Peptide Vaccine for Cancer Prevention
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants do not take antiviral therapy and avoid systemic corticosteroids or other immunosuppressive medications, except for nasal steroids for seasonal allergies.
What data supports the effectiveness of the BZLF1 Peptide Vaccine (OSU-2131) with QS-21 treatment for cancer prevention?
Peptide-based vaccines, like the BZLF1 Peptide Vaccine, aim to stimulate the immune system to fight cancer. Although these vaccines have shown limited success due to challenges like cancer cells avoiding detection, combining them with other treatments or using immune-boosting substances has shown promise in improving their effectiveness.12345
Is the BZLF1 Peptide Vaccine (OSU-2131) with QS-21 safe for humans?
How is the BZLF1 Peptide Vaccine (OSU-2131) with QS-21 treatment different from other cancer treatments?
The BZLF1 Peptide Vaccine (OSU-2131) with QS-21 is unique because it uses a peptide-based approach to stimulate the immune system to recognize and attack cancer cells, potentially offering a more targeted and less toxic alternative to traditional cancer treatments. This vaccine aims to induce a strong immune response by presenting specific cancer-related peptides to the immune system, which is different from conventional therapies that often involve chemotherapy or radiation.69101112
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive OSU-2131 with QS-21 or placebo subcutaneously on day 0, and weeks 2 and 4
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BZLF1 Peptide Vaccine (OSU-2131) with QS-21
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor