Clinical trial · Interventional
Cytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
A Phase 2 Clinical Trial to Evaluate the Safety, Immunogenicity, and Clinical Benefit of a CMV Immunotherapeutic Vaccine in Donors and CMV-Seropositive Recipients Undergoing Allogeneic, Matched Hematopoietic Cell Transplant (HCT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this trial is to evaluate a CMV vaccine given to related donor/recipient pairs (donors prior to peripheral blood stem cell donation and CMV-seropositive recipients just before and after transplantation) and CMV-seropositive recipient-only subjects (related or unrelated) to determine incidence rates of CMV infection, disease, and other complications from immunosuppression and/or transplantation. The outcomes for the groups receiving CMV vaccine will be compared to the outcomes for the group that received the placebo vaccine to see if there is a clinical benefit. For this trial, donors and recipients must have matched HLA genotype (matched at 5/6 or 6/6 HLA loci).
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hodgkin's Lymphoma | Hodgkin Lymphoma | ALIAS | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phosphate-buffered Saline (PBS) | Other | — | UNRESOLVED |
| VCL-CB01 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- VCL-CB01
- interventionNames
- Biological: VCL-CB01
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- PBS
- interventionNames
- Other: Phosphate-buffered Saline (PBS)
Primary outcomes (2)
- measure
- Safety of CMV immunotherapeutic vaccine in donors and recipients undergoing HCT
- timeFrame
- 1 year
- measure
- occurrence rate of clinically significant CMV viremia in recipients receiving CMV immunotherapeutic vaccine.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * males and females age 18-65 * 5/6 or 6/6 classic HLA allele-matched donor * planned GCSF-mobilized peripheral blood stem cell transplant * CMV-seropositive recipient * planned transplant with minimal or no T-cell depletion * Acute Lymphoblastic Leukemia (ALL) in first or second remission; Acute Myeloid Leukemia (AML) in first or second remission; Chronic Myelogenous Leukemia (CML) in first chronic or accelerated phase, or in second chronic phase; Hodgkin's and non-Hodgkin's lymphoma; myelodysplastic syndrome Exclusion Criteria: * planned prophylactic cytomegalovirus antiviral therapy * planned immunosuppression with alemtuzumab (CAMPATH-IH) * planned prophylactic therapy with CMV immunoglobulin * autoimmune disease
References
Publications (1)
- BACKGROUNDKharfan-Dabaja MA, Boeckh M, Wilck MB, Langston AA, Chu AH, Wloch MK, Guterwill DF, Smith LR, Rolland AP, Kenney RT. A novel therapeutic cytomegalovirus DNA vaccine in allogeneic haemopoietic stem-cell transplantation: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2012 Apr;12(4):290-9. doi: 10.1016/S1473-3099(11)70344-9. Epub 2012 Jan 10. PMID 22237175