Modified Vaccinia Ankara (MVA) Vaccine Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01256853
First received: December 8, 2010
Last updated: December 21, 2011
Last verified: December 2011

December 8, 2010
December 21, 2011
September 2006
September 2010   (final data collection date for primary outcome measure)
To determine safety and to characterise the toxicity profile of MVA-EBNA1/LMP2 vaccine [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01256853 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • To assess changes in levels of EBV genome levels in plasma [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Modified Vaccinia Ankara (MVA) Vaccine Study
A Phase I, Dose Escalation Trial of Recombinant Modified Vaccinia Ankara (MVA)-Based Vaccine Encoding Epstein-Barr Virus Target Antigens

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).

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Nasopharyngeal Neoplasms
  • Epstein-Barr Virus Infections
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.
Experimental: MVA Vaccine
Intervention: Drug: MVA Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT01256853
VAC002
No
CCTU, Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Anthony TC Chan, MD, FRCP Department of Clinical Oncology, The Chinese University of Hong Kong
Chinese University of Hong Kong
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP