Monitoring of Measles-specific Immune Status in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients: a Prospective Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

⁃ 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.

Locations
Other Locations
France
Hôpital de la Croix Rousse - service des maladies infectieuses et tropicales
RECRUITING
Lyon
Contact Information
Primary
Anne CONRAD
anne.conrad@chu-lyon.fr
+33 4 72 07 11 07
Backup
Florence ADER
florence.ader@chu-lyon.fr
+33 4 72 07 11 07
Time Frame
Start Date: 2023-08-17
Estimated Completion Date: 2026-07
Participants
Target number of participants: 60
Treatments
Experimental: Allo-HSCT recipients
Adult recipients of allogenic hematopoietic stem cell transplantation, eligible for live-attenuated vaccines, i.e. who are more than 24 months after their HSCT, without GVHD and more than 3 months after cessation of any immunosuppressant treatment
Placebo_comparator: Healthy volunteers (HV)
Healthy adults with a history of measles (=convalescents) or vaccinated with two doses of MMR in the past (=vaccinated)
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov