Hepatitis C InfectionPhase 1NCT02362217

A Study to Assess the Safety of HIV and Hep C Vaccine Candidates When Given Separately or in Combination

A Phase 1 study testing AdCh3NSmut1, MVA-NSmut and ChAdV63.HIVconsv in people with Hepatitis C Infection and HIV Infection, run by University of Oxford at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is aimed at assessing the safety of candidate Hepatitis C vaccines AdCh3NSmut/MVA-NSmut and HIV vaccines ChAdV63.HIVconsv/MVA.HIVconsv when administered separately or in combination to healthy volunteers. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Hepatitis C Infection, HIV Infection
What is being tested?: AdCh3NSmut1, MVA-NSmut and ChAdV63.HIVconsv
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteUnited Kingdom
Study dates: Oct 2014to 31 Oct 2017
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males or females, as assessed by medical history, physical examination and laboratory tests
Aged at least 18 years on the day of screening and no greater than 50 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 Chief 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

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For females, willingness to practice continuous effective contraception from screening until 4 months after the last immunisation.
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 an approved method of contraception until four 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/HIV-1 testing, counselling and receive test results

Who cannot join

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 adenoviral vaccine
Receipt of any investigational HIV-1 or HCV vaccine within the last 6 years
Administration of immunoglobulins and/or any blood products within the 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 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
History of clinically significant contact dermatitis
Any history of anaphylaxis in reaction to vaccination
Pregnancy, lactation or 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 use
Reported high-risk behaviour for HIV-1 / HCV infection
Seropositive for hepatitis B surface antigen (HBsAg)
Seropositive for HIV-1 (antibodies to HIV-1) at screening
Seropositive for hepatitis C virus (antibodies to HCV) at screening
Any other 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 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
Vulnerable subjects (according to ICH GCP)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, OX3 7LE

Other trials in United Kingdom

About this study

Official title: A Phase I Study to Evaluate the Safety and Immunogenicity of Simultaneous Prime-Boost Immunisations With Candidate HCV and HIV-1 Vaccines, AdCh3NSmut1 / ChAdV63.HIVconsv and MVA-NSmut / MVA.HIVconsv, in Healthy Volunteers

Read the detailed description

Hepatitis C and HIV are both widespread pathogens. By the end of 2010, there were 2.3 million people in Europe living with HIV, over half of whom were coinfected with the Hepatitis C virus (HCV). Although vaccination is the optimal method of preventing infection, it has proved extremely difficult to develop an effective vaccine against HIV and HCV due to the enormous variation in strains around the world. This is caused by the extraordinary ability of the viruses to change their genetic material.

Researchers at the University of Oxford have developed novel candidate vaccines against HIV ('HIV.consv') and HCV ('NSmut'). These vaccines have been inserted into the carrier viruses Chimpanzee Adenovirus (ChAd or AdCh) and modified vaccinia virus Ankara (MVA), both of which have excellent safety records. The aim of this study is to test for the first time the response of the immune system when vaccines to both HIV and HCV are given together.

During this study, 32 healthy adults aged 18 to 50 years will be recruited into one of three groups to receive either two or four intramuscular injections over a period of two months. All participants will be followed up for a further six months (12 visits in total).

Conditions: Hepatitis C Infection, HIV Infection
Being tested: AdCh3NSmut1, MVA-NSmut, ChAdV63.HIVconsv, MVA.HIVconsv
Medical subject headings: Hepatitis C, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AdCh3NSmut1Biological
Genetic vaccine against Hepatitis C virus infection
MVA-NSmutBiological
Genetic vaccine against Hepatitis C virus infection
ChAdV63.HIVconsvBiological
Genetic vaccine against HIV-1 infection
MVA.HIVconsvBiological
Genetic vaccine against HIV-1 infection

Study groups in NCT02362217
Study group	Role	What they receive
Group 1	Experimental	Interventions: AdCh3NSmut1, MVA-NSmut. Administration schedule: 1 dose AdCh3NSmut1 2.5 x 10^10 vp at week 0 and 1 dose MVA-NSmut 2 x 10^8 pfu at week 8. Subjects: 8 healthy volunteers. Receives: Biological: AdCh3NSmut1; Biological: MVA-NSmut
Group 2	Experimental	Interventions: ChAdV63.HIVconsv, MVA.HIVconsv. Administration schedule: 1 dose ChAdV63.HIVconsv 5 x 10^10 vp at week 0 and 1 dose MVA.HIVconsv 2 x 10^8 pfu at week 8. Subjects: 8 healthy volunteers. Receives: Biological: ChAdV63.HIVconsv; Biological: MVA.HIVconsv
Group 3	Experimental	Interventions: AdCh3NSmut1, MVA-NSmut, ChAdV63.HIVconsv, MVA.HIVconsv. Administration schedule: 1 dose AdCh3NSmut1 2.5 x 10^10 vp and 1 dose ChAdV63.HIVconsv 5 x 10^10 vp at week 0, and 1 dose MVA-NSmut 1 x 10^8 pfu and 1 dose MVA.HIVconsv 1 x 10^8 pfu at week 8. Subjects: 16 healthy volunteers. Receives: Biological: AdCh3NSmut1; Biological: MVA-NSmut; Biological: ChAdV63.HIVconsv; Biological: MVA.HIVconsv

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety of administering simultaneous HCV/HIV-1 prime-boost vaccinations, as measured by the proportion of volunteers who develop a grade 3 or 4 local or systemic reaction
Proportion of volunteers who develop a grade 3 or 4 local reaction Proportion of volunteers who develop a grade 3 or 4 systemic reaction
Measured: Actively collected throughout the study until 6 months after the last vaccination

Secondary outcomes (1)

Cellular immune response generated by simultaneous HCV/HIV-1 prime-boost vaccinations, as determined by analysing changes in the magnitude or quality of HCV and HIV-1-specific cellular immune responses.
Immunogenicity determined by analysing changes from baseline in the magnitude or quality of HCV and HIV-1-specific cellular immune responses. These will be detected using several standardised assays. The primary outcome measure for immunogenicity will be the development of T cell responses to HCV and HIV-1 epitopes, as determined by IFN-ɣ ELISpot assay. In addition, several exploratory immunology assays (including but not limited to intracellular cytokine staining, phenotype, viral suppression in vitro) will be developed and used.
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.

Oct 201431 Oct 2017

First posted12 Feb 2015 (estimated)
Study startOct 2014
Primary completionAug 2016
Study completion31 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis C InfectionStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02362217
Sponsor's protocol ID: PEACHI-04
Status last verified: Oct 2018
First submitted: 6 Nov 2014
Last updated: 11 Oct 2018
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Hartnell F, Brown A, Capone S, Kopycinski J, Bliss C, Makvandi-Nejad S, Swadling L, Ghaffari E, Cicconi P, Del Sorbo M, Sbrocchi R, Esposito I, Vassilev V, Marriott P, Gardiner CM, Bannan C, Bergin C, Hoffmann M, Turner B, Nicosia A, Folgori A, Hanke T, Barnes E, Dorrell L. A Novel Vaccine Strategy Employing Serologically Different Chimpanzee Adenoviral Vectors for the Prevention of HIV-1 and HCV Coinfection. Front Immunol. 2019 Jan 18;9:3175. doi: 10.3389/fimmu.2018.03175. eCollection 2018.
PubMed 30713538

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
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Active, not recruitingPhase 4
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All Hepatitis C Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study to Evaluate the Safety and Immunogenicity of Simultaneous Prime-Boost Immunisations With Candidate HCV and HIV-1 Vaccines, AdCh3NSmut1 / ChAdV63.HIVconsv and MVA-NSmut / MVA.HIVconsv, in Healthy Volunteers
ClinicalTrials.gov ID: NCT02362217
Acronym / sponsor ID: PEACHI-04
Conditions: Hepatitis C Infection, HIV Infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: University of OxfordUniversity, hospital or other
Collaborators: ReiThera Srl, GlaxoSmithKline
Study start: Oct 2014 (actual)
Primary completion: Aug 2016 (actual)
Study completion: 31 Oct 2017 (actual)
First posted: 12 Feb 2015 (estimated)
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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group 1	Experimental	Biological: AdCh3NSmut1, Biological: MVA-NSmutInterventions: AdCh3NSmut1, MVA-NSmut. Administration schedule: 1 dose AdCh3NSmut1 2.5 x 10^10 vp at week 0 and 1 dose MVA-NSmut 2 x 10^8 pfu at week 8. Subjects: 8 healthy volunteers.
Group 2	Experimental	Biological: ChAdV63.HIVconsv, Biological: MVA.HIVconsvInterventions: ChAdV63.HIVconsv, MVA.HIVconsv. Administration schedule: 1 dose ChAdV63.HIVconsv 5 x 10^10 vp at week 0 and 1 dose MVA.HIVconsv 2 x 10^8 pfu at week 8. Subjects: 8 healthy volunteers.
Group 3	Experimental	Biological: AdCh3NSmut1, Biological: MVA-NSmut, Biological: ChAdV63.HIVconsv, Biological: MVA.HIVconsvInterventions: AdCh3NSmut1, MVA-NSmut, ChAdV63.HIVconsv, MVA.HIVconsv. Administration schedule: 1 dose AdCh3NSmut1 2.5 x 10^10 vp and 1 dose ChAdV63.HIVconsv 5 x 10^10 vp at week 0, and 1 dose MVA-NSmut 1 x 10^8 pfu and 1 dose MVA.HIVconsv 1 x 10^8 pfu at week 8. Subjects: 16 healthy volunteers.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Healthy males or females, as assessed by medical history, physical examination and laboratory tests
Aged at least 18 years on the day of screening and no greater than 50 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 Chief Investigator's opinion) to comply with all study requirements

Key exclusion criteria (24 listed)

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 adenoviral vaccine
Receipt of any investigational HIV-1 or HCV vaccine within the last 6 years
Administration of immunoglobulins and/or any blood products within the 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
AdCh3NSmut1Genetic vaccine against Hepatitis C virus infection	Biological	Group 1, Group 3
MVA-NSmutGenetic vaccine against Hepatitis C virus infection	Biological	Group 1, Group 3
ChAdV63.HIVconsvGenetic vaccine against HIV-1 infection	Biological	Group 2, Group 3
MVA.HIVconsvGenetic vaccine against HIV-1 infection	Biological	Group 2, Group 3

Primary outcome

Safety of administering simultaneous HCV/HIV-1 prime-boost vaccinations, as measured by the proportion of volunteers who develop a grade 3 or 4 local or systemic reaction
Time frame: Actively collected throughout the study until 6 months after the last vaccination
Proportion of volunteers who develop a grade 3 or 4 local reaction Proportion of volunteers who develop a grade 3 or 4 systemic reaction

1 secondary outcome

Cellular immune response generated by simultaneous HCV/HIV-1 prime-boost vaccinations, as determined by analysing changes in the magnitude or quality of HCV and HIV-1-specific cellular immune responses.
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 11 Oct 2018.
Derived from this study: PubMed 30713538Hartnell F, Brown A, Capone S, Kopycinski J, Bliss C, Makvandi-Nejad S, Swadling L, Ghaffari E, Cicconi P, Del Sorbo M, Sbrocchi R, Esposito I, Vassilev V, Marriott P, Gardiner CM, Bannan C, Bergin C, Hoffmann M, Turner B, Nicosia A, Folgori A, Hanke T, Barnes E, Dorrell L. A Novel Vaccine Strategy Employing Serologically Different Chimpanzee Adenoviral Vectors for the Prevention of HIV-1 and HCV Coinfection. Front Immunol. 2019 Jan 18;9:3175. doi: 10.3389/fimmu.2018.03175. eCollection 2018.
Individual participant dataSharing planned: Undecided

Related trials for Hepatitis C Infection

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
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Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
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Active, not recruitingPhase 4
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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.

Lucy Dorrell, Prof. study chair

University of Oxford

Ellie Barnes, Prof. principal investigator

University of Oxford

Tomas Hanke, Prof. principal investigator

University of Oxford

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AdCh3NSmut1, MVA-NSmut and ChAdV63.HIVconsv in people with Hepatitis C Infection and HIV Infection, run by University of Oxford at 1 site 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 12 inclusion and 24 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 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Safety of administering simultaneous HCV/HIV-1 prime-boost vaccinations, as measured by the proportion of volunteers who develop a grade 3 or 4 local or systemic reaction (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?

On the ClinicalTrials.gov record for NCT02362217, which also lists 1 linked publication.

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 11 Oct 2018.