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

Primary Purpose

Covid19

Status

Completed

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

immunogenicity after first and second dose

About this trial

This is an interventional diagnostic trial for Covid19 focused on measuring vaccination, Covid19, immunogenicity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Exclusion Criteria:

Sites / Locations

Mensura EDPB

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 20 mcg

Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 30 mcg

Arm Description

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

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

Outcomes

Primary Outcome Measures

Geometric Mean Titre (GMT) of Binding antibodies to the RBD of SARS-CoV-2 S protein

Binding antibodies anti-RBD

Secondary Outcome Measures

GMT of Neutralizing anti-bodies to Wuhan strain and variants

T cell response to S protein of Wuhan strain and variants and Memory B cell responses to S protein of Wuhan strain and variants

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

Humoral and cellulair immunity

safety and reactogenicity

adverse events will be followed up after vaccine adminstration

Full Information

NCT ID

NCT04852861

First Posted

April 14, 2021

Last Updated

March 27, 2023

Sponsor

Sciensano

Collaborators

Mensura EDPB, Institute of Tropical Medicine, Belgium, Erasme University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04852861

Brief Title

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

Acronym

REDU-VAC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

May 10, 2021 (Actual)

Primary Completion Date

July 31, 2021 (Actual)

Study Completion Date

September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sciensano

Collaborators

Mensura EDPB, Institute of Tropical Medicine, Belgium, Erasme University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

vaccination, Covid19, immunogenicity

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The research nurse administrating the vaccine is the only one who is not blinded.

Allocation

Randomized

Enrollment

145 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 20 mcg

Arm Type

Experimental

Arm Description

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

Arm Title

Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 30 mcg

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

immunogenicity after first and second dose

Intervention Description

Humoral and cellulair immunity after first and second dose of the different vaccines administrated.

Primary Outcome Measure Information:

Title

Geometric Mean Titre (GMT) of Binding antibodies to the RBD of SARS-CoV-2 S protein

Description

Binding antibodies anti-RBD

Time Frame

28 days after second dose

Secondary Outcome Measure Information:

Title

GMT of Neutralizing anti-bodies to Wuhan strain and variants

Time Frame

28 days after second dose

Title

T cell response to S protein of Wuhan strain and variants and Memory B cell responses to S protein of Wuhan strain and variants

Time Frame

28 days after second dose

Title

Humoral and cellulair immunity

Description

Time Frame

180 days after first dose

Title

Humoral and cellulair immunity

Description

Time Frame

365 days after first dose

Title

safety and reactogenicity

Description

adverse events will be followed up after vaccine adminstration

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Mensura EDPB

City

Antwerp

ZIP/Postal Code

2000

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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