Modified Vaccinia Ankara (MVA) Vaccine Study

Phase 1

Completed

• Conditions: Nasopharyngeal Neoplasms; Epstein-Barr Virus Infections
• Interventions: Drug: MVA Vaccine

• Registration Number: NCT01256853
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2010-12-08
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-21
• Last Update Posted: 2011-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MVA Vaccine	MVA Vaccine	-

Primary Outcome Measures

Name	Time	Method
To determine safety and to characterise the toxicity profile of MVA-EBNA1/LMP2 vaccine	4 years

Secondary Outcome Measures

Name	Time	Method
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.	4 years
To assess changes in levels of EBV genome levels in plasma	4 Years

Trial Locations

Locations (1)

Department of Clinical Oncology, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong