NCT04607850

Prime-boost Vaccine Study in Women With Low-grade Cervical HPV Lesions

A Phase 1b/2, Randomised, Placebo-controlled, Dose-ranging Study to Evaluate Safety, Tolerability and Immunogenicity of a Chimpanzee Adenovirus (ChAdOx1)-Vectored Multigenotype High Risk Human Papillomavirus (hrHPV) Vaccine and Modified Vaccinia Ankara (MVA)-Vectored Multigenotype hrHPV Vaccine in Women With Low-grade HPV-related Cervical Lesions

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Barinthus Biotherapeutics · Industry
• Sex: Female
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1b/2 multi-centre study evaluating the safety, efficacy and immunogenicity of prime-boost vaccines ChAdOx1-HPV and MVA-HPV in women with HPV related low grade cervical lesions.

Detailed description

The study consists of an open label, non-randomised, dose escalation Lead in phase. 9 participants with high-risk HPV, in cohorts of 3 in 3 dose ascending groups, will be vaccinated after SMC safety data reviews. This is followed by a blinded, randomised Main phase with 96 participants with high-risk HPV, in parallel running dose cohorts (three different doses of ChAdOx1-HPV plus two different doses of MVA-HPV versus placebo plus placebo boost). At least 60 of these participants will take part in the immunogenicity sub-study. A blinded, randomised expansion phase investigating the effects of up to two different main phase doses against placebo will be further defined prior to commencing this phase of the study.

Conditions

• HPV Infection
• CIN1

Interventions

Type	Name	Description
BIOLOGICAL	ChAdOx1-HPV	Trial vaccine
BIOLOGICAL	MVA-HPV	Trial vaccine
BIOLOGICAL	Placebo	Saline placebo vaccine

Timeline

• Start date: 2021-03-16
• Primary completion: 2024-01-16
• Completion: 2024-01-16
• First posted: 2020-10-29
• Last updated: 2025-08-28

Locations

16 sites across 3 countries: Belgium, Estonia, United Kingdom