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A Study to Assess the Safety of Hep C Vaccine Candidates in HIV Seropositive Individuals | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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)

NCT02568332•University of Oxford

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•* 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
•* 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
+9 more criteria

Exclusion Criteria

•* 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.
+13 more criteria

Locations (2)

St James's Hospital

Dublin, Ireland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Key Dates

Start Date

July 21, 2015

Primary Completion Date

January 26, 2017

Completion Date

October 31, 2017

Last Updated

October 11, 2018

Enrollment

ACTUAL participants

Conditions

Hepatitis C Infection

Interventions

AdCh3NSmut1

BIOLOGICAL

MVA-NSmut

BIOLOGICAL

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

NCT01866930

Chronic Hepatitis C Infection

View study

WITHDRAWNNA

Rapid Diagnostics for HIV and Hepatitis

NCT02190305

HIV InfectionsHepatitis B Infections+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 11, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Rapid Diagnostics for HIV and Hepatitis

Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions

A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis

Assess the Antifibrotic Activity of Fuzheng Huayu in Chronic Hepatitis C Patients With Hepatic Fibrosis