Covid19
Conditions
Keywords
vaccination, Covid19, immunogenicity
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.
Interventions
DIAGNOSTIC_TESTimmunogenicity after first and second dose
Humoral and cellulair immunity after first and second dose of the different vaccines administrated.
Sponsors
Mensura EDPB
Institute of Tropical Medicine, Belgium
Erasme University Hospital
Sciensano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The research nurse administrating the vaccine is the only one who is not blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Working at Mensura EDPB, not yet vaccinated for COVID19 -
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Countries
Belgium
Outcome results
None listed