Coronavirus Disease 2019 (Covid19)Phase 3NCT04951323
Impact of the Immune System on Response to Anti-Coronavirus Disease 19 (COVID-19) Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)
A Phase 3 study testing anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer) in people with Coronavirus Disease 2019 (Covid19) and Hematopoietic Neoplasms, run by University of Liege at 1 site in Belgium.
Trial summary
The present study is a prospective phase IV study. All participants will receive the anti-Coronavirus Disease 2019 (COVID-19) Vaccine (messenger Ribonucleic acid-based vaccine, BNT162b2 or Comirnaty®, commercialized by Pfizer-BioNTech) being authorized in the European Union since December 2020. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease 2019 (Covid19), Hematopoietic Neoplasms
- What is being tested?
- anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Mar 2021to 1 Jan 2023
- Phase
- Phase 3
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- prior allogeneic hematopoietic stem cell transplantation 3 months to 5 years earlier (any donor type)
- age > or = 18 years at inclusion.
- written informed consent
Who cannot join
- HIV seropositivity
- Pregnancy
- Active malignant disease at inclusion
- Current grade III-IV acute Graft Versus Host Disease (GVHD)
- In vitro T-cell depletion of the graft if vaccination within the 6 months after transplantation.
- Rituximab administration in the 6 months prior to study inclusion
- Prior documented COVID-19 infection
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU Liège, Domaine du Sart-Tilman
Liège, 4000
Frédéric MD Baron, MD, +3243667201, F.Baron@chuliege.be
About this study
Official title: Impact of the Immune System on Response to COVID-19 Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)
The present study is a prospective phase IV study. All participants will receive the anti-Coronavirus Disease 2019 (COVID-19) Vaccine (messenger Ribonucleic acid-based vaccine, BNT162b2 or Comirnaty®, commercialized by Pfizer-BioNTech) being authorized in the European Union since December 2020. The vaccine is administered intramuscularly after dilution as a series of two doses at least 21 days apart.
Read the detailed description
The central question is whether allo-hematopoietic cell transplantation (allo-HCT) recipients can develop protective immunity against COVID-19 upon vaccination. This question needs to be answered urgently and would help the hematologist to provide recommendation / best treatment for these patients. In this pilot project Cov-Allo, this important question will be addressed in a cohort in which allo-HCT recipients will be vaccinated with the mRNA available COVID-19 vaccine according to the Belgian vaccination program. The primary objective is to assess immune response after administration of COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®; Pfizer-BioNTech) in a population of 50 patients allo-HCT recipients. This number is based on the availabilities of vaccines and eligible patients. Moreover, as the study is observational and exploratory, no sample size calculation could be provided for this study.
- Being tested
- anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)
- Medical subject headings
- COVID-19, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)Drug
Also called COVID-19 mRNA Vaccine, Pfizer
Participants will receive the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®). The vaccine is administered intramuscularly after dilution as a series of two doses at least 21 days apart.
| Study group | Role | What they receive |
|---|---|---|
| Injection of anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer) | Experimental | Injection of two doses (at Day 1 and Day 21) of the anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer) Receives: Drug: anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of anti-SARS-CoV-2 receptor binding domain specific IgG
The primary endpoint is the quantification of different anti-SARS-CoV-2 specific IgG antibodies after vaccination (at Day 49) in allo-HCT recipients.
Measured: Day 49 after first injection (D0)
Secondary outcomes (5)
Evolution of anti-SARS-CoV-2 receptor binding domain specific IgG
To study the evolution anti-RBD IgG titers from day +49 (day 28 after the second dose) to 6 months after the second dose.
Measured: 6 months after day 21
Titration of neutralizing antibodies
To analyze the titer of neutralizing antibodies at Day 49 as well as at 6 months after the second dose (at Day 21).
Measured: Day 49 and 6 months after Day 21
Clinical factors predicting response to vaccine (defined as detectable specific anti-SARS-CoV-2 RBD specific IgG).
This point aims at trying to find correlations between patient immunity at vaccination and response to vaccination and also to correlate pre-vaccination clinical factors (such as delay from transplantation to vaccination in days, presence or not of moderate/severe chronic GVHD (assessed using the NIH criteria), administration of rituximab in the year before vaccination) response to the vaccine defined as detectable specific anti-SARS-CoV-2 RBD specific IgG.
Measured: 49 days after the first dose
Efficacy of the immune response to the vaccine to prevent COVID-19
Incidence of SARS-CoV-2 infection occurring after vaccination
Measured: 12 months after first dose (Day 0)
Assessment of T cell and B cell response to the vaccine
Measuring SARS-Cov2 specific T cells (by intracellular cytokine staining) and B cells (by Elispot).
Measured: Day 7 and Day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start22 Mar 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019 (Covid19)Studies 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Frédéric Baron, University of Liege
- Investigators
- Frédéric MD Baron, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951323
- Sponsor's protocol ID
- TJB2101
- Status last verified
- May 2022
- First submitted
- 2 Jun 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Immune System on Response to COVID-19 Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)
- ClinicalTrials.gov ID
- NCT04951323
- Acronym / sponsor ID
- TJB2101
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 6 Jul 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.
The present study is a prospective phase IV study. All participants will receive the anti-Coronavirus Disease 2019 (COVID-19) Vaccine (messenger Ribonucleic acid-based vaccine, BNT162b2 or Comirnaty®, commercialized by Pfizer-BioNTech) being authorized in the European Union since December 2020. The vaccine is administered intramuscularly after dilution as a series of two doses at least 21 days apart.
Detailed description
The central question is whether allo-hematopoietic cell transplantation (allo-HCT) recipients can develop protective immunity against COVID-19 upon vaccination. This question needs to be answered urgently and would help the hematologist to provide recommendation / best treatment for these patients. In this pilot project Cov-Allo, this important question will be addressed in a cohort in which allo-HCT recipients will be vaccinated with the mRNA available COVID-19 vaccine according to the Belgian vaccination program. The primary objective is to assess immune response after administration of COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®; Pfizer-BioNTech) in a population of 50 patients allo-HCT recipients. This number is based on the availabilities of vaccines and eligible patients. Moreover, as the study is observational and exploratory, no sample size calculation could be provided for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injection of anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer) | Experimental | Drug: anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)Injection of two doses (at Day 1 and Day 21) of the anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- prior allogeneic hematopoietic stem cell transplantation 3 months to 5 years earlier (any donor type)
- age > or = 18 years at inclusion.
- written informed consent
Key exclusion criteria (7 listed)
- HIV seropositivity
- Pregnancy
- Active malignant disease at inclusion
- Current grade III-IV acute Graft Versus Host Disease (GVHD)
- In vitro T-cell depletion of the graft if vaccination within the 6 months after transplantation.
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 |
|---|---|---|
| anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)Also: COVID-19 mRNA Vaccine, PfizerParticipants will receive the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®). The vaccine is administered intramuscularly after dilution as a series of two doses at least 21 days apart. | Drug | Injection of anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer) |
Primary outcome
Quantification of anti-SARS-CoV-2 receptor binding domain specific IgG
Time frame: Day 49 after first injection (D0)
The primary endpoint is the quantification of different anti-SARS-CoV-2 specific IgG antibodies after vaccination (at Day 49) in allo-HCT recipients.
5 secondary outcomes
Evolution of anti-SARS-CoV-2 receptor binding domain specific IgG
Time frame: 6 months after day 21
Titration of neutralizing antibodies
Time frame: Day 49 and 6 months after Day 21
Clinical factors predicting response to vaccine (defined as detectable specific anti-SARS-CoV-2 RBD specific IgG).
Time frame: 49 days after the first dose
Efficacy of the immune response to the vaccine to prevent COVID-19
Time frame: 12 months after first dose (Day 0)
Assessment of T cell and B cell response to the vaccine
Time frame: Day 7 and Day 49
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
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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.
Frédéric MD Baron principal investigator
Centre Hospitalier Universitaire de Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer) in people with Coronavirus Disease 2019 (Covid19) and Hematopoietic Neoplasms, run by University of Liege 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 May 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frédéric MD Baron, Dr. MD (+3243667201, F.Baron@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of anti-SARS-CoV-2 receptor binding domain specific IgG (time frame: Day 49 after first injection (D0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2022.