Covid19Phase 4REDU-VACNCT04852861
COVID-19: Safety and Immunogenicity of a Reduced Dose of the BioNTech/Pfizer BNT162b2 Vaccine
A Phase 4 study testing immunogenicity after first and second dose in people with Covid19, run by Sciensano at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- immunogenicity after first and second dose
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteBelgium
- Study dates
- 10 May 2021to 30 Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19: Safety and Immunogenicity of a Reduced Dose of the BioNTech/Pfizer BNT162b2 Vaccine in a Healthy Population
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- immunogenicity after first and second dose
- Keywords
- vaccination, Covid19, immunogenicity
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunogenicity after first and second doseDiagnostic test
Humoral and cellulair immunity after first and second dose of the different vaccines administrated.
| Study group | Role | What they receive |
|---|---|---|
| Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 20 mcg | Experimental | In this arm participants will receive two doses of Comirnaty BNT162b2 mRNA 20 mcg. Receives: 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. Receives: Diagnostic Test: immunogenicity after first and second dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titre (GMT) of Binding antibodies to the RBD of SARS-CoV-2 S protein
Binding antibodies anti-RBD
Measured: 28 days after second dose
Secondary outcomes (5)
GMT of Neutralizing anti-bodies to Wuhan strain and variants
Measured: 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
Measured: 28 days after second dose
Humoral and cellulair immunity
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
Measured: 180 days after first dose
Humoral and cellulair immunity
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
Measured: 365 days after first dose
safety and reactogenicity
adverse events will be followed up after vaccine adminstration
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start10 May 2021
- Primary completion31 Jul 2021
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciensano
- Sponsor type
- Other government
- Collaborators
- Mensura EDPB, Institute of Tropical Medicine, Belgium, Erasme University Hospital
- Responsible party
- Principal investigator, Maria Goossens, Sciensano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852861
- Sponsor's protocol ID
- DemiVac2021
- Other IDs
- 2021-002088-23
- Acronym
- REDU-VAC
- Status last verified
- Mar 2023
- First submitted
- 14 Apr 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Depickere S, Pannus P, Houben S, Charles A, Heyndrickx L, Georges D, Verbrugghe M, Marchant A, Desombere I, Arien KK, Goossens ME. Safety and immunogenicity of a reduced, homologous booster dose of the BNT162b2 mRNA COVID-19 vaccine: a single blind, randomized, non-inferiority follow-up trial. Vaccine. 2026 Jul 3;89:128897. doi: 10.1016/j.vaccine.2026.128897. Online ahead of print.
PubMed 42398210Pannus 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.
PubMed 36962838
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19: Safety and Immunogenicity of a Reduced Dose of the BioNTech/Pfizer BNT162b2 Vaccine in a Healthy Population
- ClinicalTrials.gov ID
- NCT04852861
- Acronym / sponsor ID
- REDU-VAC / DemiVac2021
- Conditions
- Covid19
- Keywords
- vaccination, Covid19, immunogenicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- SciensanoOther government
- Collaborators
- Mensura EDPB, Institute of Tropical Medicine, Belgium, Erasme University Hospital
- Study start
- 10 May 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 20 mcg | Experimental | Diagnostic Test: immunogenicity after first and second doseIn this arm participants will receive two doses of Comirnaty BNT162b2 mRNA 20 mcg. |
| Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 30 mcg | Active comparator | Diagnostic Test: immunogenicity after first and second doseIn this arm participants will receive two doses of Comirnaty BNT162b2 mRNA 30 mcg. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunogenicity after first and second doseHumoral and cellulair immunity after first and second dose of the different vaccines administrated. | Diagnostic test | Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 20 mcg, Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 30 mcg |
Primary outcome
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
5 secondary outcomes
GMT of Neutralizing anti-bodies to Wuhan strain and variants
Time frame: 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
Time frame: 28 days after second dose
Humoral and cellulair immunity
Time frame: 180 days after first dose
Humoral and cellulair immunity
Time frame: 365 days after first dose
safety and reactogenicity
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Derived from this study: PubMed 42398210Depickere S, Pannus P, Houben S, Charles A, Heyndrickx L, Georges D, Verbrugghe M, Marchant A, Desombere I, Arien KK, Goossens ME. Safety and immunogenicity of a reduced, homologous booster dose of the BNT162b2 mRNA COVID-19 vaccine: a single blind, randomized, non-inferiority follow-up trial. Vaccine. 2026 Jul 3;89:128897. doi: 10.1016/j.vaccine.2026.128897. Online ahead of print.
- Derived from this study: PubMed 36962838Pannus 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing immunogenicity after first and second dose in people with Covid19, run by Sciensano at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Titre (GMT) of Binding antibodies to the RBD of SARS-CoV-2 S protein (time frame: 28 days after second dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04852861, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.