Induction of Immunity Against Measles in Pediatric Liver Transplant Recipients

Measles Clinical Trial

— MMRinOLT  

Official title:

Induction and Maintenance of Immunity Against Measles in Pediatric Orthotopic Liver Transplantation Recipients: a Prospective Nationwide Study in Switzerland

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01770119
• Other study ID #: MMR in pediatric OLT
• Secondary ID: 12-226 (MatPed 1
• Status: Recruiting
• Phase: Phase 4
• Start date: April 2013
• Est. completion date: October 2025

Study information

• Verified date: September 2020
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Measles is a vaccine-preventable disease, which can be life-threatening in immunosuppressed children. Currently, measles vaccine is not recommended in pediatric orthotopic liver transplant recipients, because it is a live-attenuated vaccine.

We want to assess the influence of immunosuppression on immunity against measles in previously vaccinated children and to evaluate the induction of B cell and T cell response against measles elicited by vaccination in children at least 12 months after transplantation.

Description:

Eligible children in Group 2 will receive a standard dose (0.5 ml) of MMR vaccine during the first medical visit (V1). The lot number and the expiration date will both be recorded on the patient's case report form (CRF). A serological evaluation 4-8 weeks after MMR will identify children requiring an additional dose given 1-2 months apart, as currently recommended for subjects 1 year-old or with limited immune competence (i.e. HIV-infected children). Serological evaluation 4-8 weeks after the second dose or at the one-year follow-up will identify eventual non-responder requiring a third dose. Three will be the maximal number of administrated dose according to this protocol. The persistence of measles-specific antibodies will be assessed yearly, when patients come for their routine visit to the transplant center.

Children who do not need MMR immunization because of protective levels will be monitored yearly for maintenance of antibody levels during routine yearly visits/ blood samplings and will not have further intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 2025
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 20 Years

Eligibility

Inclusion Criteria:

• Age = 12 months

• Measles-specific IgG antibodies negative (<0.2 IU/L), as detected by the routine ELISA assay

• = 12 months from the time of transplantation and = 2 months from the time of an acute rejection episode

• Steroids < 2 mg/kg/day, tacrolimus < 0.3mg/kg/day and tacrolimus level < 8 ng/ml for > 1 month.

• Total lymphocyte count = 750 cells/ul at time of immunization

Exclusion Criteria:

• Known wild-type measles exposure during the last four weeks

• Measles-containing immunoglobulins administered within the 5 months preceding the measles vaccine. If the child receives measles-containing Ig before an additional dose of MMR vaccine, he/she will be withdrawn from the study

• Antiviral agents administered during the last four weeks

• Febrile illness (>38.5°) in the 72 hours before vaccine administration

• Chronic aspirin therapy

• Any other immunization with a live-attenuated vaccine during the last four weeks

• Pregnancy

Related Conditions & MeSH terms

• Measles

Intervention

Biological:
• MMR vaccination
Unprotected children will be vaccinated with two MMR vaccines

Locations

Country	Name	City	State
Switzerland	Children's Hospital of Geneva	Geneva	GE

Sponsors (2)

Lead Sponsor	Collaborator
Klara M. Pósfay Barbe	University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Pittet LF, Verolet CM, McLin VA, Wildhaber BE, Rodriguez M, Cherpillod P, Kaiser L, Siegrist CA, Posfay-Barbe KM. Multimodal safety assessment of measles-mumps-rubella vaccination after pediatric liver transplantation. Am J Transplant. 2019 Mar;19(3):844-854. doi: 10.1111/ajt.15101. Epub 2018 Oct 1. — View Citation

Suresh S, Upton J, Green M, Pham-Huy A, Posfay-Barbe KM, Michaels MG, Top KA, Avitzur Y, Burton C, Chong PP, Danziger-Isakov L, Dipchand AI, Hébert D, Kumar D, Morris SK, Nalli N, Ng VL, Nicholas SK, Robinson JL, Solomon M, Tapiero B, Verma A, Walter JE, Allen UD. Live vaccines after pediatric solid organ transplant: Proceedings of a consensus meeting, 2018. Pediatr Transplant. 2019 Nov;23(7):e13571. doi: 10.1111/petr.13571. Epub 2019 Sep 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Efficacy of MMR vaccine in pediatric SOT recipients	Protection against vaccine-preventable diseases will be assessed in pediatric SOT recipients	3 years
Primary	serologic response to MMR vaccine in seronegative transplant recipients	Pediatric transplant recipients will be vaccinated with MMR vaccine (previously seronegative) and their seroresponse will be measured 2 months later	2 months after vaccination
Secondary	Persistance of seroresponse to MMR vaccine	Seroresponse to MMR vaccine will be followed over time in pediatric transplant recipients	3 years