COVID-19: Safety and Immunogenicity of a Reduced Dose of the BioNTech/Pfizer BNT162b2 Vaccine (REDU-VAC)

Sciensano

Status and phase: Completed; Phase 4

Conditions: Covid19

Treatments: Diagnostic Test: immunogenicity after first and second dose

Study type: Interventional

Funder types: Other

Identifiers

NCT04852861

DemiVac2021

2021-002088-23 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 145 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria:

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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145 participants in 2 patient groups

Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 20 mcg

Experimental group

Description:

In this arm participants will receive two doses of Comirnaty BNT162b2 mRNA 20 mcg.

Treatment:

Diagnostic Test: immunogenicity after first and second dose

Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 30 mcg

Active Comparator group

Description:

In this arm participants will receive two doses of Comirnaty BNT162b2 mRNA 30 mcg.

Treatment:

Diagnostic Test: immunogenicity after first and second dose