Clinical trial
A Prospective Cohort Study of Efficacy, Safety and Characterization of Immune Response to Vaccinations in Hematopoietic Stem Cell Transplant Recipients
Name
69HCL17_0769
Description
Hematopoietic stem cell transplantation (HSCT) is a cellular therapy aiming at curing some hematological diseases. Upon transplantation, recipients experience a phase of profound immune suppression with loss of protective immunity against most infectious agents. Revaccination of HSCT recipients against vaccine-preventable infections is an important post-transplant intervention for reducing morbi-mortality. The VaccHemInf project aims at assessing the efficacy of recommended vaccines in adult recipients of HSCT, through the antibody titers reference method and a panel of immune functional assays.
Trial arms
Trial start
2018-04-27
Estimated PCD
2021-01-21
Trial end
2023-01-21
Status
Completed
Treatment
immune biomarkers to evaluate vaccine response in HSCT recipients
a 38mL-blood sample will be collected before and at 3, 12 and 24 months after complete block vaccination and at 4 weeks after influenza vaccination for the ancillary study
Arms:
hematopoietic stem cell transplant (HSCT)
Size
152
Primary endpoint
proportion of responders defined by the increase in specific antibody titers at 3 months after full block vaccination including tetanus, diphtheria, Pneumococcus, Haemophilus influenza type B (Hib), and hepatitis B virus (HBV).
at 3 months after block vaccination
Eligibility criteria
Inclusion Criteria:
* allogeneic and autologous HSCT recipients
* ≥ 18 year-old
* patients having been informed of the conditions of the study (24-month follow-up) and having signed the informed consent form
* Person with social security insurance
• Additional inclusion criteria for healthy volunteers enrolled (10 volunteers)in the ancillary study of influenza vaccine response:
* health-care workers recruited from the hospital staff
Exclusion Criteria:
* Patient with innate or acquired immune deficiency (severe combined immunodeficiency, Hepatitis C virus (HCV), HBV, HIV infections at any stage)
* Pregnant or breastfeeding women
* History of previous severe allergic reaction to vaccine components
* Patient with no social security coverage, with restricted liberty or under legal protection.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 152, 'type': 'ACTUAL'}}
Updated at
2024-03-20
1 organization
1 product
2 indications
Organization
Hospices Civils de LyonProduct
Immune BiomarkersIndication
VaccinationIndication
Hematopoietic Stem Cells