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

This study has been completed.
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
ReiThera Srl
ClinicalTrials.gov Identifier:
NCT01070407
First received: February 16, 2010
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Biological: Ad6NSmut; AdCh3NSmut
Biological: AdCh3NSmut; Ad6NSmut
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase I Study to Assess the Safety and Immunogenicity of New Hepatitis C Virus Vaccine Candidates AdCh3NSmut and Ad6NSmut

Resource links provided by NLM:


Further study details as provided by ReiThera Srl:

Primary Outcome Measures:
  • To assess the safety of AdCh3NSmut and Ad6NSmut, when administered in a prime/boost regimen to healthy volunteers. The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. [ Time Frame: Different time points depending on the study groups with a 6-months follow-up after last vaccination for all groups ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the immunogenicity of AdCh3NSmut and Ad6NSmut, when administered in prime/boost regimen to healthy volunteers. The specific endpoint of cellular immune response will be collected via IFNγ ELIspot assay and other exploratory immunological tests. [ Time Frame: Different time points depending on the study groups with a 6-months follow-up after last vaccination for all groups ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2007
Study Completion Date: February 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A, group 1
4 volunteers
Biological: Ad6NSmut; AdCh3NSmut
2 doses Ad6NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
Experimental: Arm A, group 2
4 volunteers
Biological: Ad6NSmut; AdCh3NSmut
2 doses Ad6NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
Experimental: Arm A, group 3
5 volunteers
Biological: Ad6NSmut; AdCh3NSmut
2 doses Ad6NSmut 2.5 x 10^10vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
Experimental: Arm B, group 5
4 volunteers
Biological: AdCh3NSmut; Ad6NSmut
2 doses AdCh3NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
Experimental: Arm B, group 6
4 volunteers
Biological: AdCh3NSmut; Ad6NSmut
2 doses AdCh3NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
Experimental: Arm B, group 7
5 volunteers
Biological: AdCh3NSmut; Ad6NSmut
2 doses AdCh3NSmut 2.5 x 10^10vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
Experimental: Arm C, group 9
5 volunteers
Biological: Ad6NSmut; AdCh3NSmut
1 dose Ad6NSmut 2.5 x 10^10vp at week 0 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 8.
Experimental: Arm C, group 10
5 volunteers
Biological: AdCh3NSmut; Ad6NSmut
1 dose AdCh3NSmut 2.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 8.
Experimental: Arm C, group 11
4 volunteers
Biological: AdCh3NSmut; Ad6NSmut
1 dose AdCh3NSmut 7.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 7.5 x 10^10vp at week 8.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070407

Locations
United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Wellcome Clinical Research Facility, Queen Elizabeth's Hospital, University Hospital Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B15 2TH
Sponsors and Collaborators
ReiThera Srl
University of Oxford
Investigators
Study Chair: Paul Klenerman, Professor University of Oxford, UK
Principal Investigator: David Adams, Professor University of Birmingham, UK
  More Information

Additional Information:
No publications provided

Responsible Party: ReiThera Srl
ClinicalTrials.gov Identifier: NCT01070407     History of Changes
Other Study ID Numbers: HCV001, 2007-004259-12, GTAC144
Study First Received: February 16, 2010
Last Updated: October 7, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Department of Health
Italy: National Institute of Health
Italy: Ethics Committee

Keywords provided by ReiThera Srl:
Hepatitis C virus
HCV
Adenovirus
Vaccine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014