Hepatitis B Clinical Trial
Official title:
Study to Evaluate the Induction of HBV Virus Neutralizing Antibodies in Healthy Vaccine Naive Adults and Non-responders and in Patients Chronically Infected With HBV Using VVX001
The Study will evaluate the effects of VVX001, a novel vaccine for hepatitis B, to - elicit a robust protective IgG immune response in vaccine naive subjects - in subjects who failed to demonstrate seroconversion after treatment with a licensed hepatitis B vaccine and - in patients chronically infected with HBV.
Status | Recruiting |
Enrollment | 84 |
Est. completion date | December 31, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Cohort 1: hepatits B vaccine naive subjects Seronegative for anti-HBs and anti-HBc antibodies and for HBs Antigen - Cohort 2: Subjects who failed to develop a protective immune response upon standard vaccination with a licensed hepatitis B vaccine (<10 IU/L anti HbS antibodies) Seronegative for anti-HbS (<10 IU/L) and anti-HBc antibodies and for HbSAg - Cohort 3: Parameters confirmed at screening during the past 12 months 1. HBeAg negative; 2. HbSAg positive at screening <3000 IU/ml; 3. HBV viral load <2000 IU/ml 4. ALT Levels =ULN at screening - Cohort 4a: Parameters confirmed at screening during the last 12 months 1. HBeAg negative; 2. HbSAg positive <1000 IU/ml 3. HBV DNA not detectable for at least 2 years 4. History of nucleos(t)die Treatment for at least 3 years 5. Willingness to discontinue NUC treatment during study 6. ALT levels =ULN at screening - Cohort 4b: in addition to cohort 4a: 1. willingness to discontinue NUC treatment 6 weeks before entering the Study 2. ALT Levels =ULN 6 weeks before entering the study and - 5x ULN at screening Exclusion Criteria: - Pregnant or breast-feeding females, adequate contraception required during the treatment phase - History of grass pollen allergy - Co-infection with HCV, HDV, HIV - History of auto-immune hepatitis - Elevated Levels of Alpha-Fetoprotein (AFP) >100 ng/ml - Documented history of decompensated liver disease (albumin <3.5 g/dl and bilirubin >1.3 mg/dl) - Autoimmune disorders, transplant recipients, use of immunosuppressive or immune modulating agents - Oral corticosteroids of 20 mg/week within the past 4 weeks prior to screening - History of treatment with PEG-IFN of IFN for at least 1 year prior to screening - History of evidence or conditions associated with chronic liver disease - Acute fever at time of enrolment - History of alcohol abuse - Planned administration of a vaccine not foreseen by study protocol in the period starting 30 days before first product administration and during the entire study period with exception of influenza vaccine - History of Cancer - Other severe co-morbid conditions and concurrent medication making the subject unsuitable for participation - blood or plasma donation within 1 month of study enrolement and during the course of the study - For all patients with chronic HBV infection: 1. Total bilirubin >2x ULN confirmed by repeat testing within 2 weeks, unless historical documentation of Gilbert's syndrome 2. Documented or suspected hepatocelluar carcinoma 3. Presence of cholangitis, cholecystitis or bile duct obstruction 4. Liver cirrhosis assessed by fibroscan with elastography <9kPa within the previous 12 months and FIB-score <3.2 at study entry |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Graz | Graz | |
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Viravaxx AG | Gouya Insights, KKS MedUni Vienna |
Austria,
Cornelius C, Schöneweis K, Georgi F, Weber M, Niederberger V, Zieglmayer P, Niespodziana K, Trauner M, Hofer H, Urban S, Valenta R. Immunotherapy With the PreS-based Grass Pollen Allergy Vaccine BM32 Induces Antibody Responses Protecting Against Hepatitis B Infection. EBioMedicine. 2016 Sep;11:58-67. doi: 10.1016/j.ebiom.2016.07.023. Epub 2016 Aug 8. — View Citation
Tulaeva I, Cornelius C, Zieglmayer P, Zieglmayer R, Schmutz R, Lemell P, Weber M, Focke-Tejkl M, Karaulov A, Henning R, Valenta R. Quantification, epitope mapping and genotype cross-reactivity of hepatitis B preS-specific antibodies in subjects vaccinated with different dosage regimens of BM32. EBioMedicine. 2020 Sep;59:102953. doi: 10.1016/j.ebiom.2020.102953. Epub 2020 Aug 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse events | Frequency, intensity and relatedness of adverse events | up to 52 weeks | |
Primary | PreS specific IgG antibodies | Titer of PreS specific IgG antibodies | 4 weeks after the last injection of study drug | |
Secondary | PreS specific IgG, IgG1 and IgG4 antibodies | Titers of PreS specific IgG, IgG1 and IgG4 antibodies | 4 weeks and 6 months after the last injection of study drug | |
Secondary | HbSAg specific antibodies | Titers of HbSAg specific antibodies | 4 weeks and 6 months after the last injection of study drug | |
Secondary | Suppression of HBV infection | Suppression of HBV infection in HepG2-NTCP cells using HBV strain D3 in cell culture with patient sera | 4 weeks and 6 months after the last injection of study drug | |
Secondary | T cell proliferation | Proliferation of PreS specific CD4 and CD8 T cells | 4 weeks and 6 months after the last injection of study drug | |
Secondary | HbSAg titers | HbS Antigen titers will be measured in chronically infected patients | 4 weeks and 6 months after the last injection of study drug | |
Secondary | HBV DNA load | HBV DNA load will be measured by PCR in chronically infected patients | 4 weeks and 6 months after the last injection of study drug | |
Secondary | HBVcrAg titers | HBVcrAG titers will be measured in chronically infected patients | 4 weeks and 6 months after the last injection of study drug |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01182311 -
Duration of Long-term Immunity After Hepatitis B Virus Immunization
|
||
Completed |
NCT04971928 -
Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment
|
Phase 1 | |
Completed |
NCT03285620 -
A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants
|
Phase 1 | |
Completed |
NCT01884415 -
Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis
|
Phase 3 | |
Recruiting |
NCT05404919 -
Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates
|
Phase 2 | |
Completed |
NCT02153320 -
Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers
|
Phase 1 | |
Completed |
NCT00352963 -
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).
|
Phase 3 | |
Completed |
NCT03567382 -
Arresting Vertical Transmission of Hepatitis B Virus
|
Phase 4 | |
Not yet recruiting |
NCT04056728 -
A Phase IV Study to Assess the Safety of EupentaTM Inj
|
Phase 4 | |
Not yet recruiting |
NCT03604016 -
Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
|
Phase 4 | |
Completed |
NCT00753649 -
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
|
Phase 4 | |
Recruiting |
NCT03027258 -
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
|
N/A | |
Completed |
NCT02540538 -
Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders
|
Phase 1 | |
Terminated |
NCT02604199 -
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection
|
Phase 2 | |
Completed |
NCT02421666 -
A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV
|
N/A | |
Completed |
NCT02169674 -
Hepatitis B Booster Study in Adolescence
|
Phase 4 | |
Completed |
NCT01917357 -
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
|
Phase 3 | |
Completed |
NCT01368497 -
Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection
|
Phase 3 | |
Completed |
NCT01732354 -
Study for Consolidation Period of Chronic Hepatitis B
|
||
Recruiting |
NCT01462981 -
Cohort of Hepatitis B Research of Amsterdam
|
N/A |