TH HBV VV-031 HBS:001 (207811)
Research type
Research Study
Full title
Ancillary study evaluating ChAd155-hIi-HBV shedding in a subset of chronic hepatitis B patients enrolled in the first-time-in-human, Phase I, randomised, multi-centric, single-blind study TH HBV VV-001
IRAS ID
_260119
Contact name
Patrick Kennedy
Contact email
Sponsor organisation
GlaxoSmithKline Biologicals
Eudract number
2017-002574-39
Duration of Study in the UK
0 years, 11 months, 15 days
Research summary
This is a supplemental study to the main GSK sponsored study, TH HBV VV-001, in which the patient has agreed to participate. Only 76 patients globally in Step B will be asked to take part. The number of patients in the UK going into Step B will depend on competitive recruitment with the other countries. Participation in the study is optional for the patient. In the main study, the patient will receive a vaccine which could contain a harmless virus, called chimpanzee adenovirus. The virus has been changed and lost the ability to spread thus is a “broken/ineffective” virus. It will not cause infection and will not cause disease in people. This study is to test whether this “broken/ineffective” virus could have any potential to release into urine or the surface of the throat.
This study will last 31 days and patients would need to visit the clinic at least 5 times. The visits are on the same days as other visits planned for the TH HBV VV-001 study. A urine sample and a throat sample will be taken 5 times during the research study.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/0335
Date of REC Opinion
2 Apr 2019
REC opinion
Unfavourable Opinion