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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jun 28, 2026

Status verified

Jun 2026

Primary completion

Jul 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

55 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Arms

• Experimental: Group I (OSU-2131, QS-21)
  Healthy volunteers and patients receive OSU-2131 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.
• Placebo Comparator: Group II (placebo)
  Healthy volunteers receive 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.

Primary Outcome Measure

Incidence of treatment-emergent adverse events [ Time Frame: From the first administration of treatment until the week 28 visit ]

Central Contacts

• The Ohio State University Comprehensive Cancer Center
  800-293-5066
  [email protected]

Locations (1)

Find similar trials in Columbus, OH

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