Therapeutic vaccination for chronic hepatitis B virus infection in Africa

ISRCTN	ISRCTN67270384
DOI	https://doi.org/10.1186/ISRCTN67270384
Protocol serial number	060288
Sponsor	University of Oxford (UK)
Funder	Wellcome Trust

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

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
Email	smcconkey@rcsi.ie

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/10/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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