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AdCh3NSmut1

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

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 Infection
NCT0256833220
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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 used for?

AdCh3NSmut1 is an investigational vaccine candidate being studied for Hepatitis C Infection. It is a monoclonal antibody modality developed by GSK plc. The drug is currently in Phase 1 clinical development, meaning it is still being tested in clinical trials and is not yet approved for use.

Who makes AdCh3NSmut1?

AdCh3NSmut1 is developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is being studied for the treatment or prevention of Hepatitis C Infection and is currently in Phase 1 clinical trials.

What phase is AdCh3NSmut1 in?

AdCh3NSmut1 is in Phase 1 clinical development. It is an investigational drug being studied for Hepatitis C Infection. As of now, it is not approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy.

What clinical trials is AdCh3NSmut1 in?

AdCh3NSmut1 has one completed clinical trial with the identifier NCT02568332. The trial was titled 'A Study to Assess the Safety of Hep C Vaccine Candidates in HIV Seropositive Individuals' and enrolled 20 participants. It was a Phase 1 study conducted in Ireland and Switzerland.

Is AdCh3NSmut1 the same as other hepatitis C vaccines?

AdCh3NSmut1 is a specific vaccine candidate developed by GSK plc for Hepatitis C Infection. It is currently in Phase 1 clinical trials. The drug is being studied for its safety and potential efficacy, but it is not yet approved for use.