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

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Ad6NSmut; AdCh3NSmut

AdCh3NSmut; Ad6NSmut

Ad6NSmut; AdCh3NSmut

AdCh3NSmut; Ad6NSmut

About this trial

This is an interventional prevention trial for Hepatitis C focused on measuring Hepatitis C virus, HCV, Adenovirus, Vaccine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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)

Sites / Locations

Centre for Clinical Vaccinology and Tropical Medicine
Wellcome Clinical Research Facility, Queen Elizabeth's Hospital, University Hospital Birmingham NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Arm Label

Arm A, group 1

Arm A, group 2

Arm A, group 3

Arm B, group 5

Arm B, group 6

Arm B, group 7

Arm C, group 9

Arm C, group 10

Arm C, group 11

Arm Description

4 volunteers

5 volunteers

4 volunteers

5 volunteers

4 volunteers

Outcomes

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.

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.

Full Information

NCT ID

NCT01070407

First Posted

February 16, 2010

Last Updated

April 22, 2015

Sponsor

ReiThera Srl

Collaborators

University of Oxford

1. Study Identification

Unique Protocol Identification Number

NCT01070407

Brief Title

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

Official Title

A Phase I Study to Assess the Safety and Immunogenicity of New Hepatitis C Virus Vaccine Candidates AdCh3NSmut and Ad6NSmut

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ReiThera Srl

Collaborators

University of Oxford

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

Keywords

Hepatitis C virus, HCV, Adenovirus, Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A, group 1

Arm Type

Experimental

Arm Description

4 volunteers

Arm Title

Arm A, group 2

Arm Type

Experimental

Arm Description

4 volunteers

Arm Title

Arm A, group 3

Arm Type

Experimental

Arm Description

5 volunteers

Arm Title

Arm B, group 5

Arm Type

Experimental

Arm Description

4 volunteers

Arm Title

Arm B, group 6

Arm Type

Experimental

Arm Description

4 volunteers

Arm Title

Arm B, group 7

Arm Type

Experimental

Arm Description

5 volunteers

Arm Title

Arm C, group 9

Arm Type

Experimental

Arm Description

5 volunteers

Arm Title

Arm C, group 10

Arm Type

Experimental

Arm Description

5 volunteers

Arm Title

Arm C, group 11

Arm Type

Experimental

Arm Description

4 volunteers

Intervention Type

Biological

Intervention Name(s)

Ad6NSmut; AdCh3NSmut

Intervention Description

2 doses Ad6NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.

Intervention Type

Biological

Intervention Name(s)

Ad6NSmut; AdCh3NSmut

Intervention Description

2 doses Ad6NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.

Intervention Type

Biological

Intervention Name(s)

Ad6NSmut; AdCh3NSmut

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

AdCh3NSmut; Ad6NSmut

Intervention Description

2 doses AdCh3NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.

Intervention Type

Biological

Intervention Name(s)

AdCh3NSmut; Ad6NSmut

Intervention Description

2 doses AdCh3NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.

Intervention Type

Biological

Intervention Name(s)

AdCh3NSmut; Ad6NSmut

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Ad6NSmut; AdCh3NSmut

Intervention Description

1 dose Ad6NSmut 2.5 x 10^10vp at week 0 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 8.

Intervention Type

Biological

Intervention Name(s)

AdCh3NSmut; Ad6NSmut

Intervention Description

1 dose AdCh3NSmut 2.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 8.

Intervention Type

Biological

Intervention Name(s)

AdCh3NSmut; Ad6NSmut

Intervention Description

1 dose AdCh3NSmut 7.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 7.5 x 10^10vp at week 8.

Primary Outcome Measure Information:

Title

Time Frame

Different time points depending on the study groups with a 6-months follow-up after last vaccination for all groups

Secondary Outcome Measure Information:

Title

Time Frame

Different time points depending on the study groups with a 6-months follow-up after last vaccination for all groups

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Klenerman, Professor

Organizational Affiliation

University of Oxford, UK

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

David Adams, Professor

Organizational Affiliation

University of Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre for Clinical Vaccinology and Tropical Medicine

City

Oxford

State/Province

Oxfordshire

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

Facility Name

Wellcome Clinical Research Facility, Queen Elizabeth's Hospital, University Hospital Birmingham NHS Foundation Trust

City

Birmingham

State/Province

West Midlands

ZIP/Postal Code

B15 2TH

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

33317695

Citation

Alsaleh G, Panse I, Swadling L, Zhang H, Richter FC, Meyer A, Lord J, Barnes E, Klenerman P, Green C, Simon AK. Autophagy in T cells from aged donors is maintained by spermidine and correlates with function and vaccine responses. Elife. 2020 Dec 15;9:e57950. doi: 10.7554/eLife.57950.

Results Reference

derived

Links:

URL

http://www.okairos.com

Description

HCV001 Study sponsor web site

Learn more about this trial

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

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