Peptide Vaccine for Cancer Prevention

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ohio State University Comprehensive Cancer Center

Must not be taking: Antivirals, Corticosteroids

Disqualifiers: Severe infection, Cardiopulmonary issues, Autoimmune, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: 9

Duration: 4 weeks

55 Participants Needed

What You Need to Know Before You Apply

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.

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 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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

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. ^{1 5 10 11 12}

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

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.

Exclusion Criteria

I have had chronic EBV infection or related conditions recently.

History of immune suppression or autoimmune disorder

Pregnant or breastfeeding subjects

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?

Group I: Group I (OSU-2131, QS-21) Experimental Treatment 3 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 Group 2 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial watch: Peptide-based vaccines in anticancer therapy. Bezu, L., Kepp, O., Cerrato, G., et al.[2021]

The combination of personalized peptide vaccination (PPV) and estramustine phosphate (EMP) was found to be safe for patients with castration-resistant prostate cancer (CRPC), with no serious treatment-related adverse events reported and only mild skin reactions observed.

The treatment successfully boosted immune responses in a significant portion of patients, with 67% showing enhanced cytotoxic T lymphocyte responses, and a median survival time of 23.8 months, suggesting promising antitumor activity that warrants further clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Noguchi, M., Uemura, H., Naito, S., et al.[2013]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccination with BLP25 liposome vaccine to treat non-small cell lung and prostate cancers. North, S., Butts, C.[2005]

Peptide-based vaccines targeting tumor-associated antigens (TAAs) in breast cancer have been under development for over 20 years, showing promise in eliciting specific immune responses without serious side effects in clinical trials.

Research has focused on enhancing vaccine efficacy by identifying more immunogenic peptides and optimizing combinations with adjuvants, which could lead to stronger immune responses and improved T-cell memory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peptide-based vaccination and induction of CD8+ T-cell responses against tumor antigens in breast cancer. Harao, M., Mittendorf, EA., Radvanyi, LG.[2020]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Trial Watch: Peptide vaccines in cancer therapy. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized phase I / II study of vascular endothelial growth factor receptor peptide vaccines for patients with hepatocellular carcinoma. [2023]

3. Japan pubmed.ncbi.nlm.nih.gov

[Clinical study of Peptide-cocktail vaccination with tegafur-uracil/leucovorin for advanced colorectal cancer]. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Trial watch: Peptide-based vaccines in anticancer therapy. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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]

6. England pubmed.ncbi.nlm.nih.gov

Vaccination with BLP25 liposome vaccine to treat non-small cell lung and prostate cancers. [2005]

7. England pubmed.ncbi.nlm.nih.gov

Phase I trial of OTS11101, an anti-angiogenic vaccine targeting vascular endothelial growth factor receptor 1 in solid tumor. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Peptide-based vaccination and induction of CD8+ T-cell responses against tumor antigens in breast cancer. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Generation of multiepitope cancer vaccines based on large combinatorial libraries of survivin-derived mutant epitopes. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Melanoma vaccine candidates from chimeric hepatitis B core virus-like particles carrying a tumor-associated MAGE-3 epitope. [2008]

11. United States pubmed.ncbi.nlm.nih.gov

Novel Cell-Penetrating Peptide-Based Vaccine Induces Robust CD4+ and CD8+ T Cell-Mediated Antitumor Immunity. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Vaccine Trials for the Clinician: Prospects for Tumor Antigens. [2019]