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BZLF1 Peptide Vaccine (OSU-2131) With QS-21 for the Prevention of Epstein-Barr Virus Related Cancer in Patients Awaiting Solid Organ Transplants

StatusRecruiting
PhasePhase 1
Started2026-06-28
View on ClinicalTrials.gov ↗

Amendment history

2026-06-30
notable
Suspended→Recruiting Study Status, Contacts/Locations v6
Trial statusSuspended→Recruiting
Reason stoppedstudy drug issue→not stated
Start dateestimated 2026-07-15→confirmed 2026-06-28
Study sitesdetails revised at 1 of 1 site
2026-04-16
critical
Study Status v5
Primary completion pushed: 2026-12-31 → 2027-07-31
Start date2026-03-01→2026-07-15
2026-01-06
minor
Study Status v4
Start date2025-12-01→2026-03-01
2025-11-10
notable
Recruiting→Suspended Study Status, Contacts/Locations v3
Trial statusRecruiting→Suspended
Reason stoppednot stated→study drug issue
Start date2025-11-01→2025-12-01
Study sitesdetails revised at 1 of 1 site
2025-10-13
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2025-08-14
minor
Study Identification, Study Status, Contacts/Locations v1
Start date2025-07-01→2025-11-01
Study sitescontacts updated at 1 of 1 site
Study titlerevised
BZLF1 Peptide Vaccine (OSU-2131) withWith QS-21 for the Prevention of Epstein-Barr Virus Related Cancer in Patients Awaiting Solid Organ Transplants
2024-12-16
minor
Original filing
This phase 1B trial tests the safety, side effects and best dose of rh-Hsc70- BZLF1 peptide complex (OSU-2131) with Stimulon (Trademark) QS-21 and evaluates how well it works in preventing Epstein-Barr virus (EBV) infection and related cancers in healthy volunteers and patients awaiting a solid organ transplant. Currently, patients who receive an organ transplant receive immune suppression therapy which can make it harder for the body to fight infections. This treatment also increases the risk for cancers that are triggered by the EBV. Vaccines made from synthetic peptide (RAKFKQLL) derived from the BZLF1 protein, may help the body build an effective immune response against EBV infections. QS-21, a saponin adjuvant, is a substance from plants that, when given with vaccine therapy, may improve the way the immune system responds to disease. Giving OSU-2131 with QS-21 may help the immune system fight EBV and protect against EBV infection and the cancers that it can cause in patients awaiting solid organ transplants.
Trial Details
NCT Number NCT06741072
Lead Sponsor Ohio State University Comprehensive Cancer Center
Conditions Chronic Kidney Disease, Stage 4, Chronic Kidney Disease, Stage 5, EBV-Related Lymphoproliferative Disorder, EBV-Related Malignant Neoplasm, Post-Transplant Lymphoproliferative Disorder
Enrollment 55 participants
Start Date 2026-06-28
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-02