A Study of a New Candidate Vaccine Against Hepatitis C Virus (HCV)

ReiThera

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Biological: AdCh3NSmut; Ad6NSmut; Biological: Ad6NSmut; AdCh3NSmut

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01070407

2007-004259-12 (EudraCT Number)

HCV001

GTAC144 (Other Identifier)

Details and patient eligibility

About

HCV001 is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine against Hepatitis C virus (HCV). The vaccine is based on the sequential delivery, by intramuscular route, of two different adenoviral vectors, of human and chimpanzee origin respectively, bearing the same genetic information for HCV antigens (NS region).

The two recombinant vectors, called Ad6NSmut and AdCh3NSmut, are weakened and unable to multiply within the body; they are designed to induce an immune response against HCV proteins. Although Ad6NSmut and AdCh3NSmut have never been given to humans before this trial, promising results have been obtained in non-human studies.

The HCV001 study is designed to explore different prime-boost regimes concerning dose, order and interval of administration of Ad6NSmut and AdCh3NSmut.

Enrollment: 41 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The volunteer must satisfy all the following criteria to be eligible for the study:

• Healthy adults aged 18 to 50 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
• Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
• For females only, willingness to practice continuous effective barrier contraception during the study and a negative pregnancy test on the day(s) of vaccination
• For men to use barrier contraception until three months after the last vaccination
• Agreement to refrain from blood donation during the course of the study
• Written informed consent

Exclusion criteria

The volunteer may not enter the study if any of the following 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
• Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
• 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)
• History of serious psychiatric condition
• Any other serious chronic illness requiring hospital specialist supervision
• Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
• Suspected or known injecting drug abuse
• Seropositive for hepatitis B surface antigen (HBsAg)
• Seropositive for HIV (antibodies to HIV) at screening
• Seropositive for hepatitis C virus (antibodies to HCV) at screening
• Seropositive for simian adenovirus 3 (antibodies to AdCh3) at titres >200, at screening
• Seropositive for human adenovirus 6 (antibodies to Ad6) at titres >200, at screening
• Any other significant disease, disorder or finding, which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate in the study
• Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
• 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.
• Vulnerable subjects (according to the ICH E6 GCP)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

41 participants in 9 patient groups

Arm A, group 1

Experimental group

Description:

4 volunteers

Treatment:

Biological: Ad6NSmut; AdCh3NSmut

Biological: Ad6NSmut; AdCh3NSmut

Biological: Ad6NSmut; AdCh3NSmut

Biological: Ad6NSmut; AdCh3NSmut

Arm A, group 2

Experimental group

Description:

4 volunteers

Treatment:

Biological: Ad6NSmut; AdCh3NSmut

Biological: Ad6NSmut; AdCh3NSmut

Biological: Ad6NSmut; AdCh3NSmut

Biological: Ad6NSmut; AdCh3NSmut

Arm A, group 3

Experimental group

Description:

5 volunteers

Treatment:

Biological: Ad6NSmut; AdCh3NSmut

Biological: Ad6NSmut; AdCh3NSmut

Biological: Ad6NSmut; AdCh3NSmut

Biological: Ad6NSmut; AdCh3NSmut

Arm B, group 5

Experimental group

Description:

4 volunteers

Treatment:

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Arm B, group 6

Experimental group

Description:

4 volunteers

Treatment:

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Arm B, group 7

Experimental group

Description:

5 volunteers

Treatment:

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Arm C, group 9

Experimental group

Description:

5 volunteers

Treatment:

Biological: Ad6NSmut; AdCh3NSmut

Biological: Ad6NSmut; AdCh3NSmut

Biological: Ad6NSmut; AdCh3NSmut

Biological: Ad6NSmut; AdCh3NSmut

Arm C, group 10

Experimental group

Description:

5 volunteers

Treatment:

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Arm C, group 11

Experimental group

Description:

4 volunteers

Treatment:

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut

Biological: AdCh3NSmut; Ad6NSmut