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ChAdOx1-HPV

Phase 1

HPV Infection | Monoclonal antibody | Oncology |Barinthus Biotherapeutics plc|Last Updated: Aug 28, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment108

FDA Designations

No designations recorded

Clinical trial landscape

ChAdOx1-HPV · 1 trial · 2 indications

Phase 1 1
NCT04607850Prime-boost Vaccine Study in Women With Low-grade Cervical HPV LesionsHPV Infection
COMPLETED108 Analytics
PHASE1COMPLETED
Prime-boost Vaccine Study in Women With Low-grade Cervical HPV Lesions
HPV InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events to measure safety and reactogenicity
3 months for the lead-in and 12 months for the main phase

Measure of adverse events, serious adverse events (SAEs), ≥Grade 3 study vaccine-related adverse events reported.

Secondary Endpoints

Determine the dose of ChAdOx1-HPV plus MVA-HPV vaccines for further development
3 months for lead in phase and 12 months for main phase
Determine the effect of ChAdOx1-HPV plus MVA-HPV vaccines on the clearance of high risk HPV infection
12 months for main phase only
Determine the effect of ChAdOx1-HPV plus MVA-HPV vaccines on cervical intraepithelial neoplasia (CIN)
12 months for main phase only
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Lead-in Group A ChAdOx1-HPV low dose and MVA-HPV low doseEXPERIMENTALPrime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^8 vp) and MVA-HPV (1 x 10\^7 pfu)
Lead-in Group B ChAdOx1-HPV mid dose and MVA-HPV low doseEXPERIMENTALPrime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^9 vp) and MVA-HPV (1 x 10\^7 pfu)
Lead-in Group C ChAdOx1-HPV high dose and MVA-HPV high doseEXPERIMENTALPrime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^10) vp and MVA-HPV (1 x 10\^8 pfu)
Group 1 ChAdOx1-HPV mid dose and MVA-HPV low doseEXPERIMENTALPrime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^9 vp) and MVA-HPV (1 x 10\^7 pfu)
Group 2 ChAdOx1-HPV high dose and MVA-HPV low doseEXPERIMENTALPrime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^10 vp) and MVA-HPV (1 x 10\^7 pfu)
Group 3 ChAdOx1-HPV low dose and MVA-HPV high doseEXPERIMENTALPrime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^8 vp) and MVA-HPV (1 x 10\^8 pfu)
Group 4 ChAdOx1-HPV mid dose and MVA-HPV high doseEXPERIMENTALPrime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^9 vp) and MVA-HPV (1 x 10\^8 pfu)
Group 5 ChAdOx1-HPV high dose and MVA-HPV high doseEXPERIMENTALPrime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^10 vp) and MVA-HPV (1 x 10\^8 pfu)
Group 6 Placebo SalinePLACEBO_COMPARATORSodium Chloride (0.9%)

Interventions

NameTypeDescription
ChAdOx1-HPVBIOLOGICALTrial vaccine
MVA-HPVBIOLOGICALTrial vaccine
PlaceboBIOLOGICALSaline placebo vaccine
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Eligibility Criteria

Age Range25 Years to 55 Years
SexFEMALE
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: 1. Females aged ≥25 and ≤55 years of age at screening. 2. Persistent hrHPV infection defined as a documented cervical infection with hrHPV type(s) in the 6 to 18 months prior to screening and confirmed at screening (participants in the main and expansion phases only). Participan...

Countries:BelgiumEstoniaUnited Kingdom
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Frequently asked questions about ChAdOx1-HPV

What is ChAdOx1-HPV used for?

ChAdOx1-HPV is an investigational vaccine being studied for the treatment of HPV infection, specifically in women with low-grade cervical HPV lesions (CIN1). It is in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does ChAdOx1-HPV target?

ChAdOx1-HPV is a vaccine designed to target HPV infection. It is being evaluated in women with low-grade cervical HPV lesions (CIN1) to assess its ability to generate an immune response against the virus.

Who makes ChAdOx1-HPV?

ChAdOx1-HPV is being developed by Barinthus Biotherapeutics plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol BRNS.

What phase is ChAdOx1-HPV in?

ChAdOx1-HPV is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. One Phase 1 trial has been completed.

What clinical trials is ChAdOx1-HPV in?

ChAdOx1-HPV has been studied in one completed Phase 1 clinical trial, NCT04607850, titled 'Prime-boost Vaccine Study in Women With Low-grade Cervical HPV Lesions.' The trial enrolled 108 women aged 25 years and older with HPV infection and CIN1 in Belgium, Estonia, and the United Kingdom.

Is ChAdOx1-HPV the same as a monoclonal antibody?

No, ChAdOx1-HPV is a vaccine, not a monoclonal antibody. It is being developed to treat HPV infection by stimulating the immune system, rather than by directly targeting the virus with antibodies.