Objectives: The primary outcome is the level of binding antibodies for RBD 28 days after the second dose. Secondary outcomes are safety and reactogenicity after vaccination. The neutralizing antibodies and the cellular immunity 28 days after second dose will be assessed. Humoral and cellular immunity will be measured 180 and 365 days after first dose.

Eligibility criteria: Inclusion Criteria: Working at Mensura EDPB, not yet vaccinated for COVID19 -

Exclusion Criteria:

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Primary outcomes:
measure: Geometric Mean Titre (GMT) of Binding antibodies to the RBD of SARS-CoV-2 S protein
timeFrame: 28 days after second dose
Secondary outcomes:
measure: GMT of Neutralizing anti-bodies to Wuhan strain and variants
timeFrame: 28 days after second dose
measure: T cell response to S protein of Wuhan strain and variants and Memory B cell responses to S protein of Wuhan strain and variants
timeFrame: 28 days after second dose
measure: Humoral and cellulair immunity
timeFrame: 180 days after first dose
measure: Humoral and cellulair immunity
timeFrame: 365 days after first dose
measure: safety and reactogenicity
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Mensura EDPB
Study officials:
References: