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BZLF1 Peptide Vaccine for Preventing EBV-Related Cancers in Transplant Patients

This study is testing a vaccine called OSU-2131 along with QS-21 to see if it can prevent cancers linked to the Epstein-Barr virus (EBV) in people waiting for organ transplants and in healthy volunteers. Patients who receive organ transplants often take medicines that weaken their immune system, which can increase their risk for EBV infections and related cancers. This vaccine aims to help your body build a strong immune response against EBV. The study will look at the safety and side effects of OSU-2131 and QS-21, and how well it helps the immune system. We are currently unclear on the status of this study, which plans to enroll 55 participants.

Study design
This is a dose-escalation study, meaning different doses of the vaccine will be tested. It involves both healthy volunteers and patients awaiting solid organ transplantation.
What's involved
You would have blood samples collected and receive injections of the study drugs. Vital signs will be monitored at baseline and for up to 56 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your vital signs and laboratory parameters will be monitored for up to 56 weeks after the start of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06741072

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

Recruiting
PHASE1Ages 18–65InterventionalPrevention
Ohio State University Comprehensive Cancer Center
~55 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Biospecimen CollectionDulbecco''s Phosphate-Buffered SalinePeptide VaccineQS21

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-emergent adverse events
Measured over From the first administration of treatment until the week 28 visit
+3 more outcomes measured

Conditions

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

Explore related trials

Chronic Kidney DiseaseHLA-B Gene

NCT06741072

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Timothy J Voorhees, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Eligibility criteria

Inclusion

Healthy volunteers and patients awaiting solid organ transplantation (SOT) must have at least one allele for HLA-B\*08:01
Subjects can be Epstein-Barr virus (EBV) seronegative or seropositive
Subjects must be seronegative for HIV
Subjects must be seronegative for hepatitis B and C
Have baseline chemistry and hematology (hemoglobin, white blood cells, absolute neutrophil count, eosinophils) within normal limits
Prothrombin time (PT) and partial thromboplastin time (PTT) below the upper limit of normal
Platelets above the lower limit of normal (LLN)
Basophils, lymphocytes, and monocytes must be within 1.2 x upper limit of normal (ULN) or 0.8 x LLN and considered not clinically significant by the investigator
Total creatine kinase (CK) laboratory values \< 1.25 x the upper limit of normal (according to the normal reference ranges of the Ohio State University \[OSU\] laboratory) at baseline (screening \& pre-study visit) and considered not clinically significant by the investigator
Subjects must not be taking antiviral therapy
Must be ≥ 18 years of age and ≤ 65 years of age and willing to either use an effective method of contraception or abstain from sexual activity for at least 3 months following the last dose of vaccination
Female of childbearing potential must have a negative serum pregnancy test prior to the first study drug/placebo (PBS) administration
Agree not to receive any other investigational drug while enrolled in this study
Provide written informed consent according to International Conference on Harmonization-Good Clinical Practice (ICH-GCP) and local regulations
Following successful completion of safety evaluation for the phase 1 dose escalation phase of this trial in healthy volunteers and review of this data by the Sponsor and Food and Drug Administration (FDA), we plan to enroll a second cohort of patients awaiting solid organ transplantation (SOT). We will recruit patients with end stage renal disease (ESRD) who are awaiting kidney transplantation. ESRD is defined according to 2012 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease (Acosta-Ochoa et al, J Clin Med, 8(9):1323, 2019). KDIGO defines ESRD as: stage 4: severe reduction in glomerular filtration rate (GFR) (15 to 29 mL/min); stage 5: renal failure (GFR less than 15 mL/min). Patients will qualify for ESRD / kidney transplantation per need for maintenance dialysis due to one or more of the criteria related to renal insufficiency: volume overload, metabolic acidosis, electrolyte disturbance, drug toxicity, etc. Patients will be regularly undergoing hemodialysis or peritoneal dialysis for metabolic support. Patients will be excluded from the study if they have any unstable medical conditions which the investigator believes would preclude participation in the study. These conditions include but are not limited to cardiorenal and hepatorenal syndromes

Exclusion

Severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the principal investigator, would prevent study completion
History of chronic active EBV infection, active infectious mononucleosis (or infectious mononucleosis within 6 months of enrollment), or other EBV-related disorder as determined by principal investigator (PI)
History of immune suppression or autoimmune disorder
Concomitant use of systemic corticosteroids or other immunosuppressive medications (including nasal and inhaled steroids). The use of nasal steroids for seasonal rhinitis is acceptable
Pregnant or breastfeeding subjects
For patient enrollment on the second cohort, "patients awaiting SOT", we will consider patients awaiting kidney transplantation who are receiving maintenance renal replacement therapy (dialysis). Most patients on routine renal replacement therapy (dialysis) will present with stable chemistry, acid base balance, volume status and clear mental status. For patients who are non-compliant with routine dialysis, laboratory abnormalities and acid base, volume status can become abnormal. Specific dose limiting toxicity (DLT) criteria that may relate to patients with ESRD include laboratory parameters that may altered due to missed dialysis session(s). Most laboratory abnormalities in such patients can be corrected by restarting dialysis or blood transfusions. Outside these specific variables, we do not expect to see specific DLT criteria for patients with ESRD on this study. Metabolic derangement such as acid base imbalance, hyperkalemia and volume overload as a result of missing dialysis session. Study stopping rule for subjects awaiting organ transplant: Occurrence of this event in two or more subjects should result in study pause. Patients who are unable to adhere to routine dialysis will be excluded from the study if they have any unstable medical conditions which the investigator believes would preclude participation in the study. These conditions include but are not limited to cardiorenal and hepatorenal syndromes

What this trial measures

  • Incidence of treatment-emergent adverse eventsFrom the first administration of treatment until the week 28 visit

    Will be coded to body systems and preferred terms using the Medical Dictionary for Regulatory Activities. Descriptive statistics, per treatment arm, will contain the number and percentage of subjects who experience at least one adverse event (AE), AE related to study treatment, serious AE, serious AE related to study treatment, grade 3 or 4 AE, and grade 3 or 4 related to study treatment. The number and percentage of subjects who discontinue treatment due to an AE will be provided, together with the number and percentage of subjects who die due to an AE.

  • Changes in laboratory parameters and vital signsAt baseline and up to week 56

    Changes will be summarized for subjects in each treatment arm. Baseline laboratory values will be summarized. The number and percentage of subjects with values below, within, and above normal range for each lab parameter will be summarized. Clinically significant abnormalities noted by the clinician during laboratory evaluations will be summarized by treatment arm.

  • Pre- and post-injection vital signsUp to week 4

    The number and percent of subjects who experience a clinically significant change in vitals from pre-injection to post-injection will be tabulated and summarized by treatment arm.

  • Injection site reactionsAt 10 and/or 60 minutes post injection on weeks 0, 2 and 4

    The number and percent of subjects who experience induration at 10 minutes post injection and/or 60 minutes post injection will be tabulated and summarized by treatment arm. The number and percent of subjects who experience erythema at 10 minutes post injection and/or 60 minutes post injection will be tabulated and summarized by treatment arm.