Phase I Study of INO-1800 With or Without INO-9112 + EP in Chronic Hepatitis B Subjects
- Conditions
- Hepatitis B
- Interventions
- Biological: INO-1800Drug: Nucleos(t)ide Analogue TreatmentBiological: INO-9112
- Registration Number
- NCT02431312
- Lead Sponsor
- Inovio Pharmaceuticals
- Brief Summary
This was an open-label study that evaluated the safety, tolerability, and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding Hepatitis B surface antigen \[HBsAg\] and Hepatitis B core antigen \[HBcAg\]) and INO-9112 (DNA plasmid encoding human interleukin 12) delivered by electroporation (EP) in 90 (ninety) nucleos(t)ide analogue treated participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Group A: low dose, standard regimen INO-1800 Participants received 3 or 4 doses of 0.3 mg INO-1800 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment. Group A: low dose, standard regimen Nucleos(t)ide Analogue Treatment Participants received 3 or 4 doses of 0.3 mg INO-1800 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment. Group A: mid dose, standard regimen INO-1800 Participants received 3 or 4 doses of 2 mg INO-1800 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment. Group A: mid dose, standard regimen Nucleos(t)ide Analogue Treatment Participants received 3 or 4 doses of 2 mg INO-1800 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment. Group A: high dose, standard regimen INO-1800 Participants received 3 or 4 doses of 9 mg INO-1800 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment. Group A: high dose, standard regimen Nucleos(t)ide Analogue Treatment Participants received 3 or 4 doses of 9 mg INO-1800 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment. Group B: mid dose, standard regimen INO-1800 Participants received 3 or 4 doses of 2 mg INO-1800 + 0.25 mg INO-9112 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment. Group B: mid dose, standard regimen INO-9112 Participants received 3 or 4 doses of 2 mg INO-1800 + 0.25 mg INO-9112 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment. Group B: mid dose, standard regimen Nucleos(t)ide Analogue Treatment Participants received 3 or 4 doses of 2 mg INO-1800 + 0.25 mg INO-9112 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment. Group B: high dose, standard regimen INO-1800 Participants received 3 or 4 doses of 9 mg INO-1800 + 0.25 mg INO-9112 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment. Group B: high dose, standard regimen INO-9112 Participants received 3 or 4 doses of 9 mg INO-1800 + 0.25 mg INO-9112 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment. Group B: high dose, standard regimen Nucleos(t)ide Analogue Treatment Participants received 3 or 4 doses of 9 mg INO-1800 + 0.25 mg INO-9112 delivered by EP in a standard regimen while continuing treatment with nucleos(t)ide analogue treatment. Active Control: nucleos(t)ide analogue treatment Nucleos(t)ide Analogue Treatment Participants continued treatment with nucleos(t)ide analogue treatment.
- Primary Outcome Measures
Name Time Method Safety Assessment (Composite of multiple measures: pain (VAS), adverse events, lab abnormalities, changes in vital signs) Signing of ICF through up to 76 weeks following the first dose Composite outcome measure consisting of multiple measures, including:
1. Local pain immediately after Study Treatment/EP and at select times using a visual analog scale (VAS) from 0 to 10, with 0 representing "No Pain" and 10 representing "Worst Pain"
2. Frequency and severity of local and systemic events for at least 7 days after Study Treatment/EP
3. Frequency and severity of laboratory abnormalities
4. Frequency and severity of all adverse events
5. Changes in vital signs
- Secondary Outcome Measures
Name Time Method Viral/Antiviral Assessment Screening and/or first dose and select points up to 76 weeks after the first dose Composite outcome measure consisting of multiple measures, including:
1. Evaluate effect on HBsAg kinetics as measured in the quantitative HBsAg assay
2. Evaluate effect on maintenance of HBV DNA suppression (\< 90 IU/ml) as measured in the quantitative viral load assayImmunogenicity Assessment Baseline (screening and first dose) and select points up to 76 weeks after the first dose Composite outcome measure consisting of multiple measures, including
1. Breadth and Magnitude of antigen specific cellular immune responses
* Interferon-ɣ ELISpot
* Flow Cytometry for T-cell activation, cytolytic phenotype, memory phenotype
2. Breadth and Magnitude of antigen specific ELISA
Trial Locations
- Locations (22)
Chang Gung Memorial Hospital
🇨🇳Linkou, Taoyuan County, Taiwan
Srinagarind Hospital
🇹🇭Khon Kaen, Muang District, Thailand
Nepean Hospital
🇦🇺Kingswood, New South Wales, Australia
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Singapore General Hospital
🇸🇬Singapore, Singapore
Mount Sinai - PRIME
🇺🇸New York, New York, United States
The Medical City
🇵🇭Pasig City, Philippines
Maharaj Nakorn Chiang Mai Hospital
🇹🇭Tha Muang, Chiang Mai, Thailand
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Auckland City Hospital
🇳🇿Auckland, New Zealand
Siriraj Hospital, Mahidol University
🇹🇭Bangkoknoi, Bangkok, Thailand
Research and Education, Inc.
🇺🇸San Diego, California, United States
UC Physicians Company, LLC/Division of Digestive Diseases
🇺🇸Cincinnati, Ohio, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
University of Miami Schiff Center for Liver Disease
🇺🇸Miami, Florida, United States
Northwell Health
🇺🇸Manhasset, New York, United States
Philadelphia VA Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Harbourview Medical Center
🇺🇸Seattle, Washington, United States
Mater Adult Hospital
🇦🇺South Brisbane, Queensland, Australia
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
The University of Hong Kong
🇭🇰Hong Kong, Hong Kong