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ISRCTN
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ISRCTN67270384
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ClinicalTrials.gov identifier
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Public title
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Therapeutic vaccination for chronic hepatitis B virus infection in Africa
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Scientific title
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Acronym
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HBSMVA
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Serial number at source
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060288
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Study hypothesis
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Chronic Hepatitis B Virus (HBV) infection, therapeutic vaccines, Deoxyribonucleic Acid (DNA) vaccine, recombinant modified vaccinia virus Ankara vaccine.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Gambia
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Disease/condition/study domain
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Hepatitis B virus
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Participants - inclusion criteria
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1. Chronic HBV infection
2. Male, 15 to 25 years
3. No evidence of liver inflammation or liver dysfunction
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Participants - exclusion criteria
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1. Egg allergy
2. Serious disorder of any body system
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Anticipated start date
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28/01/2002
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Anticipated end date
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31/10/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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77 - recruitment ends on the 10th January 2004
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Interventions
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This trial will take place in five parts:
1. An open label study in five healthy volunteers, of modified vaccinia virus Ankara (MVA.HBs) (a novel vaccine for HBV), then an open label non-randomised study in healthy volunteers of Deoxyribonucleic Acid vaccine (DNA.HBs) (another novel vaccine for HBV).
2. A study in 32 male ‘e’ antigen negative chronic carriers of HBV - four way randomisation:
a. Lamivudine 100 mg orally (po) daily for 14 weeks
b. DNA.HBs 1 mg twice followed by MVA.HBs twice
c. Both lamivudine and DNA and MVA vaccinations
d. Rabies vaccine three times as a control
3. A study in 16 male ‘e’ antigen positive chronic carriers of HBV - two way randomisation:
a. DNA.HBs 1 mg twice followed by MVA.HBs twice
b. Both lamivudine and DNA and MVA vaccinations
4. A non-randomised study in 12 ‘e’ antigen negative chronic carriers of DNA.HBs 2 mg twice followed by 1.5 x 10^8 of MVA.HBs once.
5. A non-randomised study in 12 ‘e’ antigen positive chronic carriers of Lamivudine 100 mg daily and DNA.HBs 2 mg twice followed by 1.5 x 10^8 of MVA.HBs once.
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Primary outcome measure(s)
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1. Local tolerogenicity
2. Adverse events
3. Cellular immune responses to overlapping peptides of Hepatitis B surface protein
4. HBV serology
5. Anti-HBs levels, surface antigen
6. 'e' antigen
7. HBV viral load
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 060288)
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Trial website
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Publications
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1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21347224
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Contact name
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Mr
Samuel Joseph
McConkey
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Address
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International Health and Tropical Medicine
Royal College of Surgeons in Ireland
123 St. Stephen's Green
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City/town
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Dublin
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Zip/Postcode
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2
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Country
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Ireland
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Tel
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+353 (0)1 402 2186
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Fax
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+353 (0)1 402 2462
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Email
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smcconkey@rcsi.ie
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Sponsor
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University of Oxford (UK)
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Address
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University Offices
Wellington Square
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City/town
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Oxford
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Zip/Postcode
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OX1 2JD
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Country
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United Kingdom
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Tel
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+44 (0)1865 270143
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Fax
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+44 (0)1865 280467
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Email
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research.services@admin.ox.ac.uk
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Sponsor website:
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http://www.ox.ac.uk/
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Date applied
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23/11/2005
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Last edited
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02/03/2011
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Date ISRCTN assigned
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23/11/2005
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