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
Sponsored by
About this trial
This is an interventional diagnostic trial for Covid19 focused on measuring vaccination, Covid19, immunogenicity
Eligibility Criteria
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
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
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
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
Time Frame
180 days after first dose
Title
Humoral and cellulair immunity
Description
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
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
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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