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

Covid19 Clinical Trial

— REDU-VAC  

Official title:

COVID-19: Safety and Immunogenicity of a Reduced Dose of the BioNTech/Pfizer BNT162b2 Vaccine in a Healthy Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04852861
• Other study ID #: DemiVac2021
• Secondary ID: 2021-002088-23
• Status: Completed
• Phase: Phase 4
• Start date: May 10, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2023
• Source: Sciensano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: September 30, 2022
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• immunogenicity after first and second dose
Humoral and cellulair immunity after first and second dose of the different vaccines administrated.

Locations

Country	Name	City	State
Belgium	Mensura EDPB	Antwerp

Sponsors (4)

Lead Sponsor	Collaborator
Sciensano	Erasme University Hospital, Institute of Tropical Medicine, Belgium, Mensura EDPB

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titre (GMT) of Binding antibodies to the RBD of SARS-CoV-2 S protein	Binding antibodies anti-RBD	28 days after second dose
Secondary	GMT of Neutralizing anti-bodies to Wuhan strain and variants		28 days after second dose
Secondary	T cell response to S protein of Wuhan strain and variants and Memory B cell responses to S protein of Wuhan strain and variants		28 days after second dose
Secondary	Humoral and cellulair immunity	GMT of of Binding antibodies to the RBD of SARS-CoV-2 S protein and Neutralizing anti-bodies to Wuhan strain and variants and T cell response to S protein of Wuhan strain and variants and Memory B cell responses to S protein of Wuhan strain and variants	180 days after first dose
Secondary	Humoral and cellulair immunity	GMT of of Binding antibodies to the RBD of SARS-CoV-2 S protein and Neutralizing anti-bodies to Wuhan strain and variants and T cell response to S protein of Wuhan strain and variants and Memory B cell responses to S protein of Wuhan strain and variants	365 days after first dose
Secondary	safety and reactogenicity	adverse events will be followed up after vaccine adminstration	through study completion, an average of 1 year