Clinical trial · Interventional
Study Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy Adults
NCT04952766CI-TRIAL-00099566EREVAcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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 primary endpoint of this study is to compare the humoral response (titre and neutralizing capacity of induced antibodies) against SARS-CoV-2 following vaccination with BNT162b2 (Pfizer BioNTech) in immunocompromised persons, in comparison to healthy subject. Secondary objectives are to evaluate the humoral response in the nasal mucosa, and the capacity of antibodies to neutralize emerging variants of concerns and to prevent COVID-19.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Diabetes Type 2 | — | UNRESOLVED | — |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hiv | — | UNRESOLVED | — |
| Hypergammaglobulinemia | — | UNRESOLVED | — |
| Kidney Transplant | — | UNRESOLVED | — |
| Malignant Tumor | Malignant Neoplasm | ALIAS | 0.90 |
| Multiple Sclerosis | — | UNRESOLVED | — |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biological samples | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- immunocompromised and healthy subjects
- description
- Immunocompromised subjects and healthy subjects groups will have collection of biological samples (blood with/without nasopharyngeal swabs) at Month-0, -1, -2, -3, -6, with associated data for the study of the kinetics of antibodies anti COVID-19. Biological samples : * Serum and plasma from each participant for the purpose of performing the SARS-CoV-2 serologic tests * Nasopharyngeal samples (not mandatory) Associated data : * Demographic data * Description of clinical manifestations related to vaccination * Description of clinical manifestations related to SARS-CoV-2 infection, if any Blood Fractioning * Serum and plasma aliquoted and stored under 250, 500 and 1000 µL (at -80°C)
- interventionNames
- Biological: Biological samples
Primary outcomes (1)
- measure
- Protective humoral response after vaccination
- timeFrame
- Month 2
- description
- Proportion of immunocompromised persons with neutralizing activity against the classic "Wuhan" strain of SARS-CoV-2 compared to the proportion obtained in healthy subjects.
Secondary outcomes (15)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Adult volunteers to be vaccinated with the ComirnatyTM vaccine and to participate in the study, belonging to one of the following groups:
* Group of immunocompromised (15 participants per immunosuppression subgroup):
* Kidney transplant
* Extracorporeal dialysis
* Solid cancer under chemotherapy and / or radiotherapy
* Myeloma under chemotherapy
* Hematologic malignancies under chemotherapy
* Diseases treated with anti CD20 (or patients not treated at the time of the vaccine but who will be immediately after)
* Multiple sclerosis under anti CD20 (or patients not treated at the time of the vaccine but who will be immediately after)
* Common variable immune deficiency or other causes of severe hypogammaglobulinemia requiring chronic treatment with polyvalent immunoglobulin
* Malignant tumor under anti-PD1 or anti-PDL1
* People living with HIV
* Complicated type 2 diabetes (with micro and / or macroangiopathy)
* Group of non-immunocompromised subjects (controls, n = 75)
* 60 people vaccinated with the ComirnatyTM
* 15 people vaccinated with Astra Zeneca's VaxzevriaTM for the first dose
Exclusion Criteria:
* Minors
* Pregnant or breastfeeding women
* Persons under tutorship or curatorship
* Protected adults
* Person under legal protection
* Person not affiliated to a social security scheme
* People with a contraindication to receiving the ComirnatyTM vaccine
* People who have already been vaccinated against SARS-CoV-2
Note: a history of COVID-19 (\> at 3 months) is not a contraindication to vaccination and is therefore not a criterion for non-inclusion in the study.References
Publications (2)
- BACKGROUNDGrzelak L, Temmam S, Planchais C, Demeret C, Tondeur L, Huon C, Guivel-Benhassine F, Staropoli I, Chazal M, Dufloo J, Planas D, Buchrieser J, Rajah MM, Robinot R, Porrot F, Albert M, Chen KY, Crescenzo-Chaigne B, Donati F, Anna F, Souque P, Gransagne M, Bellalou J, Nowakowski M, Backovic M, Bouadma L, Le Fevre L, Le Hingrat Q, Descamps D, Pourbaix A, Laouenan C, Ghosn J, Yazdanpanah Y, Besombes C, Jolly N, Pellerin-Fernandes S, Cheny O, Ungeheuer MN, Mellon G, Morel P, Rolland S, Rey FA, Behillil S, Enouf V, Lemaitre A, Creach MA, Petres S, Escriou N, Charneau P, Fontanet A, Hoen B, Bruel T, Eloit M, Mouquet H, Schwartz O, van der Werf S. A comparison of four serological assays for detecting anti-SARS-CoV-2 antibodies in human serum samples from different populations. Sci Transl Med. 2020 Sep 2;12(559):eabc3103. doi: 10.1126/scitranslmed.abc3103. Epub 2020 Aug 17. PMID 32817357
- BACKGROUNDPlanas D, Bruel T, Grzelak L, Guivel-Benhassine F, Staropoli I, Porrot F, Planchais C, Buchrieser J, Rajah MM, Bishop E, Albert M, Donati F, Prot M, Behillil S, Enouf V, Maquart M, Smati-Lafarge M, Varon E, Schortgen F, Yahyaoui L, Gonzalez M, De Seze J, Pere H, Veyer D, Seve A, Simon-Loriere E, Fafi-Kremer S, Stefic K, Mouquet H, Hocqueloux L, van der Werf S, Prazuck T, Schwartz O. Sensitivity of infectious SARS-CoV-2 B.1.1.7 and B.1.351 variants to neutralizing antibodies. Nat Med. 2021 May;27(5):917-924. doi: 10.1038/s41591-021-01318-5. Epub 2021 Mar 26. PMID 33772244