Clinical trial · Interventional
Impact of the Immune System on Response to Anti-Coronavirus Disease 19 (COVID-19) Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)
Impact of the Immune System on Response to COVID-19 Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Coronavirus Disease 2019 (Covid19) | — | UNRESOLVED | — |
| Hematopoietic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Injection of anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)
- description
- Injection of two doses (at Day 1 and Day 21) of the anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)
- interventionNames
- Drug: anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)
Primary outcomes (1)
- measure
- Quantification of anti-SARS-CoV-2 receptor binding domain specific IgG
- timeFrame
- Day 49 after first injection (D0)
- description
- The primary endpoint is the quantification of different anti-SARS-CoV-2 specific IgG antibodies after vaccination (at Day 49) in allo-HCT recipients.
Secondary outcomes (5)
- measure
- Evolution of anti-SARS-CoV-2 receptor binding domain specific IgG
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * prior allogeneic hematopoietic stem cell transplantation 3 months to 5 years earlier (any donor type) * age \> or = 18 years at inclusion. * written informed consent Exclusion Criteria: * 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
References
Publications (0)
Data not yet available