Ancillary study on a sub-population of the chronic hepatitis B patients enrolled in the TH HBV VV-001 study to investigate the potential shedding of ChAd155-hIi-HBV after intramuscular administration

Ancillary study evaluating ChAd155-hIi-HBV shedding in a subset of chronic hepatitis B patients enrolled in the first-time-in-human, Phase I/II, randomised, multi-centric, single-blind study TH HBV VV-001 - TH HBV VV-031 HBS:001

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002574-39-DE

Enrollment

Registered

2018-04-20

Start date

2018-11-08

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis B MedDRA version: 20.1 Level: PT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: TH HBV adjuvanted recombinant proteins vaccine (80-80) Product Code: HBc-HBs/AS01B-4 80-80 vaccine component Pharmaceutical Form: Powder and suspension for suspension for injection INN o

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Patients who, in the opinion of the investigator, can and will comply with the requirements of the protocol. •Written informed consent obtained from the patient prior to performance of any study specific procedure. •Patients who met all inclusion criteria and were randomised to the Step B of the TH HBV VV-001 study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38

Exclusion criteria

Exclusion criteria: Patients met any exclusion criterion of the TH HBV VV-001 study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the shedding of ChAd155-hIi-HBV following intramuscular administration. ;Secondary Objective: NA;Primary end point(s): Number of subjects with Chimpanzee Adenovirus (ChAd)155 vector Deoxyribonucleic Acid (DNA) in throat swab above the limit of detection (LOD) of the quantitative polymerase chain reaction (qPCR) assay Number of subjects with ChAd155 vector DNA in urine above the LOD of the qPCR assay;Timepoint(s) of evaluation of this end point: At Day 1, 3, 8, 15, 31 At Day 1, 3, 8, 15, 31	—

Measure

Time frame

Main Objective: To assess the shedding of ChAd155-hIi-HBV following intramuscular administration. ;Secondary Objective: NA;Primary end point(s): Number of subjects with Chimpanzee Adenovirus (ChAd)155 vector Deoxyribonucleic Acid (DNA) in throat swab above the limit of detection (LOD) of the quantitative polymerase chain reaction (qPCR) assay Number of subjects with ChAd155 vector DNA in urine above the LOD of the qPCR assay;Timepoint(s) of evaluation of this end point: At Day 1, 3, 8, 15, 31 At Day 1, 3, 8, 15, 31

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Belgium, France, Germany, Hong Kong, Spain, Taiwan, Thailand, United Kingdom

Contacts

Public ContactClinical Disclosure Advisor

GlaxoSmithKline Biologicals

GSKClinicalSupportHD@gsk.com442089904466

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026