Modified Vaccinia Ankara (MVA) Vaccine Study

NCT01256853 | Completed Phase 1

• 1 other identifier: VAC002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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).

Conditions

Nasopharyngeal Neoplasms; Epstein-Barr Virus Infections

Keywords

histologically confirmed EBV+ NPC patients

Outcome Measures

Primary Outcomes (1)

• To determine safety and to characterise the toxicity profile of MVA-EBNA1/LMP2 vaccine

  4 years

Secondary Outcomes (2)

• 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

Study Arms (1)

MVA Vaccine

EXPERIMENTAL

Drug: MVA Vaccine

Interventions

MVA Vaccine DRUG

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.

MVA Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Epstein-Barr Virus Infections

Interventions

MVA vaccine

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Study Officials

• Anthony TC Chan, MD, FRCP

  Department of Clinical Oncology, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Comprehensive Clinical Trial Unit

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 9, 2010
• Study Start: September 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 22, 2011

Record last verified: 2011-12

Locations

HK (1)