A Phase Ib Trial of MVA-EBNA1/LMP2 Vaccine in Nasopharyngeal Carcinoma
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.
|Nasopharyngeal Cancer Epstein Barr Virus Infections||Drug: MVA-EBNA1/LMP2 vaccine||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Cancer Research UK (CR-UK) Phase Ib Trial to Determine the Safety, Tolerability and Immunogenicity of Extended Schedule Vaccination With MVA-EBNA1/LMP2 in Patients With Epstein Barr Virus Positive (EBV+) Nasopharyngeal Carcinoma (NPC).|
- Immune response to three cycles of MVA-EBNA1/LMP2 vaccine [ Time Frame: pre-vaccination to 4 weeks post third 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.
- 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 [ Time Frame: pre and post vaccines one and four. ]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
- 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 ]
|Study Start Date:||March 2013|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01800071
|University of Birmingham|
|Edgbaston, Birmingham, United Kingdom, B15 2TT|
|Royal Marsden Hospital|
|Fulham Road, London, United Kingdom, SW3 6JJ|
|Velindre Cancer Centre|
|Cardiff, United Kingdom, CF14 2TL|
|The Beatson West of Scotland Cancer|
|Glasgow, United Kingdom, G12 0YN|
|The Christie Hospital|
|Manchester, United Kingdom, M20 4BX|