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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: immunogenicity after first and second dose


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 20 mcg<br>In this arm participants will receive two doses of Comirnaty BNT162b2 mRNA 20 mcg. | Diagnostic Test: immunogenicity after first and second dose<br>* Humoral and cellulair immunity after first and second dose of the different vaccines administrated.<br>|
| Active Comparator: Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 30 mcg<br>In this arm participants will receive two doses of Comirnaty BNT162b2 mRNA 30 mcg. | Diagnostic Test: immunogenicity after first and second dose<br>* Humoral and cellulair immunity after first and second dose of the different vaccines administrated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMT of Neutralizing anti-bodies to Wuhan strain and variants |  | 28 days after second dose | 
| 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 | 
| 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 | 
| 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 | 
| safety and reactogenicity | adverse events will be followed up after vaccine adminstration | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccination, Covid19, immunogenicity