NCT02568332

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2015

Typical duration for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

October 11, 2018

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

September 22, 2015

Last Update Submit

October 10, 2018

Conditions

Hepatitis C Infection

Outcome Measures

Primary Outcomes (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

    From Day 0 until 6 months after the last vaccination

Secondary Outcomes (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

    From Day 0 until 6 months after the last vaccination

Study Arms (1)

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: 20 HIV seropositive individuals

Biological: AdCh3NSmut1Biological: MVA-NSmut

Interventions

AdCh3NSmut1BIOLOGICAL

Genetic vaccine against Hepatitis C virus infection

Group 1
MVA-NSmutBIOLOGICAL

Genetic vaccine against Hepatitis C virus infection

Group 1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • Willingness to remain on ART for the study duration
  • 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
  • +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 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.
  • 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)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St James's Hospital

Dublin, Dublin 8, Ireland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lucy Dorrell, Prof

    University of Oxford

    STUDY CHAIR

  • Ellie Barnes, Prof

    University of Oxford

    PRINCIPAL INVESTIGATOR

  • Matthias Hoffmann, Dr

    Cantonal Hospital of St. Gallen

    PRINCIPAL INVESTIGATOR

  • Colm Bergin, Prof

    St. James's Hospital, Ireland

    PRINCIPAL INVESTIGATOR

  • Pietro Vernazza, Prof

    Cantonal Hospital of St. Gallen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2015

First Posted

October 5, 2015

Study Start

July 21, 2015

Primary Completion

January 26, 2017

Study Completion

October 31, 2017

Last Updated

October 11, 2018

Record last verified: 2017-05

Locations

CH(1)IE(1)