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Hepatitis C InfectionPhase 1NCT02568332

A Study to Assess the Safety of Hep C Vaccine Candidates in HIV Seropositive Individuals

A Phase 1 study testing AdCh3NSmut1 and MVA-NSmut in people with Hepatitis C Infection, run by University of Oxford at 2 sites in 2 countries.

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 (Hep C) vaccines AdCh3NSmut1 and MVA-NSmut when administered to Human Immunodeficiency Virus (HIV) seropositive individuals. This study also aims to assess the cellular immune response generated by these vaccines when administered as mentioned above. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hepatitis C Infection
What is being tested?
AdCh3NSmut1 and MVA-NSmut
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesin 2 countries
Study dates
21 Jul 2015to 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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • HIV-1 seropositive adults must satisfy all the following inclusion criteria to be eligible for the study:
  • Aged 18 to 60 years (inclusive)
  • Resident in or near the trial sites for the duration of the vaccination study for the participant
  • Able and willing (in the Investigator's opinion) to comply with all study requirements
  • HIV Viral Load <50 copies/mL at the last routine HIV follow-up visit within the last 9 months prior to inclusion whilst on treatment with an effective ART regimen
  • Willingness to remain on ART for the study duration
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  • CD4 cell count above 350 cells/uL
  • Negative HCV serology and negative HCV RNA polymerase chain reaction (PCR) testing
  • For women of child bearing potential, willingness to practise continuous effective contraception during the study and a negative pregnancy test on the day(s) of vaccination. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. In subjects on ART, these are:
  • Injectable progestogen
  • Male partner sterilisation prior to the female subject's entry into the study, and this male is the sole partner for that subject
  • Male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository)
  • Intrauterine device or intrauterine system
  • In addition male partners should use condoms until 3 months after the last vaccination
  • Male trial participants with a female partner of child bearing potential should use condoms until 3 months after the last vaccination. In addition, the female partner should use one of the following contraceptive methods, i.e.
  • Oral or injectable hormonal contraception
  • Sterilisation
  • Intrauterine device or intrauterine system
  • Male trial participants with pregnant partners should use condoms until 3 months after the last vaccination
  • Written informed consent

Who cannot join

  • HIV-1 seropositive adults may not enter the study if any of the following exclusion criteria 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
  • Clinical, biochemical (abnormal liver synthetic dysfunction defined by an elevated blood prothrombin time or a low blood albumin level), ultrasonographic, FibroscanTM, or liver biopsy (histology) evidence of cirrhosis or portal hypertension
  • Ongoing or recent (<12 months) AIDS defining illness (US Centers for Disease Control and Prevention (CDC) definition)
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including egg products or gentamicin.
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  • History of clinically significant contact dermatitis
  • Any history of anaphylaxis or serious reaction in relation to vaccination
  • Pregnancy, lactation or willingness/intention to become pregnant during the study
  • Known active malignant disease (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  • Current suspected or known injecting drug abuse (except individuals participating in a heroin substitution program without known or suspected concomitant drug abuse). Participants will be counselled regarding the risk of HCV acquisition during the trial.
  • Seropositive for hepatitis B surface antigen (HBsAg)
  • Positive test for Hepatitis C antibody and/or PCR
  • Moderate neutropenia (Absolute neutrophil count of <1,000 cells/uL)
  • Moderate thrombocytopenia (Platelet count <80,000 cells/uL)
  • Anaemia (Haemoglobin <10g/dL)
  • History of pericarditis and/or myocarditis
  • Heart failure (left ventricular ejection fraction <20%) in the patient history or current medical treatment for heart failure.
  • History of immunologically mediated disease (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management)
  • History of organ transplantation
  • History of severe psychiatric disease, including psychosis and/or depression, characterised by a suicide attempt, hospitalisation for psychiatric disease, or a period of disability as a result of psychiatric disease.
  • History of a significant coagulopathy (i.e. International Normalised Ratio (INR) > 1.3 and/or Activated Partial Thromboplastin Time (APTT) > 1.5 upper limits of normal) or anticoagulant therapy at time of vaccination
  • Receipt of any oral or systemic antineoplastic or immunomodulatory (e.g. oral systemic corticosteroids) treatment or radiation within 24 weeks before Day 0 or the expectation that such treatment will be needed at any time during the study. Topical or inhaled corticosteroid use is allowed.
  • Any other significant disease, disorder or finding, which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or may influence the result of the study, or the patient's ability to participate in the study

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Ireland1 site

  • St James's Hospital

    Dublin, Dublin 8

Other trials in Ireland

Switzerland1 site

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

About this study

Official title: A Phase I Study to Assess the Safety and Immunogenicity of Prime-boost Immunisations With Vaccine Candidates AdCh3NSmut1 and MVA-NSmut in HIV-1 Seropositive HCV-uninfected Adults on Antiretroviral Therapy (ART)

This study is aimed at assessing the safety of candidate Hepatitis C (Hep C) vaccines AdCh3NSmut1 and MVA-NSmut when administered to Human Immunodeficiency Virus (HIV) seropositive individuals. This study also aims to assess the cellular immune response generated by these vaccines when administered as mentioned above.

Read the detailed description

Hepatitis C (Hep C) is a common infection. Worldwide, over 180 million people are infected. Hep C is a blood borne viral infection spread through direct contact with the blood of an infected person. People with Hep C frequently have no symptoms and infection can lead to fibrosis (scarring of the liver), liver failure and cancer. Infection with the Hep C virus (HCV) progresses more rapidly to liver damage in Human Immunodeficiency Virus (HIV)-infected individuals.

Researchers at the University of Oxford have developed a novel candidate vaccine against HCV ('NSmut'). This vaccine has been inserted into the carrier viruses Chimpanzee Adenovirus 3 (AdCh3) and modified vaccinia virus Ankara (MVA), both of which have excellent safety records and have been previously tested in people.

However, the objective of this study is to use exploratory immunological assays to assess whether vaccines for Hep C can induce immune responses in HIV positive individuals that are similar in strength to those in healthy volunteers.

Being tested
AdCh3NSmut1, MVA-NSmut
Medical subject headings
Hepatitis C

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

Study groups in NCT02568332
Study groupRoleWhat they receive
Group 1ExperimentalInterventions: 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: 20 HIV seropositive individuals
Receives: Biological: AdCh3NSmut1; Biological: MVA-NSmut

What is being measured

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

  1. Safety of administering HCV prime-boost vaccinations to HIV seropositive individuals, as measured by the proportion of participants who develop a grade 3 or 4 local or systemic reaction

    Measured: From Day 0 until 6 months after the last vaccination

Secondary outcomes (1)

  1. Cellular immune response generated by HCV prime-boost vaccinations in HIV seropositive individuals, as determined by analysing changes in the magnitude or quality of HCV-specific cellular immune responses

    Immunogenicity determined by analysing changes from baseline in the magnitude or quality of HCV-specific cellular immune responses. The primary outcome measure for immunogenicity will be the development of T cell responses to HCV epitopes, as determined by Interferon (IFN)-ɣ Enzyme-Linked ImmunoSpot (ELISpot) assay.

    Measured: From Day 0 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.

  1. First posted5 Oct 2015 (estimated)
  2. Study start21 Jul 2015
  3. Primary completion26 Jan 2017
  4. Study completion31 Oct 2017

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02568332
Sponsor's protocol ID
PEACHI-02
Status last verified
May 2017
First submitted
22 Sep 2015
Last updated
11 Oct 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AdCh3NSmut1 and MVA-NSmut in people with Hepatitis C Infection, run by University of Oxford at 2 sites in 2 countries.

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 20 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 2 sites in Ireland, Switzerland. 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 HCV prime-boost vaccinations to HIV seropositive individuals, as measured by the proportion of participants who develop a grade 3 or 4 local or systemic reaction (time frame: From Day 0 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 NCT02568332.

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.

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