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

Phase 4

Completed

• Conditions: Covid19
• Interventions: Diagnostic Test: immunogenicity after first and second dose

• Registration Number: NCT04852861
• Lead Sponsor: Sciensano

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.

Study Timeline

• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-21
• Study Start: 2021-05-10
• Primary Completion: 2021-07-31
• Study Completion: 2022-09-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

Working at Mensura EDPB, not yet vaccinated for COVID19 -

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 20 mcg	immunogenicity after first and second dose	In this arm participants will receive two doses of Comirnaty BNT162b2 mRNA 20 mcg.
Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 30 mcg	immunogenicity after first and second dose	In this arm participants will receive two doses of Comirnaty BNT162b2 mRNA 30 mcg.

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titre (GMT) of Binding antibodies to the RBD of SARS-CoV-2 S protein	28 days after second dose	Binding antibodies anti-RBD

Secondary Outcome Measures

Name	Time	Method
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	365 days after first dose	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	through study completion, an average of 1 year	adverse events will be followed up after vaccine adminstration

Trial Locations

Locations (1)

Mensura EDPB; 🇧🇪 Antwerp, Belgium