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
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
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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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