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A Cancer Research UK (CR-UK) Phase Ib Trial to Determine the Safety, Tolerability and Immunogenicity of Extended Schedule Vaccination With MVA-EBNA1/LMP2 in Patients With Epstein Barr Virus Positive (EBV+) Nasopharyngeal Carcinoma (NPC).

Phase 1
18 Years
Open (Enrolling)
Nasopharyngeal Cancer, Epstein Barr Virus Infections

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Trial Information

A Cancer Research UK (CR-UK) Phase Ib Trial to Determine the Safety, Tolerability and Immunogenicity of Extended Schedule Vaccination With MVA-EBNA1/LMP2 in Patients With Epstein Barr Virus Positive (EBV+) Nasopharyngeal Carcinoma (NPC).

The main aims of the clinical study are to find out more about how the immune system
responds to the vaccine, more about the potential side effects of the vaccine and the
effects of giving an additional booster vaccination on the immune system.

Approximately 18 patients with EBV positive nasopharyngeal cancer (NPC) will be recruited to
the trial. Patients will receive up to four vaccinations with the MVA-EBNA1/LMP2 vaccine.
The first three vaccines will be given at 3 weekly intervals, followed by a fourth vaccine
12 weeks later. The vaccine will be given by intradermal injection with the dose divided
across multiple injection sites on the arm, or on the thigh.

Patients will participate in the study for approximately 12 months from first vaccination
and attend hospital approximately 11 times during this period. Standard safety assessments
will be performed throughout the trial and at each clinic visit patients will be asked to
provide research blood samples. These samples will be used to monitor the effects of the
vaccine on the patient's immune system.

Inclusion Criteria:

1. Histologically confirmed NPC in which the presence of EBV has been confirmed in the
tumour by immunohistochemistry for viral antigens or EBV early RNA (EBER) fluorescent
in situ hybridisation (FISH).

2. Patients in remission or with current disease for whom no standard therapy is
currently appropriate or required.

3. Patients who have received primary treatment for their malignancy (radiotherapy ±
chemotherapy) and up to one additional second-line course of therapy.

4. Life expectancy of at least 6 months.

5. World Health Organisation (WHO) performance status of 0 or 1 (Appendix 1).

6. Haematological and biochemical indices within the ranges shown below. These
measurements must be performed within one week (Day -7 to Day 1) before the patient
receives their first vaccination with MVA-EBNA1/LMP2.

Laboratory Test Value required Haemoglobin (Hb)
≥10.0 g/dL, Lymphocyte count ≥0.5 x
10^9/L after ≥ 6 weeks have elapsed from completion of chemotherapy, Absolute
neutrophil count (ANC) ≥1.0 x 10^9/L, Platelet count
≥ 75 x 10^9/L, Serum bilirubin ≤1.5 x upper limit of normal
(ULN), Alkaline phosphatase (ALP) AND alanine aminotransferase (ALT) OR aspartate
aminotransferase (AST) ≤ 2.5 x ULN, Calculated creatinine clearance
≥50 mL/min (uncorrected value)

7. 18 years or over.

8. Written (signed and dated) informed consent and be capable of co-operating with
treatment and follow-up.

Exclusion criteria

1. Radiotherapy, chemotherapy, endocrine therapy, immunotherapy or investigational
medicinal products within 6 weeks prior to trial entry.

2. Patients who, in the opinion of the investigator and multidisciplinary team managing
the patient, may require another oncological treatment within 14 weeks of the first

3. Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia
or Grade 1 toxicities, which in the opinion of the Investigator and the Sponsor
should not exclude the patient.

4. Current active auto-immune disease requiring therapy.

5. Current active eczema requiring therapy.

6. Allergy to eggs or egg products.

7. History of anaphylaxis or severe allergy to previous vaccinations or medications.
Patients with a documented history of allergy to gentamicin should be discussed with
the Sponsor prior to trial entry.

8. Previous splenectomy or splenic radiation, or with known splenic dysfunction.

9. Receiving current immunosuppressive medication including systemic use of
corticosteroids. Prophylactic use of inhaled steroids is permitted.

10. Ability to become pregnant (or already pregnant or lactating). However, those female
patients who have a negative serum or urine pregnancy test before enrolment and agree
to use two highly effective forms of contraception (oral, injected or implanted
hormonal contraception and condom, have a intra-uterine device and condom, diaphragm
with spermicidal gel and condom) during the trial and for six months afterwards are
considered eligible.

11. Male patients with partners of child-bearing potential (unless they agree to take
measures not to father children by using one form of highly effective contraception
[condom plus spermicide] during the trial and for six months afterwards). Men with
pregnant or lactating partners should be advised to use barrier method contraception
(for example, condom plus spermicidal gel) to prevent exposure to the foetus or

12. Major thoracic or abdominal surgery from which the patient has not yet recovered.

13. At high medical risk because of non-malignant systemic disease including active
uncontrolled infection.

14. Known to be serologically positive for hepatitis B, hepatitis C or human
immunodeficiency virus (HIV).

15. Concurrent congestive heart failure, prior history of class III/ IV cardiac disease
(New York Heart Association [NYHA]), prior history of cardiac ischaemia or prior
history of cardiac arrhythmia.

16. Any other condition which in the Investigator‟s opinion would not make the patient a
good candidate for the clinical trial.

17. Is a participant or plans to participate in another interventional clinical trial,
whilst taking part in this Phase Ib study of MVA-EBNA1/LMP2. Participation in an
observational trial would be acceptable.

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Immune response to three cycles of MVA-EBNA1/LMP2 vaccine

Outcome Description:

To be determined by ex vivo ELIspot assays quantifying EBV EBNA1 and LMP2-specific effectors in samples before vaccination, during the three cycle vaccine course and within 4 weeks after the third vaccine cycle.

Outcome Time Frame:

pre-vaccination to 4 weeks post third vaccine

Safety Issue:



United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

March 2013

Completion Date:

Related Keywords:

  • Nasopharyngeal Cancer
  • Epstein Barr Virus Infections
  • Nasopharyngeal cancer
  • Epstein Barr Virus Infections
  • Vaccination
  • Carcinoma
  • Virus Diseases
  • Epstein-Barr Virus Infections
  • Nasopharyngeal Neoplasms