Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

All Conditions

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Peripheral blood mononuclear cells (PBMC) will be collected from healthy volunteers and patients who present with different diseases that involve or implicate the immune system dysregulation (HIV infection, autoimmune diseases and cancer). These PBMC will be studied in vitro for a number of functional parameters, including generating soluable factors that inhibit HIV infection, developing patterns of immune dysregulation, and inducing apoptotic T cell death. The purpose of such studies is to obtain insight into the mechanisms of natural resistance to viral infections, AIDS pathogenesis, and disease-induced immune dysregulation.

In Vitro Study of Peripheral Blood Mononuclear Cell Function in Healthy Individuals and Patients

National Cancer Institute (NCI)

Symptoms and General Pathology

Syndrome

The goal of the protocol is to define the normal humoral and cellular immune responses to antigens in volunteers and to define abnormalities of these immune responses in patients with immunodeficiency diseases or cancer. In vitro assays and in vivo skin tests and immunization with antigens will be utilized.

Studies of the Immune Response in Normal Subjects and Patients With Disorders of the Immune System

Nervous System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Multiple Sclerosis

Sclerosis

COVID-19

Pneumonia

Pneumonia, Viral

Communicable Diseases

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

All Drugs and Chemicals

Antibodies

Vaccines

Immunoglobulins

Antibodies, Blocking

Blood samples at:

* D0 (the day of the injection of the SARS-CoV-2 vaccine),
* during the 2nd injection as part of the national vaccination campaign (on D28)
* during the 3rd injection for patients for whom a third injection is recommended (according to the recommendations in force)
* then to M1, M6 and M12 of the last injection

Blood samples for the study of the humoral response to SARS-CoV-2 variants and of the cellular response after vaccination against COVID-19

Prospective, multicenter, non-comparative cohort study of immunocompromised people vaccinated against Covid-19 with the aim to know the humoral and cellular response to BNT162b2 vaccination against SARS-CoV-2 variants. This study will enroll patients in 5 parallel sub-cohorts of the same size, distinct according to the source of the immunosuppression: autoimmune or auto-inflammatory disease, HIV infection, multiple sclerosis, solid cancer, organ transplantation with prospective data collection and constitution of biological collections.

The SARS-CoV-2 pandemic represents an extraordinary challenge for global health, it has caused more than 97 million cases of Covid-19 and 2 million deaths worldwide as of January 22, 2021. Vaccination against Covid-19 is an essential weapon to mitigate the consequences of the SARS-CoV-2 pandemic. Its effect in reducing mortality is of course expected in people most vulnerable to Covid-19 such as immunocompromised people.

In general, the immunogenicity of vaccines in immunocompromised populations is conditioned by the nature and intensity of the chronic pathology (s), the age and the treatments received. In addition, the emergence of new variants of SARS-CoV-2 is a major concern today. Three new variants that have rapidly become dominant within their countries have aroused concerns: B.1.1.7 (also known as VOC-202012/01), 501Y.V2 (B.1.351), and P.1 (B.1.1.28.1) and questions are raised about their potential to escape from vaccine-induced immunity. It is therefore important to be able to assess vaccine efficacy in subjects who are fragile with respect to these variants.

The investigators are proposing the establishment of a multicenter cohort study of immunocompromised people vaccinated against Covid-19 with the aim to know the humoral and cellular response to BNT162b2 vaccination against SARS-CoV-2 variants. The primary objective is to evaluate the neutralizing capacity of the antibodies regarding different variants of SARS-CoV-2 after vaccination on 1 month after the first injection, then on 1, 6 and 12 months after the last injection. In-depth immunophenotyping of immune blood cells which analyzes in detail the subpopulations of T lymphocytes and their responses to SARS-CoV-2 will be also analyze before vaccination and after vaccination on 1 month after the first injection, then on 1 month after the last injection. Extensive explorations of the humoral and cellular response to BNT162b2 vaccination will provide crucial data on the potential efficacy of the BNT162b2 vaccine on the recently identified SARS-CoV-2 variants, as well as innovative data on the dynamic of the functional responses of T cells and of the TCR repertoire, the dynamic of which (increase after vaccination, remote contraction) makes it possible to link them to a vaccine response, as has already been done in the context of other vaccination.

This study will provide a better understanding of the biological response to BNT162b2 vaccination in immunocompromised people with respect to the English VOC 202012/01, South African 501Y.V2 variants and any other variants that may emerge. In particular, the investigators are waiting to be able to estimate the proportion of patients whose immunogenicity suggests a reduction in the frequency of severe forms of COVID-19. Conversely, the investigators are waiting to estimate the proportion of patients with a level of immunogenicity too low to hope for good clinical protection against COVID-19. In addition, there are no data on the durability of the biological response to BNT162b2 vaccination.

It is possible that these observations could lead to the implementation of reinforced vaccination protocols for this population, as is already the case for vaccination for hepatitis B vaccination.

Study of the Humoral Response to SARS-CoV-2 Variants and of the Cellular Response After Vaccination Against COVID-19 in Immunocompromised People

Count of CD4 / CD8, B and NK T lymphocyte populations and quantification of Treg lymphocytes on fresh cells. In-depth immunophenotyping of T lymphocytes with naive distributions / memories and activation markers and on naive B distributions / memories and other classically described subpopulations

High throughput TCR sequencing (Barennes et al, Nat Biotech, 2021) will be performed on separated CD8 and CD4 T cells. Standard diversity metrics, such as V and J gene usage, VJ combination and clonotype frequencies will describe the global repertoire structures before and after vaccination. TCR signatures that could characterize the immune response to vaccination will be define based on the dynamics of sequences. For such studies, analyses are based exclusively on the CDR3 region of the TCRs such as to analyze humans independently of their HLA genotype. Finally, we will search for virus specific TCRs using our curated database (Barennes et al, Nat Biotech, 2021)

Assistance Publique - Hôpitaux de Paris

Herbal and Botanical

Cola

Woo Yong Lee, MD,PhD

This study aimed to clarify existence of immunological benefit of laparoscopic colon cancer surgery compared to open colon surgery.

Patients with clinical stage Ⅲ left colon and upper rectal cancer were prospectively assigned to undergo LC (n=35) or OC (n=39). Factors related to cellular immunity of host (total lymphocyte count, CD4 lymphocyte, CD8 lymphocyte, CD4/CD8 ratio, HLA-DR expression on monocyte (mHLA-DR)) were examined preoperatively, on the 1st day of operation (POD1) and the 5th day of operation (POD5).

Prospective Comparison of Immunological Benefit of Laparoscopic Colectomy

Prospective Comparative Study of Immunological Benefit Between Laparoscopic Colectomy and Open Colectomy

Samsung Medical Center

Woo Yong Lee/Associate Professor, Department of Surgery, Samsung Medical Center

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Leukemia

Lymphoma

Lymphosarcoma

Peripheral blood mononuclear cells (PBMC) will be collected from patients who have leukemia or lymphoma or other medical conditions involving altered lymphohematopoietic stem cell or immunological function. These PBMC will be assessed for cellular markers by flow cytometry and will be studied for in vitro T helper, effector and suppressor cell functions, to determine whether cell mediated immunity is involved in the condition, or indicative of therapeutic efficacy or is predictive for outcome. Peripheral blood stem cells (PBSC) from untreated donors and from cytokine treated donors will be assessed for cellular markers and in vitro growth characteristics that might be useful for identifying normal stem cell populations.

Peripheral blood mononuclear cells (PBMC) and mobilized peripheral blood stem cells (PBSC) will be collected from patients who have leukemia or lymphoma or other medical conditions involving altered lymphohematopoietic stem cell or immunological function. These PBMC will be assessed for cellular markers by flow cytometry and will be studied for in vitro T helper, effector and suppressor cell functions, to determine whether cell mediated immunity is involved in the condition, or indicative of therapeutic efficacy or is predictive for outcome. PBSC will be assessed for cellular markers and in vitro growth characteristics that might be useful for identifying normal stem cell populations. Furthermore the capacity of stem cells to reconstitute the T lymphocyte lineage will be assessed using ex vivo explant cultures established with thymic or secondary lymphoid tissues.

In Vitro Studies of Immunological and Stem Cell Function in Peripheral Blood Mononuclear Cells in Patients

Carcinoma, Renal Cell

Kidney Neoplasms

Carcinoma

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

RCC patients (30 pts) will include patients with kidney cancer (renal cell cancer).

Investigators will collect and analyze:

* blood sample,
* urine sample,
* kidney tissue sample (healthy tissue, carcinomatous tissue and borderline tissue between them).

In this group (30 patients) will be recruiting healthy patients (volunteer).

Investigators will collect and analyze:

* blood sample.

Dean Markić, MD, PhD

Renal cell cancer (RCC) is one of the most important urogenital tumors because of it's high mortality and increasing incidence. RCC, which accounts about 3% of all malignant tumors in the adults, is the most lethal urogenital cancer. The high mortality rate stimulate investigator groups to study RCC pathogenesis including immunological part. It is interesting that immunotherapy was firstly started in patients with metastatic RCC using IL-2 and interferon gamma. The first results were promising but the exact mechanism of acting was not found. In the RCC, as in the others tumors, immune cells (T lymphocytes, NK and NKT cells) are responsible for main antitumor effect. Their effect was caused by cytotoxic activity on the tumor cells. In the investigation investigators will determine patterns of aggregation of tumor infiltrating immune cells in the blood, healthy kidney and carcinomatous tissue. But, presence of this cells not implicated that this cells are active. Their activity will be determined by proofing cytotoxicity of different subgroup of immune cells. In that way investigators will present different patterns of aggregation of tumor infiltrating immune cells and their cytotoxicity which will direct that this cells are active with antitumor effect. Correlation of collected data with classical prognostic factors in the patients with RCC as tumor staging, tumor grading (Fuhrman) and histological subtype will help to determine some immunological factors as possible new prognostic factors. For conclusion, the results of this study will allow better understanding of RCC pathogenesis, specially their immunological part and become a foundation for the future investigations.

Cellular immunity will be investigated in the two group of patients: operated patients with RCC and healthy volunteers.

In the study investigators will determine patterns of aggregation of tumor infiltrating immune cells in the blood (RCC patients and volunteers), healthy kidney and carcinomatous tissue as their cytotoxicity (only RCC patients).

Investigators will determine:

1. presence of different immune cells in the blood and kidney tissue (T lymphocytes, NK cells, NKT cells, T regulatory cells),
2. presence and distribution of cytolytic molecule perforin and granulysin in immune cells (T lymphocytes, NK cells, NKT cells) in the blood, kidney tissue and urine
3. NK cytotoxicity
4. possible correlation between presence of immune cells and clinical prognostic factors

Investigators will collect:

1. patients with kidney cancer:

   * blood,
   * urine,
   * kidney tissue removed during operation (healthy kidney tissue, carcinomatous tissue and tissue form the border)
2. healthy control:

   * blood

Cellular Immunity and Renal Cell Cancer

NK Cells, Tumor Infiltrating Lymphocytes and Cell Cytotoxicity in Renal Cell Cancer - Observational Study

All included patients will signed informed consent. Individual participant data will not be shared with other researchers.

Determination of distribution of immune cells between two groups in their blood samples with their comparison.

Determination of distribution of immune cells between different tissue samples with their comparison

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
In Vitro Study of Peripheral Blood Mononuclear Cell Function in Healthy Individuals and Patients	NCT00342485	Cell Function		18 Years -	National Institutes of Health Clinical Center (CC)
Studies of the Immune Response in Normal Subjects and Patients With Disorders of the Immune System	NCT00001158	Immunologic Def... Neoplasms		-	National Institutes of Health Clinical Center (CC)
Study of the Humoral Response to SARS-CoV-2 Variants and of the Cellular Response After Vaccination Against COVID-19 in Immunocompromised People	NCT04844489	Autoimmune or A... HIV Multiple Sclero... Solid Tumors or... Solid Organ Tra...	Blood samples f...	18 Years -	Assistance Publique - Hôpitaux de Paris
Prospective Comparison of Immunological Benefit of Laparoscopic Colectomy	NCT00744159	Immunity		20 Years - 80 Years	Samsung Medical Center
In Vitro Studies of Immunological and Stem Cell Function in Peripheral Blood Mononuclear Cells in Patients	NCT00001336	Immunologic Def... Leukemia Lymphoma Neoplasm		-	National Institutes of Health Clinical Center (CC)
Study of the Humoral Response to SARS-CoV-2 Variants and of the Cellular Response After Vaccination Against COVID-19 in Immunocompromised People	NCT04844489	Autoimmune or A... HIV Multiple Sclero... Solid Tumors or... Solid Organ Tra...	Blood samples f...	18 Years -	Assistance Publique - Hôpitaux de Paris
Cellular Immunity and Renal Cell Cancer	NCT04377113	NK Cell Mediate... NK Cell Cytokin... Kidney Cancer		18 Years -	Clinical Hospital Center Rijeka
Studies of the Immune Response in Normal Subjects and Patients With Disorders of the Immune System	NCT00001158	Immunologic Def... Neoplasms		-	National Institutes of Health Clinical Center (CC)
In Vitro Studies of Immunological and Stem Cell Function in Peripheral Blood Mononuclear Cells in Patients	NCT00001336	Immunologic Def... Leukemia Lymphoma Neoplasm		-	National Institutes of Health Clinical Center (CC)

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