Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients
NCT05078866 · View on ClinicalTrials.gov ↗
Study Summary
This phase Ib/II trial evaluates the safety and effect of the Nous-209 vaccine in Lynch syndrome patients. Lynch syndrome is an inherited disorder in which affected individuals have a higher-than-normal chance of developing colorectal cancer and certain other types of cancer, often before the age of 50. In Lynch syndrome, errors in the genetic information inside cells are not properly corrected. When that happens, the cells produce new proteins called neoantigens. Neoantigens are recognized by the body's immune system as foreign, and the body tries to get rid of them. Nous-209 is a vaccine made with man-made copies of some of those neoantigens. This trial aims to see whether the Nous-209 vaccine is safe to give to patients with Lynch syndrome, whether people are able to take the Nous-209 vaccine without becoming too uncomfortable, and how the immune system of patients with Lynch syndrome respond to the Nous-209 vaccine. This trial may help researchers determine whether receiving Nous-209 have an effect on the development of polyps or tumors in the colon.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
- PROCEDURE Endoscopic Biopsy
- BIOLOGICAL Adenoviral Tumor-specific Neoantigen Priming Vaccine GAd-209-FSP
- BIOLOGICAL MVA Tumor-specific Neoantigen Boosting Vaccine MVA-209-FSP
Study Locations (4)
California
- City of Hope Comprehensive Cancer Center — Duarte
Pennsylvania
- Fox Chase Cancer Center — Philadelphia
Texas
- M D Anderson Cancer Center — Houston
Other
- University of Puerto Rico — San Juan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2022-11-10 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05078866
The ClinicalTrials.gov registry entry for NCT05078866 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Colorectal Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05078866 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Pennsylvania, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05078866 about?
NCT05078866 is a clinical study titled "Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients". This phase Ib/II trial evaluates the safety and effect of the Nous-209 vaccine in Lynch syndrome patients. Lynch syndrome is an inherited disorder in which affected individuals have a higher-than-normal chance of developing colorectal cancer and certain other types of cancer, often before the age of...
What is the current status of trial NCT05078866?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2022-11-10. Estimated completion is 2026-09-30.
What conditions does trial NCT05078866 study?
This clinical trial studies the following conditions: Colorectal Carcinoma, Lynch Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05078866?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Endoscopic Biopsy (PROCEDURE), Adenoviral Tumor-specific Neoantigen Priming Vaccine GAd-209-FSP (BIOLOGICAL), MVA Tumor-specific Neoantigen Boosting Vaccine MVA-209-FSP (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05078866?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05078866 being conducted?
This trial has 4 study locations across California, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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