BZLF1 Peptide Vaccine (OSU-2131) With QS-21 for the Prevention of Epstein-Barr Virus Related Cancer in Patients Awaiting Solid Organ Transplants
Eligible age
18–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Ohio State University Comprehensive Cancer Center
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Columbus
Source: ClinicalTrials.gov · NCT06741072 · last updated 2026-07-02