Immune ResponsePEDIMMCONCT04916847
Comparative Analysis of Anti-COVID-19 (Severe Acute Respiratory Syndrome) Humoral and Memory T Cell Responses in Children With Various Degrees of Immunosuppression:
An observational study of Immune Response, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 day to 15 years
- Conditions the study is for
- Immune Response
- What is being tested?
- blood collection
- How many people
- 205 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2021to 7 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 15 years
- All sexes
- Child
Study population: 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. To these purpose, the study will benefit from a Network of Pediatric Physicians used to work or collaborating together, with experience of children's studies and strong adherence to the study.
Who may be able to join
- Children over 0 days and under 16 years of age seen in consultation for the follow-up of their pathology or immunosuppressive treatment (see above, Groups of patients).
- Several cases groups will be considered in this study, presented with immunocompromised state or immunosuppressive treatment (i. e. children with: HIV infection, Hematologic Malignancy treated by conventional chemotherapy, Hematologic pathology treated by allogenic stem cell transplantation, inflammatory bowel disease treated by anti-TNF, idiopathic juvenile arthritis treated by methotrexate, treated by renal transplantation; see above, paragraph groups of patients for details).
- Children over 0 days and under 16 years of age considered as control will be non-immunosuppressed children without chronic inflammation, attending consultation for preoperative assessment or congenital abnormalities of the kidney and urinary tract, for Nephropathies without renal impairment (eDFG > 45mL/min/1.73m), for non-inflammatory intestinal (polyposis, Chronic intestinal pseudo-obstruction, short bowel syndrome) or pancreatic (hereditary pancreatitis) pathologies.For comparisons, healthy children will be age-matched with each case.
- Informed consent of the holder (s) of the exercise of parental authority
- Affiliation to a social security scheme
Who cannot join
- Children who have a signs of a current infection.
- Use of immunoglobulins or blood products within 3 months prior to enrolment.
- Children who received one or more doses of SARS-Cov-2 vaccine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of Anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome) Humoral and Memory T Cell Responses in Children With Various Degrees of Immunosuppression: a Case-control Study
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.
Read the detailed 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".
- Conditions
- Immune Response
- Being tested
- blood collection
- Keywords
- children, SARS-CoV-2, Immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood collectionOther
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:
- Specific antibody responses (IgM, IgG, and immunoglobulin A (IgA) anti SARS-Cov-2) by quantitative chemiluminescence analysis.
- Protective neutralizing capacity of these antibodies (neutralizing antibodies against SARS-cOV-2) by neutralization test.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| children with controlled HIV | Children over 0 days and under 16 years old, with controlled HIV Receives: Other: blood collection | |
| children with hematologic Malignancy treated by conventional chemotherapy | Children over 0 days and under 16 years old, with Hematologic Malignancy treated by conventional chemotherapy Receives: Other: blood collection | |
| Children with inflammatory bowel disease treated by anti-TNF at least 6 weeks | Children over 0 days and under 16 years old, with inflammatory bowel disease treated by anti-TNF Receives: Other: blood collection | |
| Children with idiopathic juvenile arthritis | Children over 0 days and under 16 years old, with idiopathic juvenile arthritis treated by methotrexate: Receives: Other: blood collection | |
| Children treated by renal transplantation | Children over 0 days and under 16 years old, treated by renal transplantation from more than 3 months: Receives: Other: blood collection | |
| Children attending consultation | Children over 0 days and under 16 years old, without immunodepression or chronic inflammation attending consultation for :
* preoperative assessment
* -congenital abnormalities of the kidney and urinary tract:
* Nephropathies without renal impairment (eDFG > 45mL/min/1.73m2)
* Non-inflammatory intestinal (polyposis, Chronic intestinal pseudo-obstruction, short bowel syndrome) or pancreatic (hereditary pancreatitis) pathologies This group of children will be a control group (age matched healthy children, non-immunosuppressed). Receives: Other: blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of subjects with positive IgM
Numbers of subjects with positive IgM titer levels against SARS-Cov-2 (according to the manufacturer) at baseline.
Measured: at baseline
Secondary outcomes (3)
Numbers of subjects with positive IgG
Numbers of subjects with positive immunoglobulin G (IgG) SARS-Cov-2 (according to the manufacturer)
Measured: at baseline and at 12 months
Numbers of subjects with positive titers
Number of subjects with positive titers
Measured: at baseline and at 12 months
Percentage of SARS-CoV-2 memory T
Percentage and counts of SARS-CoV-2 memory T cells in lymphocytes
Measured: at baseline ans at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start7 Jun 2021
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ResponseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carcelain Guislaine, PhD, Study chair, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916847
- Sponsor's protocol ID
- APH210217
- Acronym
- PEDIMMCO
- Status last verified
- Mar 2023
- First submitted
- 27 May 2021
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome) Humoral and Memory T Cell Responses in Children With Various Degrees of Immunosuppression: a Case-control Study
- ClinicalTrials.gov ID
- NCT04916847
- Acronym / sponsor ID
- PEDIMMCO / APH210217
- Conditions
- Immune Response
- Keywords
- children, SARS-CoV-2, Immunosuppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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".
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| children with controlled HIV | – | Other: blood collectionChildren over 0 days and under 16 years old, with controlled HIV |
| children with hematologic Malignancy treated by conventional chemotherapy | – | Other: blood collectionChildren over 0 days and under 16 years old, with Hematologic Malignancy treated by conventional chemotherapy |
| Children with inflammatory bowel disease treated by anti-TNF at least 6 weeks | – | Other: blood collectionChildren over 0 days and under 16 years old, with inflammatory bowel disease treated by anti-TNF |
| Children with idiopathic juvenile arthritis | – | Other: blood collectionChildren over 0 days and under 16 years old, with idiopathic juvenile arthritis treated by methotrexate: |
| Children treated by renal transplantation | – | Other: blood collectionChildren over 0 days and under 16 years old, treated by renal transplantation from more than 3 months: |
| Children attending consultation | – | Other: blood collectionChildren over 0 days and under 16 years old, without immunodepression or chronic inflammation attending consultation for : * preoperative assessment * -congenital abnormalities of the kidney and urinary tract: * Nephropathies without renal impairment (eDFG > 45mL/min/1.73m2) * Non-inflammatory intestinal (polyposis, Chronic intestinal pseudo-obstruction, short bowel syndrome) or pancreatic (hereditary pancreatitis) pathologies This group of children will be a control group (age matched healthy children, non-immunosuppressed). |
Who may qualify
- Ages
- 1 day to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- 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. To these purpose, the study will benefit from a Network of Pediatric Physicians used to work or collaborating together, with experience of children's studies and strong adherence to the study.
Key inclusion criteria (5 listed)
- Children over 0 days and under 16 years of age seen in consultation for the follow-up of their pathology or immunosuppressive treatment (see above, Groups of patients).
- Several cases groups will be considered in this study, presented with immunocompromised state or immunosuppressive treatment (i. e. children with: HIV infection, Hematologic Malignancy treated by conventional chemotherapy, Hematologic pathology treated by allogenic stem cell transplantation, inflammatory bowel disease treated by anti-TNF, idiopathic juvenile arthritis treated by methotrexate, treated by renal transplantation; see above, paragraph groups of patients for details).
- Children over 0 days and under 16 years of age considered as control will be non-immunosuppressed children without chronic inflammation, attending consultation for preoperative assessment or congenital abnormalities of the kidney and urinary tract, for Nephropathies without renal impairment (eDFG > 45mL/min/1.73m), for non-inflammatory intestinal (polyposis, Chronic intestinal pseudo-obstruction, short bowel syndrome) or pancreatic (hereditary pancreatitis) pathologies.For comparisons, healthy children will be age-matched with each case.
- Informed consent of the holder (s) of the exercise of parental authority
- Affiliation to a social security scheme
Key exclusion criteria (3 listed)
- Children who have a signs of a current infection.
- Use of immunoglobulins or blood products within 3 months prior to enrolment.
- Children who received one or more doses of SARS-Cov-2 vaccine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood collectionDepending 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. | Other | Children attending consultation, Children treated by renal transplantation, Children with idiopathic juvenile arthritis, Children with inflammatory bowel disease treated by anti-TNF at least 6 weeks, children with controlled HIV, children with hematologic Malignancy treated by conventional chemotherapy |
Primary outcome
Numbers of subjects with positive IgM
Time frame: at baseline
Numbers of subjects with positive IgM titer levels against SARS-Cov-2 (according to the manufacturer) at baseline.
3 secondary outcomes
Numbers of subjects with positive IgG
Time frame: at baseline and at 12 months
Numbers of subjects with positive titers
Time frame: at baseline and at 12 months
Percentage of SARS-CoV-2 memory T
Time frame: at baseline ans at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carcelain Guislaine, PhD study chair
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Response, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of subjects with positive IgM (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.