Peptide Vaccine for Cancer Prevention

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Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Ohio State University Comprehensive Cancer Center
Stay on Your Current MedsYou can continue your current medications while participating

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.12345

Why 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 VOORHEES | Assistant Professor ...

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

Prothrombin time (PT) and partial thromboplastin time (PTT) below the upper limit of normal
My Epstein-Barr virus status does not affect my eligibility.
I am of childbearing age and have a negative pregnancy test before starting the study drug.
See 11 more

Exclusion Criteria

I have had chronic EBV infection or related conditions recently.
History of immune suppression or autoimmune disorder
Pregnant or breastfeeding subjects
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive OSU-2131 with QS-21 or placebo subcutaneously on day 0, and weeks 2 and 4

4 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks
6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • BZLF1 Peptide Vaccine (OSU-2131) with QS-21
Trial Overview The trial tests the safety, side effects, and optimal dosage of an experimental peptide vaccine (OSU-2131) combined with QS-21, which may help build immunity against EBV infections potentially leading to cancer prevention in transplant recipients.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group I (OSU-2131, QS-21)Experimental Treatment3 Interventions
Group II: Group II (placebo)Placebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

Published Research Related to This Trial

The VEGFR-targeted peptide vaccines were safe for patients with unresectable hepatocellular carcinoma (HCC), with no severe adverse events reported during the study involving 22 patients.
The vaccines successfully induced specific immune responses in a majority of patients, leading to improved progression-free survival (PFS) in those with strong immune responses, although overall survival rates did not show statistically significant differences compared to the placebo group.
A randomized phase I / II study of vascular endothelial growth factor receptor peptide vaccines for patients with hepatocellular carcinoma.Yoshimaru, Y., Nagaoka, K., Tanaka, K., et al.[2023]
The BLP25 liposome (L-BLP25) cancer vaccine targets the MUC1 tumor-associated antigen and has shown potential to extend survival in patients with advanced-stage non-small cell lung cancer, while also maintaining their quality of life.
L-BLP25 may also benefit prostate cancer patients by prolonging prostate-specific antigen doubling time in those experiencing biochemical failure after surgery, indicating its promise as a relatively nontoxic therapeutic option.
Vaccination with BLP25 liposome vaccine to treat non-small cell lung and prostate cancers.North, S., Butts, C.[2005]
A clinical trial using vaccines targeting specific cancer peptides (RNF43 and TOMM34) in combination with tegafur-uracil/Leucovorin (UFT/LV) for advanced colorectal cancer showed good tolerance and no adverse events.
Patients who developed cytolytic T-lymphocyte (CTL) responses to both RNF43 and TOMM34 had the highest long-term survival rates, indicating the potential effectiveness of these targeted vaccines in cancer treatment.
[Clinical study of Peptide-cocktail vaccination with tegafur-uracil/leucovorin for advanced colorectal cancer].Sugiura, F., Inoue, K., Okuno, K., et al.[2020]

Citations

NCT06741072 | BZLF1 Peptide Vaccine (OSU-2131) With ...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 ...
BZLF1 Peptide Vaccine (OSU-2131) with QS-21 for the ...This phase IB trial tests the safety, side effects and best dose of rh-Hsc70- BZLF1 peptide complex (OSU-2131) with Stimulon (Trademark) QS-21 and evaluates ...
BZLF1 Peptide Vaccine (OSU-2131) With QS- ...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 ...
Peptide Vaccine for Cancer PreventionThis 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 ...
BZLF1 Peptide Vaccine (OSU-2131) With QS-21 for the ...A Study to Evaluate the Safety and Effectiveness of a Vaccine to Prevent Epstein-Barr Virus-Related Cancer in Patients Awaiting Solid Organ Transplants.
BZLF1 Peptide Vaccine (OSU-2131) With QS-21 for the ...Descriptive statistics, per treatment arm, will contain the number and percentage of subjects who experience at least one adverse event (AE), AE related to ...
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