MeaslesPhase 4MMRinOLTNCT01770119
Induction of Immunity Against Measles in Pediatric Liver Transplant Recipients
A Phase 4 study testing MMR vaccination in people with Measles, run by Klara M. Pósfay Barbe at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 12 months to 20 years
- Conditions the study is for
- Measles
- What is being tested?
- MMR vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2013to Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 If the child receives measles-containing Ig before an additional dose of MMR vaccine, he/she will be withdrawn from the study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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Children's Hospital of Geneva
Geneva, Canton of Geneva, 1211
Klara M Posfay-Barbe, MD, MS, +41223725462, Klara.PosfayBarbe@hcuge.ch
Natasha Loevy, MD, +41223725481, Natasha.Loevy@hcuge.ch
About this study
Official title: Induction and Maintenance of Immunity Against Measles in Pediatric Orthotopic Liver Transplantation Recipients: a Prospective Nationwide Study in Switzerland
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.
Read the 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.
- Conditions
- Measles
- Being tested
- MMR vaccination
- Keywords
- Measles, Mumps, Rubella, Pediatric, Solid-organ transplant, serology, vaccine
- Medical subject headings
- Measles, Mumps, Rubella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMR vaccinationBiological
Unprotected children will be vaccinated with two MMR vaccines
| Study group | Role | What they receive |
|---|---|---|
| MMR vaccination | Experimental | MMR vaccine to seronegative pediatric SOT recipients Receives: Biological: MMR vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months after vaccination
Secondary outcomes (1)
Persistance of seroresponse to MMR vaccine
Seroresponse to MMR vaccine will be followed over time in pediatric transplant recipients
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2022 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MeaslesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klara M. Pósfay Barbe
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor-investigator, Klara M. Pósfay Barbe, University Hospital, Geneva
- Investigators
- Klara M Posfay-Barbe, MD, MS, Principal investigator, University Hospitals of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770119
- Sponsor's protocol ID
- MMR in pediatric OLT
- Other IDs
- 12-226 (MatPed 12-048)
- Acronym
- MMRinOLT
- Status last verified
- Sep 2020
- First submitted
- 15 Jan 2013
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30171797Suresh 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.
PubMed 31497926
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction and Maintenance of Immunity Against Measles in Pediatric Orthotopic Liver Transplantation Recipients: a Prospective Nationwide Study in Switzerland
- ClinicalTrials.gov ID
- NCT01770119
- Acronym / sponsor ID
- MMRinOLT / MMR in pediatric OLT
- Conditions
- Measles
- Keywords
- Measles, Mumps, Rubella, Pediatric, Solid-organ transplant, serology, vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Klara M. Pósfay BarbeUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- Apr 2013
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 17 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MMR vaccination | Experimental | Biological: MMR vaccinationMMR vaccine to seronegative pediatric SOT recipients |
Who may qualify
- Ages
- 12 months to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMR vaccinationUnprotected children will be vaccinated with two MMR vaccines | Biological | MMR vaccination |
Primary outcome
serologic response to MMR vaccine in seronegative transplant recipients
Time frame: 2 months after vaccination
Pediatric transplant recipients will be vaccinated with MMR vaccine (previously seronegative) and their seroresponse will be measured 2 months later
1 secondary outcome
Persistance of seroresponse to MMR vaccine
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Background: PubMed 30171797Pittet 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.
- Background: PubMed 31497926Suresh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klara M Posfay-Barbe, MD, MS principal investigator
University Hospitals of Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MMR vaccination in people with Measles, run by Klara M. Pósfay Barbe at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serologic response to MMR vaccine in seronegative transplant recipients (time frame: 2 months after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01770119, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.