Condition category
Cancer
Date applied
15/08/2016
Date assigned
22/09/2016
Last edited
24/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Public

Primary contact

Prof Yaohe Wang

ORCID ID

Contact details

Charterhouse Square
London
EC1M 6BQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16/LO/1512

Study information

Scientific title

Identification of immunogenic neo-epitopes for the development of personalised pancreatic cancer vaccines

Acronym

Study hypothesis

Sequence analysis has allowed us to develop a peptide library of neo-epitopes that are expressed at high frequency in patient populations and have high binding affinities compared to their wild-type counterpart to HLA-A2, HLA-DP4, HLA-E*01:01 or HLA-*01:03 molecules. We hypothesise that a number of these will be sufficiently immunogenic to stimulate a T cell interferon-γ (IFN-γ) response in vitro, that will translate to an in vivo anti-tumour response. Immunogenic neo-epitopes can then be combined in a peptide vaccination program using adjuvants such as oncolytic viruses for targeted delivery and expression within tumours of PDAC patients to stimulate robust and long-term anti-tumour responses.

Ethics approval

The Proportionate Review Sub-committee of the London - Westminster Research Ethics Committee, 10/08/2016, ref: 16/LO/1512

Study design

Observational

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available

Condition

Pancreatic cancer

Intervention

Peripheral blood mononuclear cells (PBMCs) obtained from leukocyte filters from healthy individuals will be HLA typed using commercially available reagents from thermofisher scientific. HLA-A2, HLA-DP4, HLA-E*01:01 and/or HLA-E*01:03 positive samples will be pulsed with peptides selected after bioinformatics analysis of available sequence data. IFN-γ and interleukin-2 (IL-2) production by the T cells in the samples will be evaluated by ELISA after two rounds of stimulation within a two weeks time as a measure of peptide immunogenicity. Once immunogenic peptides have been identified, their wild-type counterparts will be analysed in parallel to confirm specificity for the mutated epitope. Immunogenic peptides whose wild-type counterparts do not elicit immune responses will then be selected for inclusion in an oncolytic virus-based vaccine to be analysed in vivo using transgenic HLA-A2/HLA-DP4 mice.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Immunogenicity of neo-epitope candidates selected from available mutanome data using peripheral blood mononuclear cells (PBMCs) from healthy individuals.

Secondary outcome measures

N/A

Overall trial start date

01/08/2016

Overall trial end date

20/07/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Individuals who fulfill the NHS BT requirements for blood donation, which are:
1. fit and healthy
2. weigh over 7 stone 12 lbs or 50kg
3. are aged between 17 and 66 (or 70 if you have given blood before)
4. are over 70 and have given blood in the last two years

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

About 100 individuals.

Participant exclusion criteria

Same as NHS BT criteria, which are:
1. receiving treatment
2. taking medication
3. travelling outside of the UK
4. tattoos
5. pregnancy
6. illness
7. cancer
8. received blood, blood products or organs

Recruitment start date

01/08/2016

Recruitment end date

20/07/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Blood and Transplant. Blood Donation Centre Edgware
Edgware Community Hospital Burnt Oak Broadway Edgware
Middlesex
HA8 0AD
United Kingdom

Trial participating centre

NHS Blood and Transplant. Tooting Blood Donor Centre
75 Cranmer Street Tooting
London
SW17 0RB
United Kingdom

Sponsor information

Organisation

Joint Research Management Office, Queen Mary University of London

Sponsor details

5 Walden Street - Lower Ground Floor
London
E1 2EF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Pancreatic Cancer Research Fund

Alternative name(s)

PCRF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The results of this study will be published in suitable peer-reviewed scientific journals.

Intention to publish date

20/07/2019

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review.