NHS Cancer Vaccine Launch Pad (NHS CVLP)
| ISRCTN | ISRCTN13053675 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13053675 |
| Integrated Research Application System (IRAS) | 325291 |
| Central Portfolio Management System (CPMS) | 57835 |
| Sponsor | NHS England |
| Funder | NHS England as sponsor will be receiving funding from multiple industry companies |
- Submission date
- 09/07/2024
- Registration date
- 09/10/2024
- Last edited
- 10/04/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Personalised cancer vaccines are a type of cancer treatment designed to target an individual’s unique cancer cells. They are created by analysing a patient’s tumour and identifying specific DNA changes that are unique to that cancer, then using that information to create a vaccine tailored to that patient. The intention is that the cancer vaccine will stimulate the immune system to specifically recognise and destroy the cancer cells. Immunotherapies are types of cancer treatment designed to help the body's immune system identify and attack cancer cells by focusing on specific features found on or within cancer cells that make them distinctly different from healthy cells.
The NHS Cancer Vaccine Launch Pad (CVLP) is looking to find people who may be able to take part in research trials for personalised vaccines or immunotherapies to treat cancer. By supporting these trials, the CVLP aims to speed up the development of personalised treatments for cancer patients.
Who can participate?
NHS cancer patients in England aged over 16 years with the capacity to consent.
What does the study involve?
Upon consent, the following will occur:
1. Small sections of the tumor will be cut from the diagnostic block by a histopathologist (a doctor who specializes in studying tissues). These sections will be sent to CVLP partners for nucleic acid extraction and sequencing. Nucleic acids are molecules like DNA and RNA that carry genetic information.
2. A blood sample, up to 30 milliliters, will be drawn and sent to CVLP partners. This sample may be tested for germline nucleic acid (genetic information you were born with) and tumor circulating free DNA (genetic material released by the tumor into the bloodstream).
3. Baseline demographic (like age and gender) and clinical data will be recorded by the clinical or research team and sent with the biological material in a pseudonymised form (using codes instead of names to protect your identity). This data will also be centrally held by Southampton Clinical Trials Unit (SCTU) to coordinate with cancer vaccine trial partners and sites. A clinical liaison team will oversee this process.
4. During Phase 1, sequencing data will be held by industry partners. If you are eligible for a cancer vaccine trial, the clinical liaison team will inform your clinical team and local trial sites. Pseudonymised codes will be used to identify patients when communicating with clinical teams or linking patients with NHS cancer vaccine trial sites. Any other information shared outside the NHS CVLP framework will also be pseudonymised.
5. If you are eligible for a cancer vaccine trial, your home clinical or research team, or the team at the nearest cancer vaccine trial site, will approach you for further discussion and a separate consent.
What are the possible benefits and risks of participating?
By taking part in the CVLP, participants might be able to take part in a research trial and receive personalised cancer vaccine treatment before it is widely available. For participants who receive this personalised treatment, it may reduce the chance of their cancer growing or coming back.
Not everyone will be suitable to take part in a research trial and the research trial may not benefit all participants directly. This is because we are still finding out how effective the treatment might be.
Participants can also benefit from the knowledge that they are helping medical research to improve cancer treatment. The tests and treatments being used were developed with the help of participants who took part in research years ago. The more participants that take part in research, the faster progress can be made as more human samples can be studied.
Where is the study run from?
The study is coordinated by the Southampton Clinical Trials Unit and is being run in NHS hospitals in England. The study is sponsored by NHS England.
When is the study starting and how long is it expected to run for?
May 2023 to December 2030
Who is funding the study?
NHS England (UK)
Who is the main contact?
Southampton Clinical Trials Unit at cvlp@soton.ac.uk
Contact information
Scientific
Southampton Clinical Trials Unit, Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
| Phone | +44 2381205154 |
|---|---|
| cvlp@soton.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Participant information sheet | 45760 NHSE CVLP Participant Information Sheet v8 22Mar2024.pdf |
| Scientific title | Establishing a UK platform to collect tumour samples and perform DNA/RNA sequencing for the development of personalised cancer vaccines and immunotherapies |
| Study acronym | CVLP |
| Study objectives | The objectives of the NHS Cancer Vaccine Launch Pad (CVLP) are to: 1. Identify cancer patients undergoing resection or biopsy of their tumours who could be eligible for personalised mRNA therapies such as cancer vaccines. 2. Create a pathway for collection and transfer of tumour samples, blood samples and pseudonymised clinical data during routine NHS care. 3. Send samples for DNA extraction, molecular analysis and sequencing initially in partnership with industry (Phase 1) and later to be performed by the NHS Genomic Medicine Service (Phase 2). 4. Use the results to accelerate access of eligible cancer patients to cancer vaccine trials. The programme aims to profile up to 10,000 tumour samples in a phased approach over 7 years. To achieve this we will enrol patients diagnosed with different cancers and seek their consent for: 1. Collection of surplus tumour biopsies or surgical resection samples to be sent to genetic testing laboratories for DNA or RNA extraction and sequencing. 2. Collection of a blood sample to perform relevant tests for cancer vaccines, eg: circulating free tumour DNA or sequencing of healthy cells to compare to the tumour. 3. Collection of routine clinical data on demographics, staging, diagnostic tests, treatment and outcomes. 4. The linkage of this data in a database held by a central team to co-ordinate between clinical sites, industry partners and cancer vaccine trial sites. 5. Onwards referral of potentially eligible patients to CV trials or linked research studies provided relevant research ethics approval has been granted - for which separate consent will be sought. No specific therapeutic intervention will be carried out under this protocol and any activities for the CVLP will happen in addition to routine genetic testing that is carried out as standard of care. If CV gain regulatory approval we hope the CVLP pathway will become part of routine care. |
| Ethics approval(s) |
Approved 20/08/2023, East of England – Essex Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8177; essex.rec@hra.nhs.uk), ref: 23/EE/0178 |
| Health condition(s) or problem(s) studied | Immunotherapy and cancer vaccine studies in various cancer types |
| Intervention | Eligible patients with a number of different cancers will be approached around the time of diagnostic biopsy or surgical resection. This could be either during their initial diagnosis of cancer or at the time of recurrence. In all cases the patient will be aware that a diagnosis of cancer has already been made, or is a strong possibility. The patient will be approached by the clinical team managing their care to discuss the study and a standard patient information sheet will be provided. Patients who agree to take part will have their informed consent confirmed and recorded by one of the clinical team or a research associate. Following consent, the following will occur: 1. Cuttings of sections of tumour from the diagnostic block under the supervision of a histopathologist, for forwarding to CVLP partners (Phase 1) for extraction and sequencing of nucleic acid. 2. Drawing of a blood sample (up to 30mls) also for forwarding to CVLP partners. Potential tests performed on blood samples include germline extraction of nucleic acid for the comparison with the tumour sample or tumour circulating free tumour DNA. 3. Recording of baseline demographic and clinical data will be done by the clinical or research team. This will be sent along with biological material in a pseudonymised form. Data will be held centrally by the Southampton Clinical Trials Unit (SCTU). 4. During Phase 1 sequencing data will be held by industry partners. If a patient is deemed to be eligible for a cancer vaccine trial this will be fed back to the clinical liaison team who will inform the clinical teams and any local trial sites. The pseudonymised codes will only be used for re-identifying patients when communicating with the clinical team or to link patients with NHS cancer vaccine trial sites. Any other information shared outside the NHS CVLP framework will be pseudonymised. 5. If a patient is deemed eligible for a cancer vaccine trial they will be approached by either their home clinical or research team, or by the team at the nearest cancer vaccine trial site for further discussion and a separate consent. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Number of participants recruited to the CVLP by September 2024 |
| Key secondary outcome measure(s) |
Number of sequencing outputs from NHS laboratories used for manufacturing of therapeutic personalised cancer vaccines measured every 12 months until study closure |
| Completion date | 31/12/2030 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 110 Years |
| Sex | All |
| Target sample size at registration | 10000 |
| Key inclusion criteria | 1. Be over the age of 16 years 2. Have a tumour which has been, or will be resected or biopsied 3. Have the capacity to consent to involvement in the CVLP 4. Have sufficient tumour available for genomic analyses |
| Key exclusion criteria | 1. Under the age of 16 years 2. Incapable of giving informed consent |
| Date of first enrolment | 31/08/2024 |
| Date of final enrolment | 31/03/2028 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Hermitage Lane
Maidstone
ME16 9QQ
England
Tonbridge Road
Pembury
Tunbridge Wells
TN2 4QJ
England
Tremona Road
Southampton
SO16 6YD
England
London
SE13 6LH
England
Woolwich
London
SE18 4QH
England
Guildford
GU2 7XX
England
Brighton
BN2 5BE
England
St. Leonards-on-sea
TN37 7RD
England
Eastbourne
BN21 2UD
England
Hills Road
Cambridge
CB2 0QQ
England
Romford
RM7 0AG
England
Charter Way
Turner Road
Colchester
CO4 5JL
England
Ipswich
IP4 5PD
England
Aylesbury
HP21 8AL
England
High Wycombe
HP11 2TT
England
Pield Heath Road
Uxbridge
UB8 3NN
England
Old Road
Headington
Oxford
OX3 7LE
England
Nottingham
NG7 2UH
England
Nottingham
NG5 1PB
England
Warwick
CV34 5BW
England
Heath Town
Wolverhampton
WV10 0QP
England
Walsall
WS2 9PS
England
Stoke-on-trent
ST4 6QG
England
Eccles
Salford
M6 8HD
England
Oldham
OL1 2JH
England
Rochdale Old Road
Bury
BL9 7TD
England
Rochdale
OL12 0NB
England
Leeds
LS9 7TF
England
Leeds
LS1 3EX
England
Sheffield
S10 2SJ
England
Derriford
Plymouth
PL6 8DH
England
Taunton
TA1 5DA
England
Yeovil
BA21 4AT
England
Barrack Road
Exeter
EX2 5DW
England
Barnstaple
EX31 4JB
England
Bristol
BS2 8ED
England
Westbury-on-trym
Bristol
BS10 5NB
England
Bath
BA1 3NG
England
Cheltenham
GL53 7AN
England
Gloucester
GL1 3NN
England
Lancaster
LA1 4RP
England
Blackburn
BB2 3HH
England
Carlisle
CA2 7HY
England
Hensingham
Whitehaven
CA28 8JG
England
Sunderland
SR4 7TP
England
South Shields
NE34 0PL
England
Middlesbrough
TS4 3BW
England
North Shields
NE29 8NH
England
Court Road
Chelmsford
CM1 7ET
England
Basildon
SS16 5NL
England
Westcliff-on-sea
SS0 0RY
England
Bournemouth
BH7 7DW
England
Poole
BH15 2JB
England
Harrow
HA1 3UJ
England
Redhill
RH1 5RH
England
Basingstoke
RG24 9NA
England
Stockton-on-tees
TS19 8PE
England
Swindon
SN3 6BB
England
Eaglestone
Milton Keynes
MK6 5LD
England
Winchester
SO22 5DG
England
Cottingham
HU16 5JX
England
Bedford
MK42 9DJ
England
Luton
LU4 0DZ
England
Isleworth
TW7 6AF
England
Walsgrave
Coventry
CV2 2DX
England
Dudley
DY1 2HQ
England
Oxford Road
Manchester
M13 9WL
England
Wythenshawe
Manchester
M23 9LT
England
Calow
Chesterfield
S44 5BL
England
Harrogate
HG2 7SX
England
Rotherham
S60 2UD
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 8 | 22/03/2024 | 23/07/2024 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 45760 NHSE CVLP Participant Information Sheet v8 22Mar2024.pdf
- Participant information sheet
Editorial Notes
10/04/2026: The following changes were made:
1. Health condition or problem studied was changed from "Cancer vaccine studies in various cancer types" to "Immunotherapy and cancer vaccine studies in various cancer types".
2. Date of final enrolment was changed from 31/03/2026 to 31/03/2028.
3. Scientific title was changed from "Establishing a UK platform to collect tumour samples and perform DNA/RNA sequencing for the development of personalised cancer vaccines" to "Establishing a UK platform to collect tumour samples and perform DNA/RNA sequencing for the development of personalised cancer vaccines and immunotherapies".
23/05/2025: Study participating centres were added.
22/05/2025: The recruitment end date was changed from 01/05/2025 to 31/03/2026.
09/07/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
