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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
Trial vaccine
Trial vaccine
Saline placebo vaccine
UZA
Antwerp, Belgium
Erasme Hospital
Brussels, Belgium
UZ Brussel
Brussels, Belgium
Incidence of adverse events to measure safety and reactogenicity
Measure of adverse events, serious adverse events (SAEs), ≥Grade 3 study vaccine-related adverse events reported.
Time frame: 3 months for the lead-in and 12 months for the main phase
Determine the dose of ChAdOx1-HPV plus MVA-HPV vaccines for further development
Measurement of the highest multi-parameter index made of CD4+ magnitude, CD4+ avidity and CD8+ magnitude at peak timepoint
Time frame: 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
The percentage of hrHPV infection clearance
Time frame: 12 months for main phase only
Determine the effect of ChAdOx1-HPV plus MVA-HPV vaccines on cervical intraepithelial neoplasia (CIN)
The percentage of cervical lesions cleared as determined by colposcopy
Time frame: 12 months for main phase only
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Parnu Hospital Womens and Childrens Clinic
Pärnu, Estonia
East-Tallinn Central Hospital
Tallinn, Estonia
North Estonia Medical Centre Foundation Surgery Clinic
Tallinn, Estonia
Tartu University Hospital Womens Clinic
Tartu, Estonia
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
...and 6 more locations