Peptide Vaccine for Cancer Prevention

Overseen by Timothy J. Voorhees, MD, MSCR

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Ohio State University Comprehensive Cancer Center

Stay on Your Current Meds

Trial Summary

What is the purpose of this trial?

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.

Research Team

Timothy J. Voorhees, MD, MSCR

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for healthy volunteers and patients awaiting a solid organ transplant who are at risk of Epstein-Barr virus (EBV) infection and related cancers. It's designed to test a vaccine aimed at preventing EBV-related conditions in those receiving immune suppression therapy post-transplant.

Inclusion Criteria

My Epstein-Barr virus status does not affect my eligibility.

Prothrombin time (PT) and partial thromboplastin time (PTT) below the upper limit of normal

I am of childbearing age and have a negative pregnancy test before starting the study drug.

Exclusion Criteria

I have had chronic EBV infection or related conditions recently.

History of immune suppression or autoimmune disorder

Pregnant or breastfeeding subjects

Treatment Details

Interventions

• BZLF1 Peptide Vaccine (OSU-2131) with QS-21 (Cancer Vaccine)

Trial Overview The trial tests the safety, side effects, and optimal dosage of an experimental peptide vaccine (OSU-2131) combined with QS-21, which may help build immunity against EBV infections potentially leading to cancer prevention in transplant recipients.

Participant Groups

Group I: Group I (OSU-2131, QS-21) Experimental Treatment 3 Interventions

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.

Group II: Group II (placebo) Placebo Group 2 Interventions

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.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Dr. David Cohn

Ohio State University Comprehensive Cancer Center

Interim Chief Executive Officer since 2022

MD, MBA

Dr. David Cohn

Ohio State University Comprehensive Cancer Center

Chief Medical Officer since 2018

MD