CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Placebo-Controlled and Randomized Phase 2 Trial of CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients After Hematopoietic Stem Cell Transplant
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Donors may optionally undergo blood sample collection on study."
- "Recipients undergo blood sample collection on study."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether giving the CMV-MVA Triplex vaccine to stem cell donors helps prevent CMV, a viral infection, in transplant patients. It is for adults with certain blood cancers who will receive stem cells from a closely tissue-matched relative. Researchers hope the donor can pass protection against CMV to the patient through the transplant.
This phase II clinical trial tests how well the cytomegalovirus-modified vaccinica Ankara (CMV-MVA) Triplex vaccine given to human leukocyte antigens (HLA) matched related stem cell donors works to prevent cytomegalovirus (CMV) infection in patients undergoing hematopoietic stem cell transplant. The CMV-MVA Triplex vaccine works by causing an immune response in the donors body to the CMV virus, creating immunity to it. The donor then passes that immunity on to the patient upon receiving the stem cell transplant. Giving the CMV-MVA triplex vaccine to donors may help prevent CMV infection of patients undergoing stem cell transplantation.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Donors and patients: Must be age 18 or older and give written consent, either themselves or through a legal representative.
- Patients: Must agree to study visits and follow-up for one year after the transplant.
- Patients: Must be able to care for themselves or do most daily tasks, based on a required activity score.
- Patients: Must have a planned transplant for certain blood cancers, including lymphoma, leukemia, myelodysplastic syndrome, myeloproliferative disorders, or myelofibrosis. Some cancers must be at a specific stage or in remission.
- Patients: Must have a positive CMV antibody test and a related donor who matches all 8 required tissue markers.
- Patients: Liver, kidney, heart, and lung tests must meet the study's limits.
- Patients: Must meet infection testing rules. HIV, hepatitis B, or hepatitis C screening that is positive requires testing showing no detectable virus. A negative syphilis test is required.
- Patients: Those who can become pregnant need a negative pregnancy test. Those who could have a child must use effective birth control or avoid sex that could cause pregnancy before joining and for up to 90 days after transplant.
Who can't join
- Donors: Any past transplant; chemotherapy, radiation, biological therapy, or immune treatment within 21 days before study treatment; or another vaccine within 30 days before or after the study vaccine.
- Donors: Health problems that make stem cell collection unsafe, certain abnormal heart findings, or sickle cell disease or trait.
- Donors: HIV, active hepatitis B, hepatitis C, or HTLV-I/II infection.
- Donors and patients: Pregnancy, breastfeeding, or other safety concerns. Also excluded if they cannot follow study steps; donors cannot join if a severe mental health or thinking problem prevents consent or donation.
- Patients: Multiple myeloma, an autoimmune disease in which the body attacks itself, or a past stem cell transplant from another person.
- Patients: A past experimental CMV vaccine or experimental drug treatment for CMV within the last 6 months.
- Patients: Certain vaccines or allergy shots; alemtuzumab or similar drugs that remove immune cells; or drugs or antibody treatments used to treat or prevent CMV. Acyclovir to prevent herpes simplex is allowed.
- Patients: Other study drugs with unknown effects on CMV or unknown side effects, or medicines that could interfere with judging the study treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * DONORS: Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * DONORS: Age: 18 and above * RECIPIENTS: Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * RECIPIENTS: Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT * RECIPIENTS: Age: 18 and above * RECIPIENTS: Karnofsky performance score ≥ 70 or ECOG ≤ 2 * RECIPIENTS: Planned HCT for the treatment of the following hematologic malignancies: lymphoma (Hodgkin and Non-Hodgkin), myelodysplastic syndrome, acute lymphoblastic leukemia in first or second remission, acute myeloid leukemia in first or second remission, chronic myelogenous leukemia (in first chronic or accelerated phase, or in second chronic phase), chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis. Patients with multiple myeloma are excluded * RECIPIENTS: CMV seropositive * RECIPIENTS: Planned related HCT with 8/8 (A, B, C, DRB1) high resolution human leukocyte antigen (HLA) donor allele matching * RECIPIENTS: Conditioning and immunosuppressive regimens according to institutional guidelines are permitted. Patients may receive myeloablative, reduced intensity, or nonmyeloablative conditioning * RECIPIENTS: Total bilirubin ≤ 2 X upper limit of normal (ULN) (unless has Gilbert's disease) * RECIPIENTS: Aspartate aminotransferase (AST) ≤ 2.5 x ULN * RECIPIENTS: Alanine aminotransferase (ALT) ≤ 2.5 x ULN * RECIPIENTS: Creatinine clearance of ≥ 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula * RECIPIENTS: Left ventricular ejection fraction (LVEF) ≥ 50% Note: To be performed within 45 days prior to day 1 of protocol therapy * RECIPIENTS: If able to perform pulmonary function tests: forced vital capacity (FVC) and diffusion capacity of carbon monoxide (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin). If unable to perform pulmonary function tests: oxygen (O2) saturation \> 92% on room air Note: To be performed within 45 days prior to day 1 of protocol therapy * RECIPIENTS: Seronegative for human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV)\*, active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \[RPR\]) * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable * RECIPIENTS: Meets other institutional and federal requirements for infectious disease titer requirements Note: Infectious disease testing to be performed within 45 days prior to day 1 of protocol therapy * RECIPIENTS: Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * RECIPIENTS: Agreement by females and males of childbearing potential\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and for up to 90 days post-HCT. * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) Exclusion Criteria: * DONORS: Any prior transplant to day 1 of protocol therapy * DONORS: Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy * DONORS: Receipt of any vaccine (licensed or investigational) within 30 days prior to and after of the study vaccine * DONORS: Unfit to undergo standard stem cell mobilization and apheresis e.g. abnormal blood counts, history of stroke, uncontrolled hypertension * DONORS: Sickling hemoglobinopathy including hemoglobin S (HbSS), sickle cell trait (HbAS), hemoglobin sickle C disease (HbSC) * DONORS: Donors with impaired cardiac function are excluded. Electrocardiography is routine for potential HCT donors over 60 years old and those with a history of heart disease. Subjects in whom cardiac function is abnormal (excluding 1st degree branch block, sinus bradycardia, sinus tachycardia or non-specific T wave changes) are ineligible for Triplex vaccination * DONORS: Positive for HIV, active hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-I/II) * DONORS: Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the donation procedure unlikely, and making informed consent impossible * DONORS: Females only: Pregnant or breastfeeding * DONORS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * DONORS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics) * RECIPIENTS: Any prior investigational CMV vaccine * RECIPIENTS: Experimental anti-CMV chemotherapy in the last 6 months * RECIPIENTS: Prior allogeneic (allo) transplant for any condition * RECIPIENTS: Live attenuated vaccines * RECIPIENTS: Medically indicated subunit (Engerix-B for HBV; Gardasil for HPV) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections) * RECIPIENTS: Allergy treatment with antigens injections * RECIPIENTS: Alemtuzumab or any equivalent in vivo T-cell depleting agent * RECIPIENTS: Antiviral medications with known therapeutic effects on CMV such as valganciclovir/ganciclovir (GCV/VAL), foscarnet (FOS), cidofovir, brincidofovir (CMX-001), maribavir. Acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV) * RECIPIENTS: Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment * RECIPIENTS: Other investigational product - concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited * RECIPIENTS: Other medications that might interfere with the evaluation of the investigational product * RECIPIENTS: Diagnosis with autoimmune disease * RECIPIENTS: Females only: Pregnant women and women who are lactating. The risks of Triplex to pregnant women are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother. Breastfeeding should be discontinued if the mother is enrolled on this study * RECIPIENTS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * RECIPIENTS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Study sites (3)
CA
- City of Hope Medical Center · Duarte, CA 91010Vaibhav Agrawal · Study contact · 626-256-4673 ext. 62705 · vagrawal@coh.orgVaibhav Agrawal · Principal investigatorMore trials in Duarte
GA
- Northside Hospital · Atlanta, GA 30342Scott R. Solomon, MD · Study contact · 404-255-1930 · ssolomon@bmtga.comScott R. Solomon · Principal investigatorMore trials in Atlanta
MA
- DFCI/BWH Brigham and Women's Hospital · Boston, MA 02115Lindsey Baden, MD · Study contact · 617-732-6801 · lbaden@bwh.harvard.eduLindsey Baden, MD · Principal investigatorMore trials in Boston