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ChAd3-hliNSmut

Phase 1

Hepatitis C | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: May 10, 2023

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

ChAd3-hliNSmut · 1 trial · 1 indication

Phase 1 1
NCT03688061Class II Invariant Chain HCV Vaccine StudyHepatitis C
COMPLETED25 Analytics
PHASE1COMPLETED
Class II Invariant Chain HCV Vaccine Study
Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of volunteers who develop a grade 3 local and systemic reactions
Actively collected throughout the study until 6 months after the last vaccination

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

Secondary Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1 (low dose/healthy volunteers)EXPERIMENTAL5 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
Group 2 (higher dose/healthy volunteers)EXPERIMENTAL10 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
Group 3 (higher dose/HCV cured volunteers)EXPERIMENTAL10 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

Interventions

NameTypeDescription
ChAd3-hliNSmutBIOLOGICALAttenuated chimpanzee adenovirus (ChAd) vectored vaccine against HCV
MVA-hliNSmutBIOLOGICALModified Vaccinia Ankara (MVA) vectored vaccine against HCV
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * 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 t...

Countries:United Kingdom
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Competitive Landscape -Hepatitis C 11 trials

Frequently asked questions about ChAd3-hliNSmut

What is ChAd3-hliNSmut used for?

ChAd3-hliNSmut is an investigational vaccine being developed for Hepatitis C. It is currently in Phase 1 clinical development and has completed one trial in the United Kingdom. The vaccine is designed to target Hepatitis C, a viral infection that affects the liver.

Who makes ChAd3-hliNSmut?

ChAd3-hliNSmut is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical research on this investigational Hepatitis C vaccine candidate.

What phase is ChAd3-hliNSmut in?

ChAd3-hliNSmut is in Phase 1 clinical development. It is an investigational vaccine for Hepatitis C and is not yet approved by regulatory authorities. One Phase 1 trial has been completed, with no active trials currently ongoing.

What clinical trials is ChAd3-hliNSmut in?

ChAd3-hliNSmut has been studied in one clinical trial with the identifier NCT03688061, titled 'Class II Invariant Chain HCV Vaccine Study'. This Phase 1 trial was completed in the United Kingdom and enrolled 25 participants, including healthy volunteers aged 18 years and older.

Is ChAd3-hliNSmut the same as a monoclonal antibody?

ChAd3-hliNSmut is classified as a monoclonal antibody modality, though it is being studied as a vaccine for Hepatitis C. The trial for this candidate enrolled healthy volunteers and was controlled, but it was not randomized or double-blind.