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.
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
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
Sequential
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Dulbecco''s Phosphate-Buffered Saline
DrugGiven SC
Peptide Vaccine
Biological/VaccineGiven OSU-2131 SC
QS21
Biological/VaccineGiven SC
Incidence of treatment-emergent adverse events
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 signs
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 signs
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 reactions
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.
Immune response
Will be defined as the change in pentamer RAK (RAKFKQLL) positive cells. The geometric mean of pentamer RAK positive cells will be reported at each time point with 95% confidence intervals, and the level of pentamer RAK positive cells will be plotted over time for each patient to visually identify changes in values from baseline through follow-up visits. BZLF1 HLA-B\*08:01 RAK pentamers and cytometry by time-of-flight will be used to test for an immune response.
Optimal immunologic dose (OID)
Percent CD3+, CD8+, RAK+ will be quantified for each patient. This will be completed for each dose level and following dose level 3 data analysis, a collective review of the flow cytometry will be performed to aid in determining the OID.
Click on the lead sponsor to view all of their trials.
