Monitoring measles immunity in adult stem cell transplant recipients
Monitoring of Measles-specific Immune Status in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients: a Prospective Cohort Study
This study is testing whether adult stem cell transplant recipients still have immunity to measles so they can avoid unnecessary revaccination if they are already protected.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Lyon) |
| Trial ID | NCT05947864 on ClinicalTrials.gov |
What this trial studies
This study focuses on assessing the measles-specific immune status in adult patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT). It aims to determine whether these patients still have immunity to measles before considering revaccination, as current guidelines recommend revaccination regardless of serostatus. The study will involve collecting biological samples, including blood and oral fluid, to evaluate measles antibody levels. The goal is to avoid unnecessary revaccination in patients who are already seropositive.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 who have received an allo-HSCT at least 24 months prior and are in complete remission without extensive chronic graft-versus-host disease.
Not a fit: Patients with a history of autoimmune diseases or those currently undergoing immunosuppressive treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help tailor vaccination strategies for allo-HSCT recipients, potentially reducing unnecessary medical interventions.
How similar studies have performed: While there is ongoing debate about the necessity of systematic measles antibody assessment, similar studies have not yet established a consensus on this approach, making this study relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Study population: * Aged ≥ 18 years and ≤ 75 years, * Have received an allo-HSCT ≥ 24 months ago, * In complete remission of initial hematologic disease and with successful engraftment (recipient chimerism \<0.3% on whole blood), * Without extensive chronic GVHD, * Having given their written consent, * Affiliated to a social security plan, * Able to attend all scheduled visits and to comply with all study procedures. Healthy volunteers: * Aged ≥ 18 years and ≤ 75 years, * Having a history of measles (=convalescent) or have been vaccinated in the past with two doses of MMR (=vaccinated), * Having given their written consent, * Affiliated to a social security plan. Exclusion Criteria: Study population: * History of autoimmune disease or acquired immunodeficiency (other than the hematological disease), * Patients undergoing pharmacological immunosuppression or biotherapy or extracorporeal photopheresis at the time of inclusion, or whose immunosuppressive treatment (corticosteroids and anti-rejection agents) has been stopped less than 3 months ago, or whose biotherapy (anti-cytokines, anti-JAK, anti-CD20 etc.) has been stopped less than 3 months ago (12 months for anti-CD20 including rituximab), or whose extracorporeal photopheresis has been stopped less than 3 months ago, * Patients having received ≥ 1 infusion of IVIG in the 8 months prior to inclusion, * Patients whose last HSCT was an autograft, * Patients with known chronic active infection with human immunodeficiency virus (HIV) and/or hepatitis B or C virus(es), * Patients deprived of liberty by judicial or administrative decision, * Patients under legal protection or unable to consent to the study, * Patients participating in another interventional research study with an exclusion period still in progress at pre-inclusion, * Pregnant, parturient or breast-feeding women. Healthy volunteers: * History of autoimmune disease or acquired immunodeficiency, * History of pharmacological immunosuppression or biotherapy discontinued less than 3 months ago (12 months for anti-CD20 including rituximab), * History of IVIG infusion in the 8 months prior to inclusion, * Persons deprived of liberty by judicial or administrative decision.
Where this trial is running
Lyon
- Hôpital de la Croix Rousse - service des maladies infectieuses et tropicales — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Anne CONRAD — Hospices Civils de Lyon
- Study coordinator: Anne CONRAD
- Email: anne.conrad@chu-lyon.fr
- Phone: +33 4 72 07 11 07
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.