NCT03688061

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2017

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2022

Completed
Last Updated

May 10, 2023

Status Verified

September 1, 2018

Enrollment Period

1.7 years

First QC Date

September 19, 2018

Last Update Submit

May 9, 2023

Conditions

Hepatitis C

Keywords

HepatitisVaccineAdenoviral-vectorhuman invariant chain

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    Actively collected throughout the study until 6 months after the last vaccination

Study Arms (3)

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

Biological: ChAd3-hliNSmutBiological: 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

Biological: ChAd3-hliNSmutBiological: 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

Biological: ChAd3-hliNSmutBiological: MVA-hliNSmut

Interventions

ChAd3-hliNSmutBIOLOGICAL

Attenuated chimpanzee adenovirus (ChAd) vectored vaccine against HCV

Group 1 (low dose/healthy volunteers)Group 2 (higher dose/healthy volunteers)Group 3 (higher dose/HCV cured volunteers)
MVA-hliNSmutBIOLOGICAL

Modified Vaccinia Ankara (MVA) vectored vaccine against HCV

Group 1 (low dose/healthy volunteers)Group 2 (higher dose/healthy volunteers)Group 3 (higher dose/HCV cured volunteers)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.
  • +3 more criteria

You may not qualify if:

  • 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
  • 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
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre for Cinical Vaccinology and Tropical Medicine, Univeristy of Oxford

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Hepatology Clinical Trial Unit, John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis CHepatitis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsLiver DiseasesDigestive System Diseases

Study Officials

  • Eleanor Barnes, Professor

    University of Oxford

    STUDY CHAIR

  • Lucy Dorrell, Professor

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Each group will be sequentially recruited over a period of two months to allow for safety review.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2018

First Posted

September 27, 2018

Study Start

December 4, 2017

Primary Completion

August 4, 2019

Study Completion

August 4, 2022

Last Updated

May 10, 2023

Record last verified: 2018-09

Locations

GB(2)