Transplantation, Hematopoietic Stem CellMaRROwVaccNCT05947864
Monitoring of Measles-specific Immune Status in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients
A study testing Biological samples (blood and oral fluid) in people with Transplantation, Hematopoietic Stem Cell, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Transplantation, Hematopoietic Stem Cell
- What is being tested?
- Biological samples (blood and oral fluid)
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 17 Aug 2023to Jul 2026
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- Study population:
- History of autoimmune disease or acquired immunodeficiency (other than the hematological disease),
- Patients undergoing pharmacological immunosuppression or biotherapy or extracorporeal photopheresis at the time of inclusion, or whose immunosuppressive treatment (corticosteroids and anti-rejection agents) has been stopped less than 3 months ago, or whose biotherapy (anti-cytokines, anti-JAK, anti-CD20 etc.) has been stopped less than 3 months ago (12 months for anti-CD20 including rituximab), or whose extracorporeal photopheresis has been stopped less than 3 months ago,
- Patients having received ≥ 1 infusion of IVIG in the 8 months prior to inclusion,
- Patients whose last HSCT was an autograft,
- Patients with known chronic active infection with human immunodeficiency virus (HIV) and/or hepatitis B or C virus(es),
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- Patients deprived of liberty by judicial or administrative decision,
- Patients under legal protection or unable to consent to the study,
- Patients participating in another interventional research study with an exclusion period still in progress at pre-inclusion,
- Pregnant, parturient or breast-feeding women.
- Healthy volunteers:
- History of autoimmune disease or acquired immunodeficiency,
- History of pharmacological immunosuppression or biotherapy discontinued less than 3 months ago (12 months for anti-CD20 including rituximab),
- History of IVIG infusion in the 8 months prior to inclusion,
- Persons deprived of liberty by judicial or administrative decision.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital de la Croix Rousse - service des maladies infectieuses et tropicales
Lyon
Anne CONRAD, Dr, +33 4 72 07 11 07, anne.conrad@chu-lyon.fr
About this study
Official title: Monitoring of Measles-specific Immune Status in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients: a Prospective Cohort Study
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.
- Conditions
- Transplantation, Hematopoietic Stem Cell
- Being tested
- Biological samples (blood and oral fluid)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samples (blood and oral fluid)Biological
For the study population (allo-HSCT recipients): 4 visits with biological sampling (blood and oral fluid) at each visit:
- Visit V1 (inclusion visit = D1): immediately before the first dose of MMR (dose-1),
- Visit V2 (D1 + 35 (+/-7) days): immediately before the second dose of MMR (dose-2)
- Visit V3 (D1 + 70 (+/-14) days)
- Visit V4 (D1 + 365 (+/-90) days) For healthy volunteers: a single visit (V1) with biological sampling (blood and oral fluid)
| Study group | Role | What they receive |
|---|---|---|
| Allo-HSCT recipients | Experimental | 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 Receives: Biological: Biological samples (blood and oral fluid) |
| Healthy volunteers (HV) | Placebo comparator | Healthy adults with a history of measles (=convalescents) or vaccinated with two doses of MMR in the past (=vaccinated) Receives: Biological: Biological samples (blood and oral fluid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined quantification of measles-specific markers of T-cell-mediated immunity (interferon-gamma [IFNγ]-secreting cells; copies of ifnγ mRNA transcripts; amount of IFNγ) and B-cell-mediated immunity (antibody-secreting cells [ASC])
To explore the measles-specific T- and B-cell-mediated systemic immune memory pre-existing to MMR (re)vaccination in allo-HSCT recipients eligible for MMR revaccination according to current French recommendations (i.e., regardless of measles serostatus), T- and B-ELISpot techniques on PBMC, qPCR and cytokine measurement on whole blood, will be performed after ex vivo antigen stimulation
Measured: At Day 1, before routine vaccination with MMR in allo-HSCT recipients
Secondary outcomes (7)
Kinetics of anti-measles total IgG and IgA titers (serum)
To characterize the total measles-specific systemic humoral immune response before and after MMR (re)vaccination, anti-measles antibodies will be measured in serum by ELISA
Measured: At Day 1, Day 35, Day 70 and Day 365 in allo-HSCT recipients
Kinetics of anti-measles neutralizing antibody titers (serum)
To characterize the neutralizing measles-specific systemic humoral immune response before and after MMR (re)vaccination, neutralizing serum antibodies titers will be determined through seroneutralization techniques
Measured: At Day 1, Day 70 and Day 365 in allo-HSCT recipients
Combined quantification of measles-specific markers of T-cell-mediated immunity (IFNγ-secreting cells; copies of ifnγ mRNA transcripts; amount of IFNγ) and B-cell-mediated immunity (ASC) after two doses of MMR
To explore the measles-specific T- and B-cell-mediated systemic immune response after completing MMR (re)vaccination, T- and B-ELISpot techniques on PBMC, qPCR and cytokine measurement on whole blood, will be performed after ex vivo antigen stimulation
Measured: At Day 365, after completion of MMR (re)vaccination schedule in allo-HSCT recipients
Kinetics of anti-measles IgA titers (oral fluid)
To characterize the measles-specific mucosal humoral immune response before and after MMR (re)vaccination, anti-measles IgA will be measured in oral fluid by ELISA
Measured: At Day 1 and Day 70 in allo-HSCT recipients
Difference in immunity markers (total IgG and IgA, neutralizing antibody titers [serum]; IgA titers [oral fluid]; IFNγ-secreting cells; copies of ifnγ mRNA transcripts; amount of IFNγ; ASC) between HV and allo-HSCT recipients
To compare the measles-specific systemic and mucosal immune response between convalescent/vaccinated HV and allo-HSCT recipients, markers of B-cell and T-cell-mediated immunity will be evaluated in convalescent/vaccinated HV at a single timepoint and compared to immunity markers evaluated in allo-HSCT recipients before and after MMR (re)vaccination
Measured: At Day 1 and Day 70
Analysis of measles-specific immunity markers (total IgG and IgA, neutralizing antibody titers [serum]; IgA titers [oral fluid]; IFNγ-secreting cells; copies of ifnγ mRNA transcripts; amount of IFNγ; ASC) according to patient characteristics
To determine the impact of demographic, hematological, transplant-related characteristics, post-transplant complications and measles serostatus on measles-specific B-cell and T-cell immunity markers, before and after MMR (re)vaccination, bivariate and multivariate analysis will be carried out
Measured: At Day 1, Day 35, Day 70 and Day 365 in allo-HSCT recipients
Local and systemic adverse events after the first and the second MMR dose
To describe the tolerance of the two MMR schedule in allo-HSCT recipients, solicited adverse events will be recorded up to day+14 and unsolicited adverse events will be recorded up to day+28 after each MMR dose through self-monitoring
Measured: At Day 35 and Day 70, in allo-HSCT recipients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start17 Aug 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation, Hematopoietic Stem CellStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne CONRAD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947864
- Sponsor's protocol ID
- 69HCL23_0364
- Other IDs
- 2023-A00901-44
- Acronym
- MaRROwVacc
- Status last verified
- Aug 2023
- First submitted
- 28 Jun 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Measles-specific Immune Status in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05947864
- Acronym / sponsor ID
- MaRROwVacc / 69HCL23_0364
- Conditions
- Transplantation, Hematopoietic Stem Cell
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 17 Jul 2023 (actual)
- 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, 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allo-HSCT recipients | Experimental | Biological: Biological samples (blood and oral fluid)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 |
| Healthy volunteers (HV) | Placebo comparator | Biological: Biological samples (blood and oral fluid)Healthy adults with a history of measles (=convalescents) or vaccinated with two doses of MMR in the past (=vaccinated) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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,
Key exclusion criteria (15 listed)
- History of autoimmune disease or acquired immunodeficiency (other than the hematological disease),
- Patients undergoing pharmacological immunosuppression or biotherapy or extracorporeal photopheresis at the time of inclusion, or whose immunosuppressive treatment (corticosteroids and anti-rejection agents) has been stopped less than 3 months ago, or whose biotherapy (anti-cytokines, anti-JAK, anti-CD20 etc.) has been stopped less than 3 months ago (12 months for anti-CD20 including rituximab), or whose extracorporeal photopheresis has been stopped less than 3 months ago,
- Patients having received ≥ 1 infusion of IVIG in the 8 months prior to inclusion,
- Patients whose last HSCT was an autograft,
- Patients with known chronic active infection with human immunodeficiency virus (HIV) and/or hepatitis B or C virus(es),
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 |
|---|---|---|
| Biological samples (blood and oral fluid)For the study population (allo-HSCT recipients): 4 visits with biological sampling (blood and oral fluid) at each visit: * Visit V1 (inclusion visit = D1): immediately before the first dose of MMR (dose-1), * Visit V2 (D1 + 35 (+/-7) days): immediately before the second dose of MMR (dose-2) * Visit V3 (D1 + 70 (+/-14) days) * Visit V4 (D1 + 365 (+/-90) days) For healthy volunteers: a single visit (V1) with biological sampling (blood and oral fluid) | Biological | Allo-HSCT recipients, Healthy volunteers (HV) |
Primary outcome
Combined quantification of measles-specific markers of T-cell-mediated immunity (interferon-gamma [IFNγ]-secreting cells; copies of ifnγ mRNA transcripts; amount of IFNγ) and B-cell-mediated immunity (antibody-secreting cells [ASC])
Time frame: At Day 1, before routine vaccination with MMR in allo-HSCT recipients
To explore the measles-specific T- and B-cell-mediated systemic immune memory pre-existing to MMR (re)vaccination in allo-HSCT recipients eligible for MMR revaccination according to current French recommendations (i.e., regardless of measles serostatus), T- and B-ELISpot techniques on PBMC, qPCR and cytokine measurement on whole blood, will be performed after ex vivo antigen stimulation
7 secondary outcomes
Kinetics of anti-measles total IgG and IgA titers (serum)
Time frame: At Day 1, Day 35, Day 70 and Day 365 in allo-HSCT recipients
Kinetics of anti-measles neutralizing antibody titers (serum)
Time frame: At Day 1, Day 70 and Day 365 in allo-HSCT recipients
Combined quantification of measles-specific markers of T-cell-mediated immunity (IFNγ-secreting cells; copies of ifnγ mRNA transcripts; amount of IFNγ) and B-cell-mediated immunity (ASC) after two doses of MMR
Time frame: At Day 365, after completion of MMR (re)vaccination schedule in allo-HSCT recipients
Kinetics of anti-measles IgA titers (oral fluid)
Time frame: At Day 1 and Day 70 in allo-HSCT recipients
Difference in immunity markers (total IgG and IgA, neutralizing antibody titers [serum]; IgA titers [oral fluid]; IFNγ-secreting cells; copies of ifnγ mRNA transcripts; amount of IFNγ; ASC) between HV and allo-HSCT recipients
Time frame: At Day 1 and Day 70
Analysis of measles-specific immunity markers (total IgG and IgA, neutralizing antibody titers [serum]; IgA titers [oral fluid]; IFNγ-secreting cells; copies of ifnγ mRNA transcripts; amount of IFNγ; ASC) according to patient characteristics
Time frame: At Day 1, Day 35, Day 70 and Day 365 in allo-HSCT recipients
Local and systemic adverse events after the first and the second MMR dose
Time frame: At Day 35 and Day 70, in allo-HSCT recipients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
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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.
Anne CONRAD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological samples (blood and oral fluid) in people with Transplantation, Hematopoietic Stem Cell, run by Hospices Civils de Lyon at 1 site in France.
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 13 inclusion and 15 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 22 Aug 2023. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Anne CONRAD (+33 4 72 07 11 07, anne.conrad@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined quantification of measles-specific markers of T-cell-mediated immunity (interferon-gamma [IFNγ]-secreting cells; copies of ifnγ mRNA transcripts; amount of IFNγ) and B-cell-mediated immunity (antibody-secreting cells [ASC]) (time frame: At Day 1, before routine vaccination with MMR in allo-HSCT recipients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2023.