New vaccine aims to shield transplant patients from deadly virus
NCT ID NCT02506933
First seen Jun 25, 2026 · Last updated Jul 29, 2026 · Updated 3 times
Summary
This phase II trial tests a vaccine designed to protect stem cell transplant recipients from cytomegalovirus (CMV), a common virus that can cause serious illness in people with weakened immune systems. The vaccine uses a modified, harmless virus to deliver three CMV proteins, training the immune system to fight off CMV. About 100 participants who have had a stem cell transplant will receive either the vaccine or a placebo, and researchers will monitor for CMV infections and other complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CMV-MVA Triplex Vaccine
- What this could lead to
- If it works, this vaccine could help prevent dangerous CMV infections in stem cell transplant patients, reducing the need for antiviral drugs and improving recovery.
- What could go wrong
- This is a phase II trial with only 102 participants, so results may not apply to everyone. The vaccine may not provide enough protection, and there is a risk of side effects like graft-versus-host disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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102 people
The number who actually took part.
- Started
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Dec 2015
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * All subjects must have the ability to understand and the willingness to sign a written informed consent * Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT * 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 (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood; persistent lymphadenopathy on computed tomography \[CT\] or CT/positron emission tomography (PET) scan without progression is allowed) * Acute myeloid leukemia in first or second remission * Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase * Other hematologic malignancies including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis; patients with multiple myeloma and those with non-malignant disease such as aplastic anemia are excluded * Patients undergoing a second allogeneic (allo) HCT are not eligible (patients who have undergone a previous autologous HCT are eligible) * CMV seropositive (recipient) * Planned related or unrelated HCT, with 8/8 (A,B,C,DRB1) high/intermediate resolution HLA donor allele matching * Planned HCT with minimal to no-T cell depletion of graft * Conditioning and immunosuppressive regimens according to institutional guidelines are permitted * Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within two weeks of registration * Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and active hepatitis B virus (HBV) (surface antigen negative) within 2 months of registration * Agreement by females of childbearing potential and sexually active males to use an effective method of contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for up to 90 days post-HCT; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately Exclusion Criteria: * Any prior investigational CMV vaccine * Experimental anti-CMV chemotherapy in the last 6 months * Live attenuated vaccines * Medically indicated subunit (Engerix-B for HBV; Gardasil for human papillomavirus \[HPV\]) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections) * Allergy treatment with antigens injections * Alemtuzumab or any equivalent in vivo T-cell depleting agent * Antiviral medications with known therapeutic effects on CMV such as ganciclovir (GCV)/valganciclovir (VAL), foscarnet (FOS), Cidofovir, CMX-001, maribavir; acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV) * Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment * 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 * Other medications that might interfere with the evaluation of the investigational product * Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years are not eligible * Pregnant women and women who are lactating; breastfeeding should be discontinued if the mother is enrolled on this study * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social/ psychological issues, etc * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope Medical Center
Duarte, California, 91010, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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- Patient's own t cells engineered to hunt lymphoma in early trial
- Tweaking donor cells may shield older transplant patients from a dangerous complication