Hepatitis CPhase 1NCT03688061
Class II Invariant Chain HCV Vaccine Study
A Phase 1 study testing ChAd3-hliNSmut and MVA-hliNSmut in people with Hepatitis C, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
The study is aimed at assessing the safety and immunogenicity of HCV prime-boost vaccinations ChAd3-hliNSmut and MVA-hliNSmut, administered intramuscularly in healthy volunteers and DAA treated patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- ChAd3-hliNSmut and MVA-hliNSmut
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 4 Dec 2017to 4 Aug 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged at least 18 years on the day of screening and no greater than 65 years on the day of the first vaccination
- Resident in or easy access to the trial site for the duration of the study
- Available for follow-up for the planned duration of the study
- Able and willing (in the CI'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 heterosexual females, willingness to practice continuous effective contraception from screening until 4 months after the last immunisation
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- All female volunteers must be willing to undergo urine pregnancy tests at the time points specified in the Schedule of Procedures and must have a negative pregnancy test on the day(s) of vaccination
- For sexually active men, willingness to use condoms from screening until 4 months after the last vaccination
- Agreement to refrain from blood donation during the course of the study
- In the opinion of the Chief Investigator or designee, the volunteer has understood the information provided. Written informed consent must be given before any study-related procedures are performed
- Willing to undergo HCV and HIV testing, counselling and receive test results
- Specific for Groups 1 and 2:
- Healthy males or females, as assessed by medical history, physical examination and laboratory tests
- Specific for Group 3:
- A previous diagnosis of chronic HCV infection (any HCV genotype) successfully treated with all oral DAA therapy.
- Minimum duration of six months between last dose of DAA treatment and planned vaccination date
- SVR 12 following last DAA treatment course
- Fibroscan score of <12.5kPa within 6 months of screening.
Who cannot join
- Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned used during the study period
- Prior receipt of a recombinant simian adenoviral vaccine
- Receipt of any investigational HCV vaccine within the last 6 years
- Administration of immunoglobulins and/or any blood products within the last three months preceding the planned administration of the vaccine candidate
- Receipt of live attenuated vaccine within the previous 60 days or planned receipt within 60 days after vaccination with the IMP
- Receipt of other vaccine, including influenza vaccine, within the previous 14 days or planned receipt within 14 days after vaccination with the IMP
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- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressive medication within the last 6 months (inhaled and topical steroids are allowed)
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
- Any history of anaphylaxis in reaction to vaccination
- Pregnancy, lactation or willingness/intention to become pregnant during the study
- Personal history of autoimmune disease
- History of major autoimmune disease in first degree relative, e.g. Type 1 diabetes, Graves' Disease, Systemic Lupus Erythematosus (SLE) or Spondyloarthropathy (AS).
- HLA type B27 positive individuals
- 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 current injecting drug use
- Seropositive for hepatitis B surface antigen (HBsAg)
- Any clinically significant acute or chronic medical condition that is considered unstable/progressive, or in the opinion of the Chief 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 test 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
- Vulnerable subjects (according to ICH GCP)
- Specific for groups 1 and 2:
- Previous HCV infection
- Reported current or previous high-risk behaviour for HCV infection (including IVDU)
- Seropositive for hepatitis C virus (antibodies to HCV) at screening
- Specific for group 3:
- Reported current high-risk behaviour for HCV infection (previous IVDU is not an exclusion criteria for this group)
- HCV RNA positive following DAA treatment
- Cirrhosis or severe fibrosis (Ishak 5 or 6) as previously defined by any of the following:
- Radiological findings on CT, MR or USS
- Abnormal biochemical parameters (PT, albumin and bilirubin)
- clinical signs of liver decompensation (ascites, varices, encephalopathy)
- Ishak score 5 on liver biopsy
- Fibroscan at any time point in the past >12.5kPa
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Centre for Cinical Vaccinology and Tropical Medicine, Univeristy of Oxford
Oxford, Oxfordshire, OX3 7LJ
Hepatology Clinical Trial Unit, John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: A Phase-I Dose-Escalation Study to Evaluate the Safety and Immunogenicity of Prime-Boost Immunisations With Candidate HCV Vaccines, ChAd3-hliNSMut and MVA-hliNSMut in Healthy Volunteers and Patients Previously Chronically Infected With HCV
The study is aimed at assessing the safety and immunogenicity of HCV prime-boost vaccinations ChAd3-hliNSmut and MVA-hliNSmut, administered intramuscularly in healthy volunteers and DAA treated patients.
Read the detailed description
Hepatitis C currently infects more than 180 million people worldwide and is associated with the development of liver cancer, liver failure and liver cirrhosis. Although drug treatments are available these are expensive and prolonged. Furthermore patients often only present to health care professionals at late stages when liver disease has already progressed. Therefore, vaccination remains the optimal method of preventing infection. To date this has proved extremely difficult due to the enormous variation in HCV strains around the world.
Researchers at the University of Oxford in collaboration with industry, have developed novel candidate vaccines against HCV ('NSmut'). These vaccines have been inserted into the carrier viruses Chimpanzee Adenovirus (ChAd) and modified vaccinia virus Ankara (MVA), both of which have excellent safety records. These vaccines have been given to hundreds of healthy volunteers and are now being tested for effectiveness.
In this study we are hoping to increase the immune response against the HCV virus. We will do this by inserting a gene in the vaccine (class-II invariant gene). In animal studies, this approach has been shown to be safe and to significantly to enhance the immune response against HCV.
During this study 15 healthy adults and 10 volunteers who were previously treated for HCV infection, aged 18-65 years, will receive either two intramuscular injections over a period of two months. All participants will be followed up for a further 6 months (12 visits in total) and will be asked to give a blood sample at each clinic visit.
The aims of the study are to assess the safety of the vaccine and to see if the vaccine can induce a strong immune response against the hepatitis C Virus.
- Conditions
- Hepatitis C
- Being tested
- ChAd3-hliNSmut, MVA-hliNSmut
- Keywords
- Hepatitis, Vaccine, Adenoviral-vector, human invariant chain
- Medical subject headings
- Hepatitis C, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAd3-hliNSmutBiological
Attenuated chimpanzee adenovirus (ChAd) vectored vaccine against HCV
MVA-hliNSmutBiological
Modified Vaccinia Ankara (MVA) vectored vaccine against HCV
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (low dose/healthy volunteers) | Experimental | 5 healthy volunteers receiving 1 dose ChAd3-hliNSmut (5x10*9 vp) IM at week 0 and 1 dose of MVA-hliNSmut (5 X10*7 pfu) IM at week 8 Receives: Biological: ChAd3-hliNSmut; Biological: MVA-hliNSmut |
| Group 2 (higher dose/healthy volunteers) | Experimental | 10 healthy volunteers receiving 1 dose ChAd3-hliNSmut (2.5 x10*10 vp) IM at week 0 and 1 dose of MVA-hliNSmut (2 X 10*8 pfu) IM at week 8 Receives: Biological: ChAd3-hliNSmut; Biological: MVA-hliNSmut |
| Group 3 (higher dose/HCV cured volunteers) | Experimental | 10 DAA treated volunteers (previously HCV positive) receiving 1 dose ChAd3-hliNSmut (2.5 x10*10 vp) IM at week 0 and 1 dose of MVA-hliNSmut (2 X10*8 pfu) IM at week 8 Receives: Biological: ChAd3-hliNSmut; Biological: MVA-hliNSmut |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of volunteers who develop a grade 3 local and systemic reactions
To evaluate the safety of administering HCV prime-boost vaccinations, ChAd3-hliNSmut and MVA-hilNSmut intramuscularly in healthy volunteers and DAA treated volunteers that were previously infected with HCV
Measured: Actively collected throughout the study until 6 months after the last vaccination
Secondary outcomes (1)
Proportion of volunteers who develop T cell responses to HCV epitopes, as determined by INF-gamma ELISpot assay
To assess the cellular immune response generated by HCV prime-boost vaccinations, ChAd3-hliNSmut and MVA-hliNSmut administered intramuscularly to healthy volunteers and DAA treated volunteers that were previously infected with HCV
Measured: Actively collected throughout the study until 6 months after the last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start4 Dec 2017
- Primary completion4 Aug 2019
- Study completion4 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Each group will be sequentially recruited over a period of two months to allow for safety review.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, ReiThera Srl, European Commission, GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Eleanor Barnes, Professor, Study chair, University of OxfordLucy Dorrell, Professor, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688061
- Sponsor's protocol ID
- PEACHI-03
- Other IDs
- 2016-000983-41, 2016
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2018
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-I Dose-Escalation Study to Evaluate the Safety and Immunogenicity of Prime-Boost Immunisations With Candidate HCV Vaccines, ChAd3-hliNSMut and MVA-hliNSMut in Healthy Volunteers and Patients Previously Chronically Infected With HCV
- ClinicalTrials.gov ID
- NCT03688061
- Acronym / sponsor ID
- PEACHI-03
- Conditions
- Hepatitis C
- Keywords
- Hepatitis, Vaccine, Adenoviral-vector, human invariant chain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, ReiThera Srl, European Commission, GlaxoSmithKline
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 4 Aug 2019 (actual)
- Study completion
- 4 Aug 2022 (actual)
- First posted
- 27 Sep 2018 (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.
The study is aimed at assessing the safety and immunogenicity of HCV prime-boost vaccinations ChAd3-hliNSmut and MVA-hliNSmut, administered intramuscularly in healthy volunteers and DAA treated patients.
Detailed description
Hepatitis C currently infects more than 180 million people worldwide and is associated with the development of liver cancer, liver failure and liver cirrhosis. Although drug treatments are available these are expensive and prolonged. Furthermore patients often only present to health care professionals at late stages when liver disease has already progressed. Therefore, vaccination remains the optimal method of preventing infection. To date this has proved extremely difficult due to the enormous variation in HCV strains around the world.
Researchers at the University of Oxford in collaboration with industry, have developed novel candidate vaccines against HCV ('NSmut'). These vaccines have been inserted into the carrier viruses Chimpanzee Adenovirus (ChAd) and modified vaccinia virus Ankara (MVA), both of which have excellent safety records. These vaccines have been given to hundreds of healthy volunteers and are now being tested for effectiveness.
In this study we are hoping to increase the immune response against the HCV virus. We will do this by inserting a gene in the vaccine (class-II invariant gene). In animal studies, this approach has been shown to be safe and to significantly to enhance the immune response against HCV.
During this study 15 healthy adults and 10 volunteers who were previously treated for HCV infection, aged 18-65 years, will receive either two intramuscular injections over a period of two months. All participants will be followed up for a further 6 months (12 visits in total) and will be asked to give a blood sample at each clinic visit.
The aims of the study are to assess the safety of the vaccine and to see if the vaccine can induce a strong immune response against the hepatitis C Virus.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each group will be sequentially recruited over a period of two months to allow for safety review.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (low dose/healthy volunteers) | Experimental | Biological: ChAd3-hliNSmut, Biological: MVA-hliNSmut5 healthy volunteers receiving 1 dose ChAd3-hliNSmut (5x10*9 vp) IM at week 0 and 1 dose of MVA-hliNSmut (5 X10*7 pfu) IM at week 8 |
| Group 2 (higher dose/healthy volunteers) | Experimental | Biological: ChAd3-hliNSmut, Biological: MVA-hliNSmut10 healthy volunteers receiving 1 dose ChAd3-hliNSmut (2.5 x10*10 vp) IM at week 0 and 1 dose of MVA-hliNSmut (2 X 10*8 pfu) IM at week 8 |
| Group 3 (higher dose/HCV cured volunteers) | Experimental | Biological: ChAd3-hliNSmut, Biological: MVA-hliNSmut10 DAA treated volunteers (previously HCV positive) receiving 1 dose ChAd3-hliNSmut (2.5 x10*10 vp) IM at week 0 and 1 dose of MVA-hliNSmut (2 X10*8 pfu) IM at week 8 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Aged at least 18 years on the day of screening and no greater than 65 years on the day of the first vaccination
- Resident in or easy access to the trial site for the duration of the study
- Available for follow-up for the planned duration of the study
- Able and willing (in the CI's opinion) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
Key exclusion criteria (36 listed)
- Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned used during the study period
- Prior receipt of a recombinant simian adenoviral vaccine
- Receipt of any investigational HCV vaccine within the last 6 years
- Administration of immunoglobulins and/or any blood products within the last three months preceding the planned administration of the vaccine candidate
- Receipt of live attenuated vaccine within the previous 60 days or planned receipt within 60 days after vaccination with the IMP
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 |
|---|---|---|
| ChAd3-hliNSmutAttenuated chimpanzee adenovirus (ChAd) vectored vaccine against HCV | Biological | Group 1 (low dose/healthy volunteers), Group 2 (higher dose/healthy volunteers), Group 3 (higher dose/HCV cured volunteers) |
| MVA-hliNSmutModified Vaccinia Ankara (MVA) vectored vaccine against HCV | Biological | Group 1 (low dose/healthy volunteers), Group 2 (higher dose/healthy volunteers), Group 3 (higher dose/HCV cured volunteers) |
Primary outcome
Proportion of volunteers who develop a grade 3 local and systemic reactions
Time frame: Actively collected throughout the study until 6 months after the last vaccination
To evaluate the safety of administering HCV prime-boost vaccinations, ChAd3-hliNSmut and MVA-hilNSmut intramuscularly in healthy volunteers and DAA treated volunteers that were previously infected with HCV
1 secondary outcome
Proportion of volunteers who develop T cell responses to HCV epitopes, as determined by INF-gamma ELISpot assay
Time frame: Actively collected throughout the study until 6 months after the last vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Eleanor Barnes, Professor study chair
University of Oxford
Lucy Dorrell, Professor principal investigator
University of Oxford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ChAd3-hliNSmut and MVA-hliNSmut in people with Hepatitis C, run by University of Oxford at 2 sites in United Kingdom.
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 18 inclusion and 36 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: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of volunteers who develop a grade 3 local and systemic reactions (time frame: Actively collected throughout the study until 6 months after the last vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2023; AzTrials last refreshed its copy on 31 Oct 2026.