Clinical Trial: A Phase Ib Trial of MVA-EBNA1/LMP2 Vaccine in Nasopharyngeal Carcinoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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 (

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Cancer Research UK

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Cancer Research UK

Dates:
Date Received: February 25, 2013
Date Started: March 2013
Date Completion:
Last Updated: August 30, 2016
Last Verified: August 2016