Infections

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

COVID-19

All Drugs and Chemicals

Vaccines

administer an additional dose of the BNT162b2 mRNA vaccine to patients with cancer who have a negative SARS-CoV-2 Spike IgG at least 14 days after 2 doses of the mRNA vaccines (BNT162b2/mRNA-1273) or 28 days after the adenoviral based Ad26CoV2.S vaccine.

BNT162b2 vaccine

Balazs Halmos

The goal of this study is to assess the safety and effectiveness of a COVID vaccine booster in patients with cancer who have not developed an antibody after the U.S. Food and Drug Administration (FDA) Emergency Use Authorized COVID vaccination series

Booster Dose Trial

Safety and Efficacy of Booster Doses of BNT162b2 Vaccine in Immunocompromised Patients With a Cancer Diagnosis

Albert Einstein College of Medicine

Montefiore Medical Center

Nervous System Diseases

Immune System Diseases

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Multiple Sclerosis

Sclerosis

Diabetes Mellitus, Type 2

Multiple Myeloma

Neoplasms, Plasma Cell

Diabetes Mellitus

Hematologic Neoplasms

Acquired Immunodeficiency Syndrome

HIV Infections

Hypergammaglobulinemia

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Hematologic Diseases

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Blood Protein Disorders

Immunoproliferative Disorders

Antibodies

Immunoglobulins

Antibodies, Anti-Idiotypic

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 samples

Aymeric SEVE, Dr

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.

The serious, even fatal, forms of COVID-19 preferentially affect elderly and fragile subjects. Among these populations at risk, people who are immunocompromised (either by a disease and / or its treatment) have a theoretical risk of responding less well to a preventive vaccination.

The main objective of this study aims to compare the vaccine response of immunocompromised people with healthy subjects (non-immunocompromised), i.e. to assess the serum humoral response (titre and neutralizing capacity of the antibodies induced) following vaccination with ComirnatyTM (i.e. BNT162b2, an anti-SARS-CoV-2 vaccine from Pfizer BioNTech) in immunocompromised persons in comparison to healthy subjects (non-immunocompromised).

Secondary objectives are as follows:

* To evaluate the antibody response in the nasal mucosa (titre and neutralizing capacity of the antibodies induced, collected by means of a nasopharyngeal swab) following vaccination with ComirnatyTM in immunocompromised people as compared to healthy subjects (vaccinated either with two doses of ComirnatyTM or, in a subgroup, with one dose of Astra Zeneca's VaxzeriaTM followed by one dose of ComirnatyTM).
* Evaluate the serum and mucosal antibody response (titre and neutralizing capacity of the antibodies induced) against emerging strains of SARS-CoV-2 (so-called Alpha, Beta, Gamma, Delta strains).
* Evaluate the post-vaccination clinical protection against the risk of COVID-19 infection (incident cases after vaccination).

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

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

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

Proportion of immunocompromised people with neutralizing activity in the nasal mucosa against the classic "Wuhan" strain of SARS-CoV-2 one month after the second dose of the vaccine, compared to the proportion obtained in healthy subjects.

Proportion of immunocompromised people with neutralizing activity in the serum and nasal mucosa against emerging strains of SARS-CoV-2 (so-called Alpha, Beta, Gamma, Delta strains)

Proportion of participants developing COVID-19 infection after vaccination

Centre Hospitalier Régional d'Orléans

Chronic Disease

Pneumonia

Pneumonia, Viral

Communicable Diseases

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Disease Attributes

Chronic Graft Versus Host Disease

Antineoplastic Agents

Androgens

Immune Checkpoint Inhibitors

Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.

People with hematological malignancies or solid tumors in various phases of their treatment (under treatment or in remission/ follow-up). This cohort may include patients with smoldering multiple myeloma (n=50), multiple myeloma (n=140), chronic lymphocytic leukemia (with or without hypoglobulinemia) (n=50), lymphoma (n=80), AL amyloidosis (n=30), patients who receive PARP (n=30), CDK4/6 (n=30), or immune checkpoint inhibitors (n=40), and patients under therapy with Androgen Receptor Targeted Agents (n=50).

Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies

BNT162b2

Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2

Other vaccine against SARS-Cov-2

Ioanna Charitaki

Evangelos Terpos, MD

Evangelos Terpos

Determination of both the degree and duration of the immunity provided after receiving the BNT162b2 vaccine against SARS-Cov-2.

The purpose of this study is to assess the kinetics of antibodies against SARS-CoV-2 as well as the kinetics of the immune system's cell subpopulations and cytokines associated with the immune system in healthy volunteers receiving the BNT162b2 vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies or any other vaccine authorized and administered by the Ministry of Health. Immunoassays will be performed at serum collection points before and after vaccination, as set out in this study.

Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System

Study of the Kinetics of Antibodies Against SARS-CoV-2 and of Cellular Subpopulations of the Immune System in Volunteers Receiving the BNT162b2 Vaccine or Other Approved Vaccine Against SARS-CoV-2

At the end of the study, the results will be announced in medical conferences or medical journals.

Primary endpoint of the study is the development of neutralizing antibodies against SARS-CoV-2 on Day 50 28 days after the second dose of the vaccine) in the study populations

Development of neutralizing antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)

Development of neutralizing antibodies against SARS-CoV-2 on day 8

Development of neutralizing antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)

Development of neutralizing antibodies against SARS-CoV-2 on day 36

Development of neutralizing antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine

Development of neutralizing antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine

Development of neutralizing antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine

Development of neutralizing antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine

Development of neutralizing antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine

Development of anti-S-RBD antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)

Development of anti-S-RBD antibodies against SARS-CoV-2 on day 8

Development of anti-S-RBD antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)

Development of anti-S-RBD antibodies against SARS-CoV-2 on day 36

Development of anti-S-RBD antibodies against SARS-CoV-2 on day 50

Development of anti-S-RBD antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine

Development of anti-S-RBD antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine

Development of anti-S-RBD antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine

Development of anti-S-RBD antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine

Development of anti-S-RBD antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine

According to antibody responses on day 22 (before the second dose of the vaccine)

According to antibody responses on day 36

According to antibody responses on day 50

According to antibody responses at 3 months post the second dose of the vaccine

According to antibody responses at 6 months post the second dose of the vaccine

According to antibody responses at 9 months post the second dose of the vaccine

According to antibody responses at 12 months post the second dose of the vaccine

According to antibody responses at 18 months post the second dose of the vaccine

Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)

Inflammatory cytokines measurements on day 8

Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)

Inflammatory cytokines measurements on day 23

Inflammatory cytokines measurements on day 36

Inflammatory cytokines measurements on day 50

Inflammatory cytokines measurements at 3 months post the second dose of the vaccine

Inflammatory cytokines measurements at 6 months post the second dose of the vaccine

Inflammatory cytokines measurements at 9 months post the second dose of the vaccine

Inflammatory cytokines measurements at 12 months post the second dose of the vaccine

Inflammatory cytokines measurements at 18 months post the second dose of the vaccine

CRP blood level measurements on day 1 (before the first dose of the vaccine)

CRP blood level measurements on day 22 (before the second dose of the vaccine)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Booster Dose Trial	NCT05016622	Cancer	BNT162b2 vaccin...	18 Years -	Montefiore Medical Center
Study Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy Adults	NCT04952766	Kidney Transpla... Myeloma Cancer Hematologic Mal... Multiple Sclero... Hypergammaglobu... Malignant Tumor Hiv Diabetes Type 2	Biological samp...	18 Years -	Centre Hospitalier Régional d'Orléans
Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System	NCT04743388	COVID-19 Healthy Volunte... Chronic Disease Hematological M... Solid Tumor	BNT162b2 Other vaccine a...	18 Years -	National and Kapodistrian University of Athens
Booster Dose Trial	NCT05016622	Cancer	BNT162b2 vaccin...	18 Years -	Montefiore Medical Center

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