Chronic Hepatitis C InfectionPhase 1NCT04318379
Therapeutic Hepatitis C Virus Vaccine
A Phase 1 study testing HCVax in people with Chronic Hepatitis C Infection, run by GeneCure Biotechnologies at 1 site in United States.
Trial summary
GC002 is a Phase I trial to evaluate the safety and the immune responses of a lentiviral based HCV immunotherapy (HCVax™) in chronic HCV patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis C Infection
- What is being tested?
- HCVax
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2021to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Documentation of chronic hepatitis C infection based on serum positivity for HCV RNA for at least 6 months interval. HCV genotype will be recorded. All genotypes will be eligible.
- Patients who are not under DAA treatment.
- Liver fibrosis (by Metavir stage F1 or F0) within one year of the screening visit, documenting extent of liver disease consistent with chronic hepatitis C with evidence of inflammation and/or fibrosis. Fibrosis scaling is based on an ultrasound based elastography (FibroScan, Echosen, Paris France) with cutoff of 7.5 kPa or liver biopsy.
- Screening laboratory values within institutional normal range, with the exception of liver enzymes ≤ 3 ULN and bilirubin <1.5 ULN, or judged to be not clinically significant by clinical investigator.
- Ability and willingness of subject to give written informed consent.
- Negative pregnancy test on the day prior to each vaccination.
- Willingness to use adequate contraception by study participants. Subjects must agree not to participate in a conception process (e.g., active attempts to become pregnant or to impregnate, sperm donation, or in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, subjects must use a form of contraception as listed below while on study vaccine and for 60 days after stopping study vaccine. Women without reproductive potential (i.e., have reached menopause or undergone hysterectomy, bilateral oophorectomy, or tubal ligation) or women whose male partner has undergone successful vasectomy with documented azoospermia or has documented azoospermia for any other reason, are eligible without requiring the use of contraception.
Who cannot join
- History of decompensated liver disease, including but not restricted to, portal hypertension as manifested by a known history of gastroesophageal varices, variceal bleeding, ascites or encephalopathy, histopathologic or clinical evidence of cirrhosis, hepatocellular carcinoma, or renal impairment consistent with hepatorenal syndrome; history of significant other non-HCV chronic liver disease, i.e. alcoholic hepatitis, autoimmune hepatitis.
- History of hematologic disease (e.g., cryoglobulinemia, lymphoma), renal disease, dermatologic disease (e.g., lichen planus, porphyria cutanea tarda).
- Seropositive for hepatitis B surface antigen (HBsAg) or HIV-1 antibody.
- Autoimmune diseases or clinically serious cardiac, pulmonary, gastrointestinal, hepatic, renal or neurologic disease, which in the opinion of the investigator will compromise ability to participate in the study.
- Previous receipt of any HCV experimental vaccine.
- Pregnancy and breast-feeding.
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- Prior or current systemic cancer chemotherapy.
- Investigational agents and immunomodulators (cyclosporine, hematological growth factors, systemic corticosteroids, interleukins or interferons) within 90 days prior to study entry. NOTE: Subjects may not be on antiretroviral agents not yet approved by the FDA as part of a clinical trial or expanded access program.
- Anaphylaxis or allergy to vaccine components.
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Any other serious diseases other than HCV infection including current or recent (within 5 years) cancers.
- Liver fibrosis with Metavir stage F2 or above.
- Subjects with diabetes mellitus, who are at higher risk for more rapid progression of fibrosis.
- Subjects who are immunocompromised or immunosuppressed due to disease or medications.
- Subjects with any laboratory abnormalities Grade 3 or greater.
- Women who are lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University, Medical Center
Richmond, Virginia, 23298
Richard Sterling, Dr., 804-828-4060, richard.sterling@vcuhealth.org
Clinical Research Coordinator, 804-828-2988, paula.smith@vcuhealth.org
About this study
Official title: A Phase I Trial of an Immunotherapy (HCVax™) in Chronic Hepatitis C Infected Patients
GC002 is a Phase I trial to evaluate the safety and the immune responses of a lentiviral based HCV immunotherapy (HCVax™) in chronic HCV patients.
Read the detailed description
GC002 is a Phase I trial to evaluate the safety and the immune responses of a lentiviral based HCV immunotherapy (HCVax™) in chronic HCV patients. Chronic HCV patients will be enrolled sequentially into low dose and high dose groups. Following the vaccination subjects who received at least one vaccination will be followed up for safety and immunological response through week 28. All vaccine recipients will take part in a long-term safety follow-up for 6 months following the completion of the vaccine series to assess delayed adverse events.
Vaccination will first start at low dose. The investigators will enroll low dose group first. Two subjects will be staggering enrolled every 2 weeks. Following the assessment and review of prior vaccinations, if no vaccine definitely or probably-related severe adverse event (grade 3 or above) or SAE occurs the vaccination schedule for low dose and high dose will continue until complete enrollment.
Each subject will receive HCVax™ vaccine at 0, 8, 16 weeks through subcutaneous route. Following vaccination subjects will have clinical, immunological and virologic assessments throughout the 28-week study.
- Conditions
- Chronic Hepatitis C Infection
- Being tested
- HCVax
- Keywords
- Therapeutic HCV vaccine, HCV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCVaxBiological
HCVax is a lentiviral vector encoding several HCV antigens
| Study group | Role | What they receive |
|---|---|---|
| Low dose group | Experimental | Chronic HCV patients. Fifteen subjects will receive 1.0 ml of low dose vaccine at weeks 0, 8 and 16 through subcutaneous route. Receives: Biological: HCVax |
| High dose group | Experimental | Chronic HCV patients. Fifteen subjects will receive 1.0 ml of high dose vaccine at weeks 0, 8 and 16 through subcutaneous route. Receives: Biological: HCVax |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of a therapeutic HCV vaccine in chronic HCV patients
Frequency and severity of adverse events, laboratory abnormalities, local and systemic reactogenicity signs and symptoms following vaccinations.
Measured: 40 weeks
Secondary outcomes (2)
To evaluate the immunogenicity of a therapeutic HCV vaccine in chronic HCV patients
Magnitude of IFN-γ \& IL-2 producing CD4+ and CD8+ T cells to HCV core peptides pools at weeks 8, 16, and 24.
Measured: 40 weeks
Virologic response
Sustained viral response (SVR) will be defined as negative HCV RNA result using an assay that has sensitivity of 25 IU or less per milliliter at 12 weeks after the end of vaccination.
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start20 Apr 2021
- Primary completionFeb 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis C InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GeneCure Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318379
- Sponsor's protocol ID
- GC002
- Status last verified
- Sep 2021
- First submitted
- 18 Mar 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Final data will be published
Publications
Tung FY, Tung JK, Pallikkuth S, Pahwa S, Fischl MA. A therapeutic HIV-1 vaccine enhances anti-HIV-1 immune responses in patients under highly active antiretroviral therapy. Vaccine. 2016 Apr 27;34(19):2225-32. doi: 10.1016/j.vaccine.2016.03.021. Epub 2016 Mar 19.
PubMed 27002500
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of an Immunotherapy (HCVax™) in Chronic Hepatitis C Infected Patients
- ClinicalTrials.gov ID
- NCT04318379
- Acronym / sponsor ID
- GC002
- Conditions
- Chronic Hepatitis C Infection
- Keywords
- Therapeutic HCV vaccine, HCV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- GeneCure BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
GC002 is a Phase I trial to evaluate the safety and the immune responses of a lentiviral based HCV immunotherapy (HCVax™) in chronic HCV patients.
Detailed description
GC002 is a Phase I trial to evaluate the safety and the immune responses of a lentiviral based HCV immunotherapy (HCVax™) in chronic HCV patients. Chronic HCV patients will be enrolled sequentially into low dose and high dose groups. Following the vaccination subjects who received at least one vaccination will be followed up for safety and immunological response through week 28. All vaccine recipients will take part in a long-term safety follow-up for 6 months following the completion of the vaccine series to assess delayed adverse events.
Vaccination will first start at low dose. The investigators will enroll low dose group first. Two subjects will be staggering enrolled every 2 weeks. Following the assessment and review of prior vaccinations, if no vaccine definitely or probably-related severe adverse event (grade 3 or above) or SAE occurs the vaccination schedule for low dose and high dose will continue until complete enrollment.
Each subject will receive HCVax™ vaccine at 0, 8, 16 weeks through subcutaneous route. Following vaccination subjects will have clinical, immunological and virologic assessments throughout the 28-week study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose group | Experimental | Biological: HCVaxChronic HCV patients. Fifteen subjects will receive 1.0 ml of low dose vaccine at weeks 0, 8 and 16 through subcutaneous route. |
| High dose group | Experimental | Biological: HCVaxChronic HCV patients. Fifteen subjects will receive 1.0 ml of high dose vaccine at weeks 0, 8 and 16 through subcutaneous route. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Documentation of chronic hepatitis C infection based on serum positivity for HCV RNA for at least 6 months interval. HCV genotype will be recorded. All genotypes will be eligible.
- Patients who are not under DAA treatment.
- Liver fibrosis (by Metavir stage F1 or F0) within one year of the screening visit, documenting extent of liver disease consistent with chronic hepatitis C with evidence of inflammation and/or fibrosis. Fibrosis scaling is based on an ultrasound based elastography (FibroScan, Echosen, Paris France) with cutoff of 7.5 kPa or liver biopsy.
- Screening laboratory values within institutional normal range, with the exception of liver enzymes ≤ 3 ULN and bilirubin <1.5 ULN, or judged to be not clinically significant by clinical investigator.
- Ability and willingness of subject to give written informed consent.
Key exclusion criteria (16 listed)
- History of decompensated liver disease, including but not restricted to, portal hypertension as manifested by a known history of gastroesophageal varices, variceal bleeding, ascites or encephalopathy, histopathologic or clinical evidence of cirrhosis, hepatocellular carcinoma, or renal impairment consistent with hepatorenal syndrome; history of significant other non-HCV chronic liver disease, i.e. alcoholic hepatitis, autoimmune hepatitis.
- History of hematologic disease (e.g., cryoglobulinemia, lymphoma), renal disease, dermatologic disease (e.g., lichen planus, porphyria cutanea tarda).
- Seropositive for hepatitis B surface antigen (HBsAg) or HIV-1 antibody.
- Autoimmune diseases or clinically serious cardiac, pulmonary, gastrointestinal, hepatic, renal or neurologic disease, which in the opinion of the investigator will compromise ability to participate in the study.
- Previous receipt of any HCV experimental vaccine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCVaxHCVax is a lentiviral vector encoding several HCV antigens | Biological | High dose group, Low dose group |
Primary outcome
To evaluate the safety of a therapeutic HCV vaccine in chronic HCV patients
Time frame: 40 weeks
Frequency and severity of adverse events, laboratory abnormalities, local and systemic reactogenicity signs and symptoms following vaccinations.
2 secondary outcomes
To evaluate the immunogenicity of a therapeutic HCV vaccine in chronic HCV patients
Time frame: 40 weeks
Virologic response
Time frame: 40 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 27002500Tung FY, Tung JK, Pallikkuth S, Pahwa S, Fischl MA. A therapeutic HIV-1 vaccine enhances anti-HIV-1 immune responses in patients under highly active antiretroviral therapy. Vaccine. 2016 Apr 27;34(19):2225-32. doi: 10.1016/j.vaccine.2016.03.021. Epub 2016 Mar 19.
- Individual participant dataSharing planned: No. Final data will be published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HCVax in people with Chronic Hepatitis C Infection, run by GeneCure Biotechnologies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank Tung, Ph.D (7702637508, frank@genecure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of a therapeutic HCV vaccine in chronic HCV patients (time frame: 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04318379, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.