Contact information
Type
Scientific
Primary contact
Mr Samuel Joseph McConkey
ORCID ID
Contact details
International Health and Tropical Medicine
Royal College of Surgeons in Ireland
123 St. Stephen's Green
Dublin
2
Ireland
+353 (0)1 402 2186
smcconkey@rcsi.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
060288
Study information
Scientific title
Therapeutic vaccination for chronic hepatitis B virus infection in Africa
Acronym
HBSMVA
Study hypothesis
Chronic Hepatitis B Virus (HBV) infection, therapeutic vaccines, Deoxyribonucleic Acid (DNA) vaccine, recombinant modified vaccinia virus Ankara vaccine.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Hepatitis B virus
Intervention
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:
2.1. Lamivudine 100 mg orally (po) daily for 14 weeks
2.2. DNA.HBs 1 mg twice followed by MVA.HBs twice
2.3. Both lamivudine and DNA and MVA vaccinations
2.4. Rabies vaccine three times as a control
3. A study in 16 male e antigen positive chronic carriers of HBV - two way randomisation:
3.1. DNA.HBs 1 mg twice followed by MVA.HBs twice
3.2. 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.
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measure
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
Secondary outcome measures
No secondary outcome measures
Overall trial start date
28/01/2002
Overall trial end date
31/10/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Chronic HBV infection
2. Male, 15 to 25 years
3. No evidence of liver inflammation or liver dysfunction
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
77
Participant exclusion criteria
1. Egg allergy
2. Serious disorder of any body system
Recruitment start date
28/01/2002
Recruitment end date
10/01/2004
Locations
Countries of recruitment
Gambia
Trial participating centre
International Health and Tropical Medicine
Dublin
2
Ireland
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270143
research.services@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21347224
Publication citations
-
Results
Cavenaugh JS, Awi D, Mendy M, Hill AV, Whittle H, McConkey SJ, Partially randomized, non-blinded trial of DNA and MVA therapeutic vaccines based on hepatitis B virus surface protein for chronic HBV infection., PLoS ONE, 2011, 6, 2, e14626, doi: 10.1371/journal.pone.0014626.