Assessment of humoral immunity to poliomyelitis, tetanus, hepatitis B, measles, rubella, and mumps in children after chemotherapy.
Matteo Zignol, Marta Peracchi, Gloria Tridello...
https://pubmed.ncbi.nlm.nih.gov/15274078Actively Recruiting
Age: 0 - 12Years
All Genders
Healthy Volunteers
ID05351216
The Effect of Sirolimus on Time-sequentially Scheduled Immunizations During the Treatment of Kaposiform Hemangioendothelioma: a Case-control Study
Led by Children's Hospital of Fudan University · Updated on 2025-06-27
174
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the antibody protection and immune memory after vaccination in children with Kaposiform Hemangioendothelioma (KHE) who are receiving sirolimus treatment. The study aims to explore the safety and effectiveness of timely vaccinations during sirolimus administration and to find alternative vaccination plans for KHE patients on sirolimus who do not respond to primary vaccinations. KHE mainly affects infants and young children under 1 year old, with a significant portion being neonates. Sirolimus suppresses the immune system, often leading to paused vaccinations and leaving children vulnerable to infections. The study addresses concerns about live vaccines causing severe infections and the loss of immune memory commonly seen in patients receiving immunosuppressive treatments.
CONDITIONS
Brief Title
The Effect of Sirolimus on Immunizations During the Treatment of Kaposiform Hemangioendothelioma
Who Can Participate
Age: 0 - 12Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Children with Kaposiform Hemangioendothelioma (KHE) treated with sirolimus.
- Participants must have immunoglobulin and flow cytometry tests and outpatient evaluation.
- Participants will receive live or inactivated vaccines as advised.
- Healthy children without immune deficiencies.
- Healthy children vaccinated according to the National Immunization Program.
- Participants are age-matched to the case group, up to 12 years old.
You will not qualify if you...
- Positive for HBsAg, HBeAg, or having other active infections.
- History of immunodeficiency or low immunoglobulin levels.
- Autoimmune disease or fever at blood collection.
- Use of other medications or recent surgery.
- Other bleeding disorders.
- Other solid tumors or blood-related tumors.
- Withdrawal of informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 1 day
Participants undergo immunoglobulin and flow cytometry tests, outpatient evaluation, and assessment before vaccination.
1 visit (in-person)
Long-term Monitoring
Duration - 18 months
Participants receive vaccinations as advised and have antibody levels measured to assess immune response over time.
Visits at admission and at 7, 12, and 18 months after admission
Trial Site Locations
Total: 1 location
1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Actively Recruiting
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Research Team
K
Kai Li, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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