COVID-19: Safety and Immunogenicity of a Reduced Dose of the BioNTech/Pfizer BNT162b2 Vaccine
NCT ID: NCT04852861
Last Updated: 2023-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
145 participants
INTERVENTIONAL
2021-05-10
2022-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
QUADRUPLE
Study Groups
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Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 20 mcg
In this arm participants will receive two doses of Comirnaty BNT162b2 mRNA 20 mcg.
immunogenicity after first and second dose
Humoral and cellulair immunity after first and second dose of the different vaccines administrated.
Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 30 mcg
In this arm participants will receive two doses of Comirnaty BNT162b2 mRNA 30 mcg.
immunogenicity after first and second dose
Humoral and cellulair immunity after first and second dose of the different vaccines administrated.
Interventions
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immunogenicity after first and second dose
Humoral and cellulair immunity after first and second dose of the different vaccines administrated.
Eligibility Criteria
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Exclusion Criteria
18 Years
55 Years
ALL
Yes
Sponsors
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Mensura EDPB
UNKNOWN
Institute of Tropical Medicine, Belgium
OTHER
Erasme University Hospital
OTHER
Sciensano
OTHER_GOV
Responsible Party
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Maria Goossens
Scientific collaborator
Locations
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Mensura EDPB
Antwerp, , Belgium
Countries
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References
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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.
Other Identifiers
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2021-002088-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DemiVac2021
Identifier Type: -
Identifier Source: org_study_id
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