Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT01296451
Eligibility Criteria:
Inclusion Criteria:
The healthy volunteers must satisfy all the following inclusion criteria to be eligible for the study (group A1 or A2):
* Healthy adults aged 18 to 55 years (inclusive)
* Resident in or near the trial sites for the duration of the vaccination study
* Able and willing (in the Investigator's opinion) to comply with all study requirements
* For women of child bearing potential, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of vaccination
* Men, including those with pregnant partners, should use barrier contraception until 3 months after the last vaccination
* Written informed consent
The patients with HCV in Groups B1, B2 and C1 must satisfy all the following inclusion criteria to be eligible for the study:
* HCV infected with genotype-1 infection (any viral load)
* Patients must not be currently receiving any treatment for HCV infection.
* Adults aged 18 to 64 years (inclusive)
* Resident in or near the trial sites for the duration of the vaccination study
* Able and willing (in the Investigator's opinion) to comply with all study requirements
* Liver transaminases may be within normal limits or elevated.
* For men in Arm B, including those with pregnant partners, a willingness to use barrier contraception until six months after completing treatment with IFN/ribavirin
* For women in Arm B, of child bearing potential, a willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of vaccination.
* For men in arm C, including those with pregnant partners, a willingness to use barrier contraception until three months after the last vaccination
* Written informed consent
* Patients with HCV in groups B1 and B2 must be treatment naïve to previous IFN and ribavirin combination therapy. They may be included if they have been previously treated with interferon monotherapy but relapsed after treatment.
* Patients with HCV in groups C1 may be treatment naïve, or have been previously treated with interferon monotherapy or interferon and ribavirin therapy and relapsed after treatment
Exclusion Criteria:
The subjects (both healthy individuals or patients) may not enter the study if any of the following exclusion criteria apply:
* Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
* Prior receipt of a recombinant simian or human adenoviral vaccine
* Clinical, biochemical (abnormal liver synthetic dysfunction defined by an elevated blood prothrombin time or a low blood albumin level), ultrasonographic, or liver biopsy (histology) evidence of cirrhosis or portal hypertension
* Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g., Kathon
* History of clinically significant contact dermatitis
* Any history of anaphylaxis in reaction to vaccination
* Pregnancy, lactation or willingness/intention to become pregnant during the study
* History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
* Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
* Current suspected or known injecting drug abuse
* Seropositive for hepatitis B surface antigen (HBsAg)
* Seropositive for HIV (antibodies to HIV) at screening
* Any other significant disease, disorder or finding, which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or may influence the result of the study, or the patient's ability to participate in the study
* Any other finding which in the opinion of the investigators would significantly increase the risk of having an adverse outcome from participating in the protocol
* Individuals who have had a temperature \>38°C in the 3 days preceding vaccination.
* Patients likely to have been infected with HCV within the last 12 months
In addition to the above listed exclusion criteria:
Patients with HCV may not enter arms B1 and B2 of the study if any of the following exclusion criteria applies:
* Patients are non-responders to previous IFN-alpha monotherapy
* Patients who received IFN-alpha and ribavirin or PEG-IFN and ribavirin in the past and who were non-responders or who relapsed during or after therapy
* Patients with a known allergy to ribavirin or interferon-alpha
* Haemoglobin less than 10g/dl
* Severe neutropenia or thrombocytopenia
* Patients who have had a heart attack or who have suffered from any other severe heart disease in the last 6 months
* Patients with haemoglobinopathies
* Autoimmune hepatitis
* Autoimmune disease
* History of organ transplantation
* Uncontrolled seizures
* Uncontrolled severe psychiatric conditions
Patients with HCV may not enter arm C if they were previous non-responders to interferon monotherapy, or interferon and ribavirin combination therapy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01296451
Study Brief:
Protocol Section:
NCT01296451