Nasopharyngeal NeoplasmsPhase 1NCT01256853
Modified Vaccinia Ankara (MVA) Vaccine Study
A Phase 1 study testing MVA Vaccine in people with Nasopharyngeal Neoplasms and Epstein-Barr Virus Infections, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Neoplasms, Epstein-Barr Virus Infections
- What is being tested?
- MVA Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2006to Sep 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
About this study
Official title: 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).
- Being tested
- MVA Vaccine
- Keywords
- histologically confirmed EBV+ NPC patients
- Medical subject headings
- Nasopharyngeal Neoplasms, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA VaccineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| MVA Vaccine | Experimental | Not described Receives: Drug: MVA Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine safety and to characterise the toxicity profile of MVA-EBNA1/LMP2 vaccine
Measured: 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.
Measured: 4 years
To assess changes in levels of EBV genome levels in plasma
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startSep 2006
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CCTU, Chinese University of Hong Kong
- Investigators
- Anthony TC Chan, MD, FRCP, Principal investigator, Department of Clinical Oncology, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256853
- Sponsor's protocol ID
- VAC002
- Status last verified
- Dec 2011
- First submitted
- 8 Dec 2010
- Last updated
- 22 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Dose Escalation Trial of Recombinant Modified Vaccinia Ankara (MVA)-Based Vaccine Encoding Epstein-Barr Virus Target Antigens
- ClinicalTrials.gov ID
- NCT01256853
- Acronym / sponsor ID
- VAC002
- Keywords
- histologically confirmed EBV+ NPC patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MVA Vaccine | Experimental | Drug: MVA Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVA VaccineThe 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. | Drug | MVA Vaccine |
Primary outcome
To determine safety and to characterise the toxicity profile of MVA-EBNA1/LMP2 vaccine
Time frame: 4 years
2 secondary outcomes
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
To assess changes in levels of EBV genome levels in plasma
Time frame: 4 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony TC Chan, MD, FRCP principal investigator
Department of Clinical Oncology, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MVA Vaccine in people with Nasopharyngeal Neoplasms and Epstein-Barr Virus Infections, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine safety and to characterise the toxicity profile of MVA-EBNA1/LMP2 vaccine (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2011.