This clinical study is looking at a vaccine called MVA-EBNA1/LMP2. This is a new vaccine that has already been studied in small number of cancer patients. The vaccine is designed to boost a patient's immunity against a common virus. The virus is called Epstein Barr virus or EBV. EBV is sometimes found inside cancer cells and is commonly found in nasopharyngeal cancer cells.
The main aims of the clinical study are to find out more about how the immune system responds to the vaccine, more about the potential side effects of the vaccine and the effects of giving an additional booster vaccination on the immune system. Approximately 18 patients with EBV positive nasopharyngeal cancer (NPC) will be recruited to the trial. Patients will receive up to four vaccinations with the MVA-EBNA1/LMP2 vaccine. The first three vaccines will be given at 3 weekly intervals, followed by a fourth vaccine 12 weeks later. The vaccine will be given by intradermal injection with the dose divided across multiple injection sites on the arm, or on the thigh. Patients will participate in the study for approximately 12 months from first vaccination and attend hospital approximately 11 times during this period. Standard safety assessments will be performed throughout the trial and at each clinic visit patients will be asked to provide research blood samples. These samples will be used to monitor the effects of the vaccine on the patient's immune system.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
22
University of Birmingham
Edgbaston, Birmingham, United Kingdom
Royal Marsden Hospital
Fulham Road, London, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
The Beatson West of Scotland Cancer
Glasgow, United Kingdom
Immune response to three cycles of MVA-EBNA1/LMP2 vaccine
To be determined by ex vivo ELIspot assays quantifying EBV EBNA1 and LMP2-specific effectors in samples before vaccination, during the three cycle vaccine course and within 4 weeks after the third vaccine cycle.
Time frame: pre-vaccination to 4 weeks post third vaccine
Occurrence of adverse events defined according to NCI CTCAE version 4.02
Time frame: 12 months
Immune memory and recall response to MVA-EBNA1/LMP2 vaccination
To be determined by ex vivo ELIspot assays quantifying EBV EBNA1 and LMP2-specific effectors in samples before and within 4 weeks after the first and fourth vaccine cycles
Time frame: pre and post vaccines one and four.
Measurement of EBV genome levels in plasma before, during and after vaccination
Time frame: pre- vaccination to 12 months post vaccination
Tumour response as determined by Immune-Related Response Criteria (irRC)
Time frame: 6 months
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The Christie Hospital
Manchester, United Kingdom