MVA (EBV): A phase I, dose escalation trial of recombinant modified Vaccinia Ankara (MVA)-based vaccine encoding Epstein-Barr virus target antigens
 Chief Investigator:
 Dr Neil Steven
 Sponsor:  Cancer Research UK
 Funder:  CR UK Clinical Trials Unit
 Disease Site:   Mixed Primary Cancer
 Trial Type:   Investigational Medicinal Product
 Status:  Complete
 EudraCT Number:  2004-001931-46
 ClinicalTrials.Gov ID:  NCT01147991
 Open to New Sites?  No
 Recruitment Start Date: 11-Nov-2005
 Recruitment End Date: 31-Aug-2010
 CRCTU Trial Management Team:  EDD
 Trial Email Address:
Trial Summary

Summary of Trial Results

The research team found that the MVA-EBNA1/LMP2 vaccine was safe and suggest that it is looked at in further trials.

This phase 1 trial recruited 16 people with nasopharyngeal cancer. They had all had chemotherapy and radiotherapy already. They had the vaccine as an injection into the skin once every 3 weeks. The plan was to have 3 injections, and 14 of the 16 people taking part had all 3.

The first few people taking part had the lowest dose of the vaccine. The next few people had a higher dose, and so on until they found the best dose to give. This is called a dose escalation trial.

The research team looked at the immune response to the vaccine in a number of different ways. They found that

  • 3 out of the 13 people had an immune response to the vaccine after 2 doses
  • 5 out of the 13 people had an immune response to the vaccine after 3 doses
  • Specialist white blood cells called T cells recognised the vaccine in 9 out of 10 people
  • 6 out of 16 people had increased levels of proteins called antibodies in response to the vaccine

Everyone taking part in the trial had some side effects, but they were nearly all mild and didn’t last long. The most common side effects included

  • Redness, swelling or itching at the injection site
  • Flu-like symptoms
  • Increased risk of infection
  • Tiredness

The research team concluded that the MVA-EBNA1/LMP2 vaccine was safe. They suggest that, as it didn’t cause any serious side effects, the highest dose used in this trial could be looked at in further trials.

Read more at Cancer Research UK


A recombinant modified vaccinia ankara vaccine encoding Epstein-Barr Virus (EBV) target antigens: a phase I trial in UK patients with EBV-positive cancer

Clin Cancer Res. 2014 Oct 1;20(19):5009-22. doi: 10.1158/1078-0432.CCR-14-1122-T. Epub 2014 Aug 14.

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