Therapeutic vaccination for chronic hepatitis B virus infection in Africa
| ISRCTN | ISRCTN67270384 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67270384 |
| Secondary identifying numbers | 060288 |
- Submission date
- 23/11/2005
- Registration date
- 23/11/2005
- Last edited
- 06/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Samuel Joseph McConkey
Scientific
Scientific
International Health and Tropical Medicine
Royal College of Surgeons in Ireland
123 St. Stephen's Green
Dublin
2
Ireland
| Phone | +353 (0)1 402 2186 |
|---|---|
| smcconkey@rcsi.ie |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Therapeutic vaccination for chronic hepatitis B virus infection in Africa |
| Study acronym | HBSMVA |
| Study objectives | Chronic Hepatitis B Virus (HBV) infection, therapeutic vaccines, Deoxyribonucleic Acid (DNA) vaccine, recombinant modified vaccinia virus Ankara vaccine. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 28/01/2002 |
| Completion date | 31/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 77 |
| Key inclusion criteria | 1. Chronic HBV infection 2. Male, 15 to 25 years 3. No evidence of liver inflammation or liver dysfunction |
| Key exclusion criteria | 1. Egg allergy 2. Serious disorder of any body system |
| Date of first enrolment | 28/01/2002 |
| Date of final enrolment | 10/01/2004 |
Locations
Countries of recruitment
- Gambia
- Ireland
Study participating centre
International Health and Tropical Medicine
Dublin
2
Ireland
2
Ireland
Sponsor information
University of Oxford (UK)
University/education
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
| Phone | +44 (0)1865 270143 |
|---|---|
| research.services@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
Wellcome Trust
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/02/2011 | Yes | No |
