NCT06741072

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

A Phase 1B Double Blinded Randomized Trial Evaluating Safety, Tolerability, and Immune Response of OSU-2131 a BZLF1 Peptide Vaccine With Stimulon™ QS-21 Solution Adjuvant in Healthy Volunteers and Patients Awaiting Solid Organ Transplantation

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. Determine the overall safety profile of three different dose levels of OSU-2131 vaccination each with 50 mcg Stimulon (Trademark) Quillaja saponin (QS)-21 Solution adjuvant (QS-21), wherein the OSU-2131 doses are 80, 240 and 480 mcg in healthy volunteers and similar safety profile of the identified maximum tolerated dose (MTD) in patients awaiting solid organ transplantation. SECONDARY OBJECTIVES: I. Determine the optimal immunologic dose (OID) to OSU-2131 vaccination (with QS-21) in all dose cohorts of 80, 240, and 480 mcg OSU-2131 (healthy volunteers) and, upon completing safety assessment, patients awaiting solid organ transplant (PASOT). II. To perform laboratory correlative studies to examine immune responses to the OSU-2131 vaccine with the intent to communicate the research results and to generate a de-identified data set that can then be used for future comparisons with immune response data generated in future vaccine trials. OUTLINE: This is a dose-escalation study of OSU-2131 with fixed-dose QS-21 followed by a dose-expansion study. Healthy volunteers are randomized to 1 of 2 groups. Patients awaiting a solid organ transplant are assigned to Group I. GROUP I (OSU-2131 WITH QS-21): Healthy volunteers and patients receive OSU-2131 subcutaneously (SC) with QS-21 SC on day 0, and weeks 2 and 4 in the absence of unacceptable toxicity or patient proceeds to transplant. Healthy volunteers and patients additionally undergo blood sample collection throughout the study. GROUP II (PLACEBO): Healthy volunteers receive Dulbecco's phosphate-buffered saline (phosphate buffered saline \[PBS\]) SC on day 0, and weeks 2 and 4 in the absence of unacceptable toxicity. Healthy volunteers additionally undergo blood sample collection throughout the study. After completion of study intervention, healthy volunteers and patients are followed up at days 29 and 35 and then at 6, 16, 28, 40 and 56 weeks.

Conditions

• Chronic Kidney Disease, Stage 4
• Chronic Kidney Disease, Stage 5
• EBV-Related Lymphoproliferative Disorder
• EBV-Related Malignant Neoplasm
• Post-Transplant Lymphoproliferative Disorder

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
DRUG	Dulbecco''s Phosphate-Buffered Saline	Given SC
BIOLOGICAL	Peptide Vaccine	Given OSU-2131 SC
BIOLOGICAL	QS21	Given SC

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-12-18
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study