Condition category
Infections and Infestations
Date applied
23/11/2005
Date assigned
23/11/2005
Last edited
06/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.ox.ac.uk/

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

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

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21347224

Publication citations

  1. 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.

Additional files

Editorial Notes