55 Participants Needed

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

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?

Clinical studies on peptide vaccines for cancer, including those for breast and prostate cancer, have generally found no serious side effects, suggesting they are safe for human use.25678

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 VOORHEES | Assistant Professor ...

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

My Epstein-Barr virus status does not affect my eligibility.
Prothrombin time (PT) and partial thromboplastin time (PTT) below the upper limit of normal
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

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group I (OSU-2131, QS-21)Experimental Treatment3 Interventions
Healthy volunteers and patients receive OSU-2131 SC with QS-21 SC on day 0, and weeks 2 and 4 in the absence of unacceptable toxicity or patient proceeds to transplant. Healthy volunteers and patients additionally undergo blood sample collection throughout the study.
Group II: Group II (placebo)Placebo Group2 Interventions
Healthy volunteers receive PBS SC on day 0, and weeks 2 and 4 in the absence of unacceptable toxicity. Healthy volunteers additionally undergo blood sample collection throughout the study.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

Findings from Research

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]
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]
Peptide-based anticancer vaccines have shown limited effectiveness in clinical settings due to cancer cells' ability to reduce antigen visibility and the immunosuppressive nature of the tumor environment.
To enhance their therapeutic potential, strategies such as using immunostimulatory adjuvants, combining with cytotoxic therapies, and blocking immune checkpoints are being explored, along with personalized peptide vaccines tailored to individual patients.
Trial watch: Peptide-based vaccines in anticancer therapy.Bezu, L., Kepp, O., Cerrato, G., et al.[2021]

References

Trial Watch: Peptide vaccines in cancer therapy. [2021]
A randomized phase I / II study of vascular endothelial growth factor receptor peptide vaccines for patients with hepatocellular carcinoma. [2023]
[Clinical study of Peptide-cocktail vaccination with tegafur-uracil/leucovorin for advanced colorectal cancer]. [2020]
Trial watch: Peptide-based vaccines in anticancer therapy. [2021]
A phase I study of personalized peptide vaccination using 14 kinds of vaccine in combination with low-dose estramustine in HLA-A24-positive patients with castration-resistant prostate cancer. [2013]
Vaccination with BLP25 liposome vaccine to treat non-small cell lung and prostate cancers. [2005]
Phase I trial of OTS11101, an anti-angiogenic vaccine targeting vascular endothelial growth factor receptor 1 in solid tumor. [2021]
Peptide-based vaccination and induction of CD8+ T-cell responses against tumor antigens in breast cancer. [2020]
Generation of multiepitope cancer vaccines based on large combinatorial libraries of survivin-derived mutant epitopes. [2023]
Melanoma vaccine candidates from chimeric hepatitis B core virus-like particles carrying a tumor-associated MAGE-3 epitope. [2008]
11.United Statespubmed.ncbi.nlm.nih.gov
Novel Cell-Penetrating Peptide-Based Vaccine Induces Robust CD4+ and CD8+ T Cell-Mediated Antitumor Immunity. [2021]
Vaccine Trials for the Clinician: Prospects for Tumor Antigens. [2019]
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