Study on Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05078866

Provider View

This clinical trial is testing the safety and effects of the Nous-209 vaccine in people with Lynch syndrome, a genetic condition that increases the risk of colorectal and other cancers. The study aims to see if the vaccine can help the immune system recognize and fight cancer cells.

Patient Parameters

Program Overview

This study is exploring the safety and effectiveness of the Nous-209 vaccine in individuals with Lynch syndrome, a genetic disorder that raises the risk of developing colorectal cancer and other cancers. Lynch syndrome causes errors in genetic information, leading to the production of new proteins called neoantigens. These neoantigens are recognized by the immune system as foreign, prompting an immune response. The Nous-209 vaccine is made from synthetic versions of these neoantigens. The trial aims to determine if the vaccine is safe for Lynch syndrome patients, how well they tolerate it, and how their immune systems respond. Researchers also want to see if the vaccine affects the development of polyps or tumors in the colon.

Description

Primary Objectives:

  1. To assess the safety and tolerability of the Nous-209 vaccine, which includes two parts: the GAd-209-FSP priming vaccine and the MVA-209-FSP boosting vaccine, when given alone to people with Lynch syndrome.
  2. To evaluate how the immune system responds to the Nous-209 vaccine in people with Lynch syndrome.
  3. To study the immune response in those who have already been vaccinated and receive either the full vaccine series again or just the booster.
  4. To ensure the safety and tolerability of the vaccine in previously vaccinated individuals.

Secondary Objectives:

  1. To examine changes in immune cells in the blood after vaccination.
  2. To study the immune response in normal colon tissue after vaccination.
  3. To evaluate immune cells in colon polyps after vaccination.
  4. To test the ability of immune cells to attack cancer-like cells in the lab after vaccination.
  5. To assess the impact of the vaccine on the number of colon polyps or tumors.
  6. To evaluate the effect of the vaccine on cancers related to Lynch syndrome.
  7. To study changes in DNA in the blood after vaccination.
  8. To explore the relationship between smoking, alcohol use, and immune response to the vaccine.
  9. To assess genetic changes in polyps before and after the study.

Study Outline:

Part I: Participants receive the GAd20-209-FSP vaccine by injection on day 1 and the MVA-209-FSP vaccine at week 8. They will have endoscopies with biopsies and provide blood samples.

Part II: Eligible participants from Part I are randomly assigned to one of two groups:

  • Arm A: Receive the GAd20-209-FSP vaccine at week 52 and the MVA-209-FSP vaccine at week 60, with endoscopies and blood samples.
  • Arm B: Receive the MVA-209-FSP vaccine at week 52, with endoscopies and blood samples.

After treatment, participants are followed up at weeks 16, 24, 36, and 52.

Eligibility Criteria

Inclusion Criteria

  • Must have Lynch syndrome, confirmed by genetic testing or family history.
  • No active or returning cancer for at least 6 months before the study.
  • At least 6 months since any cancer treatment like surgery, chemotherapy, or radiation.
  • Must have part of the colon or rectum intact for endoscopy.
  • Agree to regular colonoscopies with biopsies every 12 months.
  • Agree not to use certain pain relievers during the study, except low-dose aspirin.
  • Age 18 or older.
  • Good overall health with specific blood test results.
  • Agree not to receive other vaccines during the study.
  • Agree to use birth control during the study and for 6 months after.
  • Able to understand and sign a consent form.

For Cohort 2:

  • Must have completed Part I of the study and shown an immune response.
  • Agree not to receive other vaccines during specific weeks of the study.
  • Agree to a pregnancy test at week 52 if female.

Exclusion Criteria

  • Received certain vaccines, including COVID-19 adenovirus vaccines, in the past 6 months.
  • Have high-grade dysplasia or cancer at screening.
  • Have active cancer (except non-melanoma skin cancer).
  • Have serious uncontrolled medical or psychiatric conditions.
  • Have active infections like HIV, hepatitis B, or hepatitis C.
  • Have a history of organ transplant or immune deficiency.
  • Have allergies to study drugs or related substances.
  • Require high-dose steroids or immunosuppressive drugs.
  • Pregnant, breastfeeding, or planning to become pregnant within 6 months after the study.
  • Men planning to father children during or shortly after the study.
  • Participating in other clinical trials.
  • For Cohort 2: Experienced severe side effects from the study drug in Part I.

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