NCT01770119

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

9 years

First QC Date

January 15, 2013

Last Update Submit

September 16, 2020

Conditions

Measles

Keywords

MeaslesMumpsRubellaPediatricSolid-organ transplantserologyvaccine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Persistance of seroresponse to MMR vaccine

    3 years

Other Outcomes (1)

  • Efficacy of MMR vaccine in pediatric SOT recipients

    3 years

Study Arms (1)

MMR vaccination

EXPERIMENTAL

MMR vaccine to seronegative pediatric SOT recipients

Biological: MMR vaccination

Interventions

MMR vaccinationBIOLOGICAL

Unprotected children will be vaccinated with two MMR vaccines

MMR vaccination

Eligibility Criteria

Age12 Months - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

Related 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.

    PMID: 30171797BACKGROUND

  • 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.

    PMID: 31497926BACKGROUND

MeSH Terms

Conditions

MeaslesMumpsRubella

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRubulavirus InfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesRubivirus InfectionsTogaviridae Infections

Study Officials

  • Klara M Posfay-Barbe, MD, MS

    University Hospitals of Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Pediatric Infectious Diseases

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2022

Study Completion

October 1, 2025

Last Updated

September 18, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)