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AdCh3NSmut1

Phase 1

Hepatitis C Infection | Monoclonal antibody | Infectious Disease |GSK plc|Trials Updated: Oct 11, 2018

AdCh3NSmut1 development status

Highest phase Phase 1
Registered trials 2 across 2 sponsors since Sep 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

AdCh3NSmut1 clinical trials

AdCh3NSmut1 · 1 trial · 1 indication

Phase 1 1
NCT02568332A Study to Assess the Safety of Hep C Vaccine Candidates in HIV Seropositive IndividualsHepatitis C Infection
COMPLETED20 Analytics
PHASE1COMPLETED
A Study to Assess the Safety of Hep C Vaccine Candidates in HIV Seropositive Individuals
Hepatitis C InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
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

Interventions

NameTypeDescription
AdCh3NSmut1BIOLOGICALGenetic vaccine against Hepatitis C virus infection
MVA-NSmutBIOLOGICALGenetic vaccine against Hepatitis C virus infection
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * 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 Inv...

Countries:IrelandSwitzerland
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Frequently asked questions about AdCh3NSmut1

What is AdCh3NSmut1?

AdCh3NSmut1 is an investigational vaccine candidate developed by GSK plc for Hepatitis C Infection. It has been studied in a Phase 1 clinical trial in HIV seropositive individuals. The candidate is designed to assess safety in this population. It is not approved for any indication and remains in clinical development.

What is AdCh3NSmut1 used for?

AdCh3NSmut1 is being developed for the prevention or treatment of Hepatitis C Infection. It has been evaluated in a Phase 1 trial involving HIV seropositive individuals. The study assessed the safety of Hepatitis C vaccine candidates. AdCh3NSmut1 is investigational and has not been approved for use.

Who makes AdCh3NSmut1?

AdCh3NSmut1 is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this Hepatitis C vaccine candidate. The company conducted a Phase 1 trial in HIV seropositive individuals to assess safety.

What phase is AdCh3NSmut1 in?

AdCh3NSmut1 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The trial enrolled 20 participants. AdCh3NSmut1 is investigational and has not received regulatory approval for any indication.

What clinical trials is AdCh3NSmut1 in?

AdCh3NSmut1 has been studied in one completed Phase 1 trial, NCT02568332, titled "A Study to Assess the Safety of Hep C Vaccine Candidates in HIV Seropositive Individuals." The trial enrolled 20 participants across Ireland and Switzerland. It was an uncontrolled study without randomization or blinding.