Actively Recruiting
Monitoring of Measles-specific Immune Status in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients
Led by Hospices Civils de Lyon · Updated on 2023-08-22
60
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Measles, a highly contagious disease, is potentially serious in adult allogenic hematopoietic stem cell transplant (allo-HSCT) recipients. Because of the loss of immunity to vaccine preventable diseases after allo-HSCT, French Health Authorities (Haut Conseil de Santé Publique, HCSP) recommend (re)vaccination of all allo-HSCT recipients against measles-mumps-rubella (MMR) from 24 months post-transplant onwards, in the absence of graft-versus-host disease (GVHD) and at least 3 months after cessation of all immunosuppressive treatments, irrespective of measles serostatus. Nevertheless, some French experts argue that systematic assessment of measles antibody titre is justified after allo-HSCT, prior to revaccination, in order to avoid "unnecessary" revaccination of allo-HSCT recipients who are still seropositive. At the international level, recommendations also vary: the ECIL group and IDSA advocate revaccination of measles seronegative patients only, while some American Hematology experts recommend not to base the decision of revaccination on the serological status, given the inevitable loss of antibodies and specific long-term immune memory in the absence of revaccination. Several obstacles to the application of the recommendations can therefore be identified: (i) the risk of vaccine-transmitted disease due to the live-attenuated nature of MMR, (ii) the lack of robust data on the immunogenicity and tolerability of the MMR vaccine in this particular population, and (iii) conflicting recommendations to guide the decision of revaccination. This study aims at answering the question of whether some allo-HSCT recipients may retain a measles-specific cellular immune memory at distance from their allo-HSCT.
CONDITIONS
Official Title
Monitoring of Measles-specific Immune Status in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years and 75 years or younger
- Received an allogeneic hematopoietic stem cell transplant at least 24 months ago
- In complete remission of initial blood disease with successful engraftment (recipient chimerism <0.3% in whole blood)
- No extensive chronic graft-versus-host disease
- Provided written consent
- Affiliated with a social security plan
- Able to attend all visits and follow study procedures
- Healthy volunteers must be aged 18 to 75 years
- Healthy volunteers must have had measles or received two doses of MMR vaccine
- Healthy volunteers must provide written consent and have social security affiliation
You will not qualify if you...
- History of autoimmune disease or acquired immunodeficiency (other than hematological disease)
- Currently using immunosuppressive drugs, biotherapy, or extracorporeal photopheresis, or stopped these treatments less than 3 months ago (12 months for anti-CD20 therapies)
- Received one or more infusions of intravenous immunoglobulin in the 8 months before enrollment
- Last stem cell transplant was an autograft
- Have chronic active infection with HIV or hepatitis B or C viruses
- Under legal detention or deprived of liberty
- Under legal protection or unable to consent
- Participating in another interventional study with an active exclusion period
- Pregnant, giving birth, or breastfeeding
- Healthy volunteers with autoimmune disease, acquired immunodeficiency, recent immunosuppressive treatment, recent IVIG infusion, or legal detention
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Trial Site Locations
Total: 1 location
1
Hôpital de la Croix Rousse - service des maladies infectieuses et tropicales
Lyon, France
Actively Recruiting
Research Team
A
Anne CONRAD
CONTACT
F
Florence ADER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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