Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04916847 |
| Other study ID # |
APH210217 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 7, 2021 |
| Est. completion date |
December 7, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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
immuno-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
seroconversion 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.
In this study, we will evaluate the proportion of children who developed anti-SARS-CoV-2
humoral and cellular memory immune responses and the protective capacity of these responses
in different groups of immune-compromised children.
As explained above, clinical significance of SARS-CoV-2 varies among different
immune-compromised populations, in relation to the individual degree and type of
immunosuppression. It is therefore necessary to obtain data on post infection protective
immunity in different groups of immunosuppressed children. The intervention added for this
study, blood samples will be taken. The blood sample will consist of two to three (depending
on weight) additional tubes (heparin-lithium, dry) between 5 ml and 15 ml each taken during a
blood test necessary for the patient's standard care. A second blood sample will be taken one
year later for those with a positive response to SARS-CoV-2 and for vaccinated children. The
volume of blood taken does not exceed the volume allowed by the guideline "Ethical
considerations for clinical trials of drugs in the pediatric population".
