Skip to main content
OpenTrials
Completed

NCT Number: NCT04852861

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mensura EDPB

Antwerp, 2000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Working at Mensura EDPB, not yet vaccinated for COVID19 -

Exclusion criteria

-

Treatment and study plan

immunogenicity after first and second dose

Diagnostic Test

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

Primary outcomes

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

    Time frame: 28 days after second dose

    Binding antibodies anti-RBD

Secondary outcomes

  1. GMT of Neutralizing anti-bodies to Wuhan strain and variants

    Time frame: 28 days after second dose

  2. 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

  3. Humoral and cellulair immunity

    Time frame: 180 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

  4. Humoral and cellulair immunity

    Time frame: 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

  5. safety and reactogenicity

    Time frame: through study completion, an average of 1 year

    adverse events will be followed up after vaccine adminstration

Sponsors and collaborators

Lead sponsor

Sciensano

Other Gov

Collaborators

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

Registry information

Official study title

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

Acronym: REDU-VAC

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 21, 2021
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.