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Induction of Immunity Against Measles in Pediatric Liver Transplant Recipients (MMRinOLT)

Primary Purpose

Measles

Status

Recruiting

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

MMR vaccination

About this trial

This is an interventional prevention trial for Measles focused on measuring Measles, Mumps, Rubella, Pediatric, Solid-organ transplant, serology, vaccine

Eligibility Criteria

12 Months - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 If the child receives measles-containing Ig before an additional dose of MMR vaccine, he/she will be withdrawn from the study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

Sites / Locations

Children's Hospital of GenevaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MMR vaccination

Arm Description

MMR vaccine to seronegative pediatric SOT recipients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Persistance of seroresponse to MMR vaccine

Seroresponse to MMR vaccine will be followed over time in pediatric transplant recipients

Full Information

NCT ID

NCT01770119

First Posted

January 15, 2013

Last Updated

September 16, 2020

Sponsor

Klara M. Pósfay Barbe

Collaborators

University Hospital, Geneva

1. Study Identification

Unique Protocol Identification Number

NCT01770119

Brief Title

Induction of Immunity Against Measles in Pediatric Liver Transplant Recipients

Acronym

MMRinOLT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Recruiting

Study Start Date

April 2013 (undefined)

Primary Completion Date

April 2022 (Anticipated)

Study Completion Date

October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Klara M. Pósfay Barbe

Collaborators

University Hospital, Geneva

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Measles

Keywords

Measles, Mumps, Rubella, Pediatric, Solid-organ transplant, serology, vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MMR vaccination

Arm Type

Experimental

Arm Description

MMR vaccine to seronegative pediatric SOT recipients

Intervention Type

Biological

Intervention Name(s)

MMR vaccination

Intervention Description

Unprotected children will be vaccinated with two MMR vaccines

Primary Outcome Measure Information:

Title

serologic response to MMR vaccine in seronegative transplant recipients

Description

Pediatric transplant recipients will be vaccinated with MMR vaccine (previously seronegative) and their seroresponse will be measured 2 months later

Time Frame

2 months after vaccination

Secondary Outcome Measure Information:

Title

Persistance of seroresponse to MMR vaccine

Description

Seroresponse to MMR vaccine will be followed over time in pediatric transplant recipients

Time Frame

3 years

Other Pre-specified Outcome Measures:

Title

Efficacy of MMR vaccine in pediatric SOT recipients

Description

Protection against vaccine-preventable diseases will be assessed in pediatric SOT recipients

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Months

Maximum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Klara M Posfay-Barbe, MD, MS

Organizational Affiliation

University Hospitals of Geneva

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital of Geneva

City

Geneva

State/Province

ZIP/Postal Code

1211

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Klara M Posfay-Barbe, MD, MS

Phone

+41223725462

Klara.PosfayBarbe@hcuge.ch

First Name & Middle Initial & Last Name & Degree

Natasha Loevy, MD

Phone

+41223725481

Natasha.Loevy@hcuge.ch

First Name & Middle Initial & Last Name & Degree

Klara M Posfay-Barbe, MD, MS

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30171797

Citation

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.

Results Reference

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PubMed Identifier

31497926

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, Hebert 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.

Results Reference

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Induction of Immunity Against Measles in Pediatric Liver Transplant Recipients

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