Study Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy Adults

NCT04952766 | Completed Phase 4

• 1 other identifier: CHRO-2021-04
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

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

Multiple Sclerosis; Hypergammaglobulinemia; Malignant Tumor; Hiv; Diabetes Type 2; Kidney Transplant; Myeloma; Cancer; Hematologic Malignancy

Keywords

SARS-CoV-2; BNT162b2 vaccine; antibody; neutralization; mucosa; immunocompromised; healthy subject

Outcome Measures

Primary Outcomes (1)

• Protective humoral response after vaccination

  Proportion of immunocompromised persons with neutralizing activity against the classic "Wuhan" strain of SARS-CoV-2 compared to the proportion obtained in healthy subjects.

  Month 2

Secondary Outcomes (15)

• Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)

  Month 0

• Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)

  Month 1

• Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)

  Month 2

• Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)

  Month 3

• Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)

  Month 6

Study Arms (1)

immunocompromised and healthy subjects

OTHER

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)

Biological: Biological samples

Interventions

Biological samples BIOLOGICAL

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)

immunocompromised and healthy subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• people vaccinated with the ComirnatyTM

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHU Orléans

Orléans, 45067, France

Location

Related Publications (2)

• Grzelak 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 BACKGROUND

• Planas 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 BACKGROUND

MeSH Terms

Conditions

Neoplasms, Plasma Cell; Neoplasms; Hematologic Neoplasms; Multiple Sclerosis; Hypergammaglobulinemia; Acquired Immunodeficiency Syndrome; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Blood Protein Disorders; Immunoproliferative Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Aymeric SEVE, Dr

  CHU Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants wil have at each of the 4 visits (for patients starting at month 1) or 5 visits (for patients starting at month 0): 1. a venipuncture sample of 2 dry tubes of 7 mL (less than 30 mL in total) to make up 3 aliquots and 2. a nasopharyngeal swab (optional). The aliquots of serum / plasma and the nasopharyngeal swab will be stored at -80°C until sent to the Pasteur Institute.

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 7, 2021
• Study Start: March 26, 2021
• Primary Completion: February 6, 2022
• Study Completion: February 6, 2022
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)