Scientists in the United Kingdom have started a Phase 1 study to test the efficacy and safety of a cancer vaccine that might enable the immune system to fight solid tumor cancers, including cervical cancer, in patients no longer responding to traditional treatments.
If the vaccine ultimately shows effectiveness and is approved, it could be used to treat cancers of any solid tumor type, regardless of the tumor’s genetic profile.
The VAPER trial, which is currently enrolling advanced cancer patients age 16 or older, is being conducted at the National Institute for Health Research (NIHR) Guy’s and St Thomas’ Clinical Research Facility, London, and the NIHR Biomedical Research Centre (BRC) at Guy’s and St Thomas’ NHS Foundation Trust and at King’s College London. Other research sites in Surrey are expected to open later this year.
The vaccine is composed of hTERT peptides, and works by mimicking natural immune responses generated to fight viral and bacterial infections. Trial participants will be given the vaccine once every three weeks, for eight treatment cycles, along with low-dose cyclophosphamide (chemotherapy) tablets. Some will be randomized to also receive celecoxib, a non-steroidal anti-inflammatory drug.
“We know that the immune system in patients with advanced cancer is suppressed, so it’s unable to recognise and kill cancer calls. In this trial we are investigating a form of immunotherapy designed to activate the body’s immune system by administration of a vaccine based on fragments of a key cancer protein,” Professor Hardev Pandha, director of the Surrey Cancer Research Institute (SCRI) and one of the trial’s principal investigators, said in a press release.
Two patients have already received the vaccine in the trial, which is planned to run for 18 to 24 months. It includes two distinct parts, with the second part only starting if at least one patient demonstrates a positive response to the vaccine. Up to 10 people will be enrolled in part one, and up to 20 in part two.
“The unique feature of this study is the use of additional agents to boost the vaccination response. It is hoped this will abolish the inhibitory effect of regulatory immune cells present in the patients’ circulation, which are believed to have limited the effectiveness of previous cancer vaccine approaches,” said Dr. James Spicer, principal investigator at the BRC and King’s College.
The trial is supported by data from related trials conducted in the U.K, the U.S., and Europe. “This trial is pushing new boundaries for potential cancer treatments, and brings new hope for patients in the fight against cancer,” said George Freeman, U.K. minister for Life Sciences. “The prospect of a vaccine to help the body’s immune system fight advanced cancer highlights the ground-breaking work being delivered by our world-leading life sciences sector, supported through the Government’s continued investment in the National Institute for Health Research.”
Kelly Potter, a 35-year-old Beckenham resident with stage 4 cervical cancer, has already received a first vaccine treatment. Her experience to date has been positive. “When I was told that I may be eligible for this trial, I was delighted. When I read the leaflet about the VAPER trial it struck me that it seemed a bit of breakthrough and that if it worked, it could be a revolution in the treatment of cancer. To be part of the trial has changed my life for the better. It’s been a very positive experience and really interesting,” she said.
“I had my first injection on Tuesday 9th February and have another seven visits to complete the treatment. They did say there may be flu like symptoms but I haven’t noticed anything yet. The way I have been cared for and treated by the clinical trial staff is exceptional,” Potter said. “My hope for the future is to beat the cancer for as long as I can.”
More information about the VAPER trial, including enrollment information, can be found through this link.