A first-in human, Phase 1b/2, study to evaluate the safety, tolerability and immunogenicity of HPV viral vectored vaccines in women with low-grade HPV-related cervical lesions

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Study title: 
A first-in human, Phase 1b/2, study to evaluate the safety, tolerability and immunogenicity of HPV viral vectored vaccines in women with low-grade HPV-related cervical lesions
Long title: 
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
Date receipt dossier: 
28 Feb 2020
EU record number: 
B/BE/20/BVW2
Company / Sponsor: 
Vaccitech Limited
Phase: 
Ib/II
Treated organism: 
Humans
Indication category: 
Vaccination
Disease: 
Human Papilloma Virus (HPV) infection
Therapeutic approach: 
Prevention
Genetic modification: 
The study involves two GMOs. ChAdOx1-HPV is a recombinant replication-incompetent chimpanzee-derived adenovirus (ChAdY25) viral vector. MVA-HPV is a modified vaccinia virus Ankara vector (MVA). Both vectors encode a fusion of sequences derived from HPV.
Method of transfer of nucleic acid of interest: 
Replication-defective simian (chimpanzee-derived) group C adenovirus, and modified vaccinia virus Ankara vector (MVA)
Administered biological material: 
Recombinant viruses
Route of administration: 
Intramuscular
Locations in Belgium: 
Universitair Ziekenhuis Brussel, Universitair Ziekenhuis Gent, Hôpital Erasme Bruxelles, Universitair Ziekenhuis Antwerpen
Nr of subjects: 
64
Foreseen duration: 
8 June 2020 until 30 November 2021
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

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