NCT04852861

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P25-P50 for phase_4 covid19

Timeline
Completed

Started May 2021

Typical duration for phase_4 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

April 14, 2021

Last Update Submit

March 27, 2023

Conditions

Covid19

Keywords

vaccinationCovid19immunogenicity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

    180 days after first dose

  • Humoral and cellulair immunity

    365 days after first dose

  • safety and reactogenicity

    through study completion, an average of 1 year

Study Arms (2)

Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 20 mcg

EXPERIMENTAL

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

Diagnostic Test: immunogenicity after first and second dose

Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 30 mcg

ACTIVE COMPARATOR

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

Diagnostic Test: immunogenicity after first and second dose

Interventions

immunogenicity after first and second doseDIAGNOSTIC_TEST

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

Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 20 mcgComirnaty®; Pfizer-BioNTech BNT162b2 mRNA 30 mcg

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mensura EDPB

Antwerp, 2000, Belgium

Location

Related Publications (1)

  • Pannus P, Depickere S, Kemlin D, Houben S, Neven KY, Heyndrickx L, Michiels J, Willems E, De Craeye S, Francotte A, Chaumont F, Olislagers V, Waegemans A, Verbrugghe M, Schmickler MN, Van Gucht S, Dierick K, Marchant A, Desombere I, Arien KK, Goossens ME. Safety and immunogenicity of a reduced dose of the BNT162b2 mRNA COVID-19 vaccine (REDU-VAC): A single blind, randomized, non-inferiority trial. PLOS Glob Public Health. 2022 Dec 20;2(12):e0001308. doi: 10.1371/journal.pgph.0001308. eCollection 2022.

    PMID: 36962838DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The research nurse administrating the vaccine is the only one who is not blinded.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific collaborator

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 21, 2021

Study Start

May 10, 2021

Primary Completion

July 31, 2021

Study Completion

September 30, 2022

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations

BE(1)