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Prevention study for Chronic Kidney Disease, Stage 4
Official title BZLF1 Peptide Vaccine (OSU-2131) With QS-21 for the Prevention of Epstein-Barr Virus Related Cancer in Patients Awaiting Solid Organ Transplants
ClinicalTrials.gov ID: NCT06741072
What this study is testing
What is Dulbecco''s Phosphate-Buffered Saline?
Dulbecco''s Phosphate-Buffered Saline is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic kidney disease, stage 4.
Also referred to as DPBS, PBS.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Healthy volunteers and patients awaiting solid organ transplantation (SOT) must have at least one allele for HLA-B\ 08:01
- people can be Epstein-Barr virus (EBV) seronegative or seropositive
- people must be seronegative for HIV
- people must be seronegative for hepatitis B and C
- Have baseline chemistry and hematology (hemoglobin, white blood cells, absolute neutrophil count, eosinophils) within normal limits
You likely can't join if
- Severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the principal investigator...
- History of chronic active EBV infection, active infectious mononucleosis (or infectious mononucleosis within 6 months of enrollment), or other...
- 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...
- Pregnant or breastfeeding people
- For patient enrollment on the second cohort, "patients awaiting SOT", we will consider patients awaiting kidney transplantation who are receiving...
See the full eligibility criteria
- Healthy volunteers and patients awaiting solid organ transplantation (SOT) must have at least one allele for HLA-B\ 08:01
- people can be Epstein-Barr virus (EBV) seronegative or seropositive
- people must be seronegative for HIV
- people 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...
- people 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...
- 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 people
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.