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Comparative Analysis of Anti-COVID-19 (Severe Acute Respiratory Syndrome) Humoral and Memory T Cell Responses in Children With Various Degrees of Immunosuppression:

NCT04916847 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 205

Last updated 2023-03-03

No results posted yet for this study

Summary

Adaptive immune responses are essential for clearing viral infections and retention of virus specific memory populations is required for long-term immunity. However, there is still uncertainty about whether adaptive immune responses to SARS-CoV-2 are protective. Such knowledge is of immediate relevance, as it will provide insights into immunity of SARS-CoV-2 infection and thus help define future immunization strategies. Because of the importance of asymptomatic cases in children, a specific study is needed in this population in order to determine their individual and collective protective capacity. This is even truer for immune compromised children that likely have severe forms of the disease with active and prolonged viral replication in whom it is therefore essential to determine the extent of sero conversion but also the quality and duration of the memory responses.

For this purpose, we plan to analyze the anti-SARS-CoV-2 humoral and memory T cell responses, in different groups of immuno-compromized children (i.e with different levels/type of immunosuppression; HIV, renal or stem cell transplantation, anti-TNF or methotrexate treatment) and healthy controls seen in 3 University Hospitals, in order to determine the proportion of children with SARS-CoV-2 specific humoral responses, their protective capacity, the magnitude and the quality of the SARS-Cov-2 memory T cells but also their long term persistence at 1 year.

Conditions

  • Immune Response

Interventions

OTHER

blood collection

Depending on the weight of the child, between 5ml and 15ml of blood will be collected during a blood test necessary for the conventional care of the patient. A second blood sample will be taken one year later. The volume of blood taken does not exceed the volume allowed by the guideline "Ethical considerations for clinical trials of medicinal products conducted in the paediatric population". We will analyse: 1. Specific antibody responses (IgM, IgG, and immunoglobulin A (IgA) anti SARS-Cov-2) by quantitative chemiluminescence analysis. 2. Protective neutralizing capacity of these antibodies (neutralizing antibodies against SARS-cOV-2) by neutralization test. 3. SARS-Cov-2 specific memory T cell responses by multiparametric flow cytometry in order to characterize their maturation, differentiation, senescence, activation, secretion of interleukin (cytokines 2) , IFN-g, TNF) or Interferon-gamma (IFN-g) ELISPOT assay.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Carcelain Guislaine, PhD · APHP

Eligibility

Min Age
1 Day
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-07
Primary Completion
2022-12-07
Completion
2022-12-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04916847 on ClinicalTrials.gov