A trial of a vaccine for cancers that tested positive to the human papilloma virus (HARE-40)

Cancer type:

Anal cancer
Cervical cancer
Head and neck cancers
Penile cancer
Vaginal cancer
Vulval cancer

Status:

Open

Phase:

Phase 1/2

This trial is looking at a vaccine called RNA for people with cancer that tested positive to the human papilloma virus (HPV positive). 

HPV positive cancers can include: 

More about this trial

The human papilloma virus (HPV) is a common virus. There are different types of HPV and most don’t cause any serious problems. But some types, such as HPV16, can cause changes to cells that can develop into cancer. 

In this trial doctors are looking at a new vaccine called RNA. It has been made in the laboratory to help the immune system to recognise and attack HPV16.

There are 2 groups (arms) in this trial:

  • people who have had treatment for head and neck cancer that tested positive for HPV16 and there is no sign of the cancer coming back (arm 1A)
  • people with any type of cancer that has tested positive to HPV16 and doctors think they can’t be cured (arm 1B)

The main aims of this trial are to:

  • find the highest safe dose of RNA vaccine that can be given
  • learn about the side effects
  • find out how well the RNA vaccine works as a treatment
  • find out if the RNA vaccine increases the number of immune system cells such as white blood cells in the body

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

Who can enter

You may be able to join this trial if all of the following apply.

  • You are at least 18 years old
  • You have good veins that the team can access to get blood samples and do leukapheresis 
  • You are willing to use reliable contraception during treatment and for a month afterwards if there is any possibility you or your partner could become pregnant 

You may be able to join the arm 1A if all of the following also apply.

  • You have had treatment for a head and neck cancer that tested positive to HPV16 more than a year but less than 5 years ago
  • There is no sign of your cancer coming back
  • You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1) 

You may be able to join arm 1B if all of the following also apply.

  • Your cancer has tested positive to HPV16 and has come back after treatment
  • Doctors think your cancer can no longer be cured
  • You are willing to have samples of your cancer taken (a biopsy)
  • You have a suitable sample of tissue available to be tested for HPV (your doctor will check this)

Who cannot enter

You cannot join this trial if any of these apply.

Cancer related

  • You have had a RNA vaccine
  • You have, or have had, another cancer apart from basal or squamous cell skin cancer that has been successfully treated, any other cancer that was treated with the aim of curing you, there has been no sign of it for at least 5 years in arm 1A and at least 2 years in arm 1B and there is a low risk of it coming back

Medical conditions

  • You have an autoimmune disease that your doctor thinks could affect you taking part 
  • You have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the past 2 weeks, unless this was to replace something that the body makes such as cortisol
  • You have heart problems such as congestive heart failure or any other condition that causes tiredness (fatigue) or shortness of breath when you are exercising
  • You have high levels of liver enzymes in your body
  • You have HIV
  • You have hepatitis B or hepatitis C
  • You have syphilis
  • You have had an experimental drug in the past 28 days
  • You have had a major surgery in the past 3 or 4 weeks and you still have side effects from it 
  • You have a serious infection that is not being controlled by medication
  • You have any other serious medical condition that the trial team thinks could affect you taking part in this trial 
  • You are known to have severe allergies 

Other

  • You are pregnant or breastfeeding 

Trial design

This is an international phase 1/2 trial. The researchers need up to 40 people from the UK to take part. 

This trial has 2 groups (arms): 

  • arm 1a – doctors need around 15 people who have been successfully treated for HPV16 positive head and neck cancer to join this arm
  • arm 1b – doctors need around 29 people with other types of HPV16 positive cancer who cannot be cured to join this arm

The dose of the 1st RNA vaccine you have depends on when you join the trial. You start on a small dose and if you don’t have any serious side effects, you have a higher dose for the next vaccine. And so on, until doctors find the best dose. 

You have the vaccine once a week for a month. Then you have it every 2 weeks. You have up to 8 RNA vaccines. 

You may be able to continue to have the RNA vaccine if you are in arm 1B and your doctor thinks the vaccines are helping you. This is called continued dosing. Your doctor can tell you more about this. 
 
Blood tests
You have some extra blood tests as part of this trial. Researchers want to:

  • study how much protection against HPV 16 your immune system has (your immune memory to HPV)
  • look at the immune system cells
  • look for certain proteins (markers) that can tell how well the immune system works

You have the extra blood tests before starting treatment and at set times during the trial. 

Sample of immune cells 
The research team might ask for a large sample of your immune system cells. You have these cells collected using a process called leukapheresis. 

To have leukapheresis you have a tube into a vein. The tube removes blood that then passes into a machine that takes the white blood cells. The rest of your blood cells and the blood fluid (plasma) then go back into your body through another tube. 

You have the leukapheresis after the end of treatment. It takes about 3 hours.

Tissue sample 
The trial team will ask to use a tissue sample of your cancer taken either when you were diagnosed or during any treatment you have had. They will look at the cancer and the immune system cells. 
       
They might also ask you to have new tissue samples taken if you are in arm 1B. You have it before the start of treatment and then:

  • at the end of treatment
  • if your cancer gets worse 

Hospital visits

You see a doctor and have some tests before taking part. These tests might include: 

  • a physical examination
  • blood tests
  • urine test
  • a CT scan or MRI scan (if you are in group 1B)

You need to stay in hospital for a few hours after each vaccine. The amount of time you stay depends on when you join the trial. The first few people taking part will need to stay in hospital for up to 24 hours after each vaccine.  

During treatment you see the doctor for blood tests and a physical examination every week, for 4 weeks. You then see the doctor every 2 weeks. This continues for about 3 months. 

If you are in group 1B you have a CT scan or MRI scan about 6 weeks after your 1st vaccination. 

When you finish treatment you see the trial doctor 3 months after your last vaccine. You then have regular follow up for 2 years. This could be over the phone or in a clinic. The trial team might also phone your GP.

If you are in group 1B, you have a CT scan or MRI scan at 3 months. 

Side effects

This is the first time the RNA vaccine has been given to people so there may be side effects we don’t know about yet. 

The trial team monitor you during the time you have treatment and you have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.

Researchers think the most common side effects of RNA vaccine are likely to be:

  • a high temperature (fever) and chills or shivers
  • skin rash and swelling around the injection site
  • shortness of breath
  • fast heart beat and low blood pressure that might cause fainting
  • shivering or chills
  • sweating
  • tiredness (fatigue)
  • being sick
  • muscle weakness
  • fits (seizures)
  • dizziness and headaches
  • high levels of liver enzymes
  • changes in the number of immune cells
  • a drop in the number of platelets (causing a risk of bleeding)  

Location

Southampton

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Christian Ottensmeier

Supported by

Experimental Cancer Medicine Centre (ECMC)
National Cancer Research Institute (NCRI)
Southampton University Hospital NHS Foundation Trust
Southampton Clinical Trials Unit (SCTU)
University of Southampton 

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14552

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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