Identification of Immunogenic Neo-epitopes for the Development of Personalised Pancreatic Cancer Vaccines

NCT04379960 | Completed DMC

• 1 other identifier: 16/LO/1512
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

Human pancreatic cancer has a very poor prognosis with an overall survival rate of less than 5%. Current treatment regimens are ineffective and even if the patient responds to initial treatments, relapse is common due to the survival of small populations of resistant cancer cells. The immune system is capable of recognising and eliminating invading organisms by virtue of differences in their appearance when compared to normal components of the body. Cancer cells also have a different appearance compared to normal cells. However, these differences are often too small and weak to stimulate the immune system sufficiently to respond effectively to eliminate the tumour. Our aim is to analyse the small differences between healthy and cancer cells in pancreatic cancer patients. Analysis of the genetic information from 100 pancreatic cancer patients has allowed us to design molecules that display each of these small differences. We now intend to analyse each of these, with respect to their ability to stimulate an immune response against cancer. We then intend to take all validated molecules and incorporate them into vaccines carried by viral vectors. These vaccines can be used to train the patient's immune system to respond more effectively when it encounters these particular differences in the patient's body and thus mount an efficient attack on the cancer cells specifically. Surplus material from blood donations will be used to isolate individual components of the immune system, which can be examined for their response to these altered molecules in the laboratory. On completion of this project, we will have viral vaccine libraries that can be tested in future research projects. Ultimately, we hope to transfer this regime to the clinic by selecting an appropriate viral vaccine library to deliver as a personalised therapeutic that can eliminate cancer and prevent cancer recurrence within each patient.

Conditions

The Initial Aim of This Project is to Perform in Vitro Validation of Neoepitope Candidates Selected From Available Mutanome Data

Outcome Measures

Primary Outcomes (1)

• Develop Vaccinia virus and Adenovirus vaccine libraries expressing the identified immunogenic neo-epitopes.

  To perform in vitro validation of neo-epitope candidates selected from available mutanome data to determine their immunogenicity using peripheral blood mononuclear cells (PBMCs) from healthy individuals.

  1 month

Study Arms (2)

Peptides

PBMCs will be incubated with peptides.

Other: Peptides

W/o peptides

PBMCs will be incubated without peptides.

Other: Peptides

Interventions

Peptides OTHER

Peptides will be added to PBMCs in in vitro cell culture.

Peptides; W/o peptides

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy blood donors, who donate their blood at the Blood Donation Centres in London.

You may qualify if:

• fit and healthy;
• weigh over 7 stone 12 lbs or 50kg;
• are aged between 17 and 66 (or 70 if you have given blood before);
• are over 70 and have given blood in the last two years.

You may not qualify if:

• receiving treatment;
• taking medication;
• travelling outside of the UK;
• tattoos;
• pregnancy;
• illness;
• cancer;
• received blood, blood products or organs.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Barts Cancer Institute

London, EC1M 6BQ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Human blood from healthy donors, who donate blood at the Blood Donation Centres.

MeSH Terms

Interventions

Peptides

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: September 1, 2016
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: September 22, 2022

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)