Monitoring of Measles-specific Immune Status in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients

Launched by HOSPICES CIVILS DE LYON · Jul 7, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether adults who have received a specific type of stem cell transplant (called allogeneic hematopoietic stem cell transplant) may still have some immune protection against measles even after several years. Measles can be a serious illness, especially for these patients, and health authorities recommend that they get vaccinated against measles, mumps, and rubella (MMR) starting 24 months after their transplant. However, there is some debate among experts about whether testing for measles antibodies first would help avoid unnecessary vaccinations for those who are still protected.

To be eligible for the study, participants must be between 18 and 75 years old, have had their transplant at least 24 months ago, and be in good health without severe complications from the transplant. They also need to be able to attend study visits and give their consent. Participants can expect to undergo tests to check their immune status regarding measles and may receive guidance based on the study findings. This trial is important as it aims to clarify the best approach to measles vaccination for these patients, balancing safety and the need for protection against the virus.

Gender

ALL

Eligibility 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.