Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04607850
Status:
COMPLETED
Last Update Posted:
2024-01-19
First Post:
2020-10-22
Brief Title:
Prime-boost Vaccine Study in Women With Low-grade Cervical HPV Lesions
Sponsor:
Barinthus Biotherapeutics
Organization:
Barinthus Biotherapeutics
Study Overview
Official Title:
A Phase 1b2 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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase 1b2 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None