Peptide Vaccine for Cancer Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine designed to help the immune system combat the Epstein-Barr virus (EBV) and prevent related cancers. The trial combines a peptide derived from EBV with a plant-based adjuvant to enhance the body's immune response. It targets healthy volunteers and those awaiting an organ transplant, who face increased vulnerability to infections and EBV-related cancers due to immune suppression. Individuals awaiting a kidney transplant and undergoing regular dialysis may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.
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.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that the BZLF1 Peptide Vaccine (OSU-2131) with QS-21 is under study to determine its safety for people. This involves checking for side effects and identifying the correct dose. The vaccine includes a synthetic protein that aids the immune system in combating the Epstein-Barr virus (EBV), which is associated with certain cancers.
QS-21, a component of the vaccine, is a natural plant-derived substance that enhances the immune response. Although specific information on side effects from this vaccine is not yet available, it is important to note that phase 1 trials primarily focus on safety and are among the initial tests conducted in humans. This means the vaccine is still being evaluated for potential risks when administered to humans.
This testing stage is crucial for ensuring the vaccine's safety for further research and future use. Prospective trial participants can expect close monitoring by medical professionals for any side effects.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the BZLF1 Peptide Vaccine (OSU-2131) with QS-21 because it represents a novel approach to cancer prevention. Unlike traditional cancer treatments that target existing tumors, this vaccine aims to prevent cancer by stimulating the immune system to recognize and fight cancer cells before they develop into a full-blown disease. The use of the BZLF1 peptide as an active ingredient is particularly promising, as it is designed to specifically target antigens linked to cancer cell formation. This preventative strategy could potentially reduce the incidence of cancer, making it a groundbreaking addition to current cancer treatment options.
What evidence suggests that this peptide vaccine could be effective for preventing EBV-related cancers?
Research has shown that the BZLF1 Peptide Vaccine (OSU-2131) combined with QS-21 might help the immune system fight Epstein-Barr virus (EBV) infections. This vaccine contains a synthetic protein that aids the body in recognizing and combating EBV. QS-21, a natural plant-derived substance, enhances the immune response, potentially increasing the vaccine's effectiveness. This combination could theoretically prevent cancers linked to EBV, especially in individuals with weakened immune systems, such as those awaiting organ transplants. Although studies are ongoing, the vaccine appears promising in building protection against EBV-related conditions.12346
Who Is on the Research Team?
Timothy J. Voorhees, MD, MSCR
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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