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Trial of a new vaccine to treat incurable cancer expands to more UK sites

Published: 14 July 2022
Doctor and patient

A clinical trial to examine whether a new vaccine could be used to treat cancer patients who have run out of other treatment options is being expanded to more sites.

The clinical trial, run by the Cancer Research UK Southampton Clinical Trials Unit, aims to boost the immune system of people with cancers caused by the Human Papilloma Virus (HPV).

Following an initial stage of the trial to assess the safety of the new vaccine at University Hospital Southampton, the next phase has opened at The Christie in Manchester and is now recruiting patients.

HPV driven cancers

HPV is a common virus which has many different strains, most of which the body can clear without us even knowing we had it. But there are some strains which increase the risk of developing certain cancers such as head and neck, cervical, penile and anal cancers.

Vaccines work by boosting the immune system to help it recognise and fight infections from viruses, and a vaccine against HPV is already used in teenagers to protect girls and women from developing cervical cancer.

The HARE-40 clinical trial is testing a new vaccine against the HPV-16 strain in the hope that it can wake-up the immune system against the virus in people who already have cancer and where other treatment options have failed.

“At recurrence, HPV-driven cancers are often very difficult to treat with limited options if initial treatment is unsuccessful,” says Chief Investigator Professor Christian Ottensmeier. “Although similar vaccines have been given to people with cancer before, this is the first trial in which this particular vaccine against HPV-16 has been used in humans, and we are hopeful it could provide a better and kinder treatment for these patients.”

Expanding the trial in Manchester

The first part of the trial was carried out at University Hospital Southampton. People who had already been successfully treated for head and neck cancer that was caused by HPV-16 were given very low doses of the vaccine, which were slowly increased to see what dose could be safely tolerated.

Now, the second part of the trial is taking place both in Southampton and at The Christie in Manchester. This time the vaccine will be given to patients who currently have cancer to see what affect it has on their disease.

Dr Donna Graham, lead researcher for the trial and consultant oncologist at The Christie, said: “The patients taking part in this trial are undergoing palliative treatment because there are no curative treatment options available to them. Because this is the first time the vaccine has been given to people with active cancer, we don’t yet know whether it will help to control their disease, but the hope is that this vaccine will improve the patients’ immune response to HPV-16 and give these patients another potential treatment option.”


Ali Richards
Ali Richards

Ali Richards, 60, was diagnosed with throat cancer in 2016. After undergoing a course of gruelling radiotherapy and chemotherapy, and then surgery to remove lymph nodes in her neck, Ali was invited to take part in the first stage of the trial in Southampton.

“My primary motivation for getting involved was to help stop other people having to go through the brutal treatment regime that I did. I know I had the very best care available but believe that there has to be a better way.”

Ali has recently been given the all-clear from her oncologist and says that being part of research was a great experience.

“I'm really proud to have been involved and hope my participation will help to make a difference. My sincere hope is that we can stop this horrible disease for most if not all patients. Evidence of the benefits of HPV vaccines is already coming through in reduced cervical cancer rates and I would be so happy to have played a small role in developing a potential therapeutic vaccine for other HPV-triggered cancers.”

Researchers leading the latest stage of the trial will monitor the patients to see whether the vaccine leads to an increase in immune cells and any change in their cancer, as well as assessing how much of the vaccine can be given safely, without leading to too many side-effects.

The trial is funded by BioNTech SE, who produce the vaccine, with additional support from Cancer Research UK.

Notes for editors

HARE-40A therapeutic HPV vaccine trial +/- anti-CD40 in HPV-driven squamous cell carcinoma.

The CRUK Southampton Clinical Trials Unit (SCTU) is a Cancer Research UK core funded and National Institute for Health and Care Research (NIHR) supported CTU with expertise in the design, conduct and analysis of multicentre, interventional clinical trials. The CTU is based within the University of Southampton with offices at the University Hospital Southampton NHS Foundation Trust Southampton General Hospital site. Visit the SCTU website

About The Christie:

  • The Christie is a specialist cancer centre in Manchester and has more than 120 years of expertise in cancer care, research and education. It is one of Europe’s leading cancer centres, treating over 60,000 patients a year.
  • It is the largest provider of radiotherapy in the NHS (including high energy proton beam therapy and MR guided radiotherapy); it is home to the largest chemotherapy unit in the UK; and is a specialist surgical centre concentrating on rare cancers and complex procedures.
  • The Christie is one of Europe's largest experimental cancer medicine centres and an international leader in research and development with around 650 clinical studies ongoing at any one time.
  • The Christie charity provides enhanced services for patients over and above what the NHS funds.

 Visit to find out more or follow The Christie on social media @TheChristieNHS

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