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 February, 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