Modified Vaccinia Ankara (MVA) Vaccine Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01256853
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : December 22, 2011
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong

Brief Summary:
This is a phase I, dose escalation trial of MVA-EBNA1/LMP2 vaccine across a pre-defined range of doses in patients in remission having had an EBV+ nasopharyngeal carcinoma (NPC).

Condition or disease Intervention/treatment Phase
Nasopharyngeal Neoplasms Epstein-Barr Virus Infections Drug: MVA Vaccine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Dose Escalation Trial of Recombinant Modified Vaccinia Ankara (MVA)-Based Vaccine Encoding Epstein-Barr Virus Target Antigens
Study Start Date : September 2006
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
Experimental: MVA Vaccine Drug: MVA Vaccine
The starting dose will be 5 x 107 plaque forming units (pfu) given by intradermal vaccination. Cohorts of three patients will receive escalating doses of the vaccine (100%, 100%, 67% and 50%). The dose escalation scheme is 5 x 107 pfu, 1 x 108 pfu, 2 x 108 pfu, 3.3 x 108 pfu, 5 x 108pfu. This will be dependant on toxicity.

Primary Outcome Measures :
  1. To determine safety and to characterise the toxicity profile of MVA-EBNA1/LMP2 vaccine [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. To describe changes in the frequency of functional T-cell responses to MHC class I and II-restricted epitopes within EBNA1 and LMP2 in peripheral blood at sequential time-points before, during and up to nine months after the vaccination course. [ Time Frame: 4 years ]
  2. To assess changes in levels of EBV genome levels in plasma [ Time Frame: 4 Years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed NPC, in which the presence of EBV within the malignant cells has been demonstrated by (1) EBER (EBV early RNA) in situ hybridisation in more than 50% of the malignant cells, or (2) undifferentiated or poorly differentiated carcinoma histology in association with a raised serum titer of IgA to EBV VCA.
  • Patients in remission from disease, ie complete response (CR) or unconfirmed complete response (CRu).
  • Completion of standard therapy for malignancy at least 12 weeks before trial entry.
  • Written informed consent and the ability of the patient to co-operate with treatment and follow up must be ensured and documented.
  • Age greater than 18 years.
  • World Health Organisation (WHO) performance status of 0 or 1
  • Life expectancy of at least 4 months.
  • Haematological and biochemical indices (these measurements must be performed within 28 days prior to the patient going on study):

    • Haemoglobin (Hb) > 10.0 g/dl
    • Lymphocytes > 1.0 x 109/L (or above the lower limit of normal range of institutional laboratory)
    • Neutrophils ≥ 1.5 x 109/L
    • Platelets (Plts) ≥ 100 x 109/L
    • baseline liver function tests :
    • Serum bilirubin ≤ 1.5 x upper normal limit
    • Serum alkaline phosphatase, alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) < 1.5 x ULN.
    • baseline renal function test:
    • calculated creatinine clearance > 50ml/min Female patients of child-bearing potential are eligible, provided they have a negative pregnancy test prior to enrolment and agree to use appropriate medically approved contraception during the study up to six months after the last vaccination.
  • Male patients must agree to use appropriate medically approved contraception during the study up to six months after the last vaccination.

Exclusion Criteria:

  • Receiving current chemotherapy or radiotherapy, or received within 12 weeks of trial entry.
  • Known chronic active infection with Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
  • Current active autoimmune disease.
  • Current active skin diseases requiring therapy (psoriasis, eczema etc).
  • Ongoing active infection.
  • History of anaphylaxis or severe allergy to vaccination.
  • Allergy to eggs or egg products.
  • Previous myeloablative therapy followed by an autologous or allogeneic haematopoietic stem cell transplant.
  • Patients who have had a splenectomy or splenic irradiation, or with known splenic dysfunction.
  • Receiving current immunosuppressive medication, including corticosteroids.
  • Pregnant and lactating women.
  • Ongoing toxic manifestations of previous treatment. Exceptions to this are alopecia or certain Grade 1 toxicities which in the opinion of the Investigator and Cancer Research UK should not exclude the patient.
  • Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not yet recovered.
  • Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
  • Concurrent congestive heart failure or prior history of class III/ IV cardiac disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01256853

Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Anthony TC Chan, MD, FRCP Department of Clinical Oncology, The Chinese University of Hong Kong

Responsible Party: CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong Identifier: NCT01256853     History of Changes
Other Study ID Numbers: VAC002
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: December 22, 2011
Last Verified: December 2011

Keywords provided by CCTU, Chinese University of Hong Kong:
histologically confirmed EBV+ NPC patients

Additional relevant MeSH terms:
Virus Diseases
Epstein-Barr Virus Infections
Nasopharyngeal Neoplasms
Poxviridae Infections
DNA Virus Infections
Herpesviridae Infections
Tumor Virus Infections
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Immunologic Factors
Physiological Effects of Drugs