Prime-boost Vaccine Study in Women with Low-grade Cervical HPV Lesions
Research type
Research Study
Full 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
IRAS ID
266074
Contact name
Karin Hellner
Contact email
Sponsor organisation
Vaccitech Ltd
Eudract number
2019-001890-98
Duration of Study in the UK
1 years, 9 months, 27 days
Research summary
This study investigates the safety, tolerability and immunogenicity of ChAdOx1-HPV and MVA-HPV in women between 25 and 55 years old with low-grade cervical lesions associated with persistent High Risk Human Papillomavirus (HPV) infection. This is the first clinical study using the HPV ChAdOx1 and MVA vaccines.
The vaccine is made up of 2 parts given 28 days apart (called a prime-boost vaccine). The ChAdOx1-HPV prime contains DNA coding for 6 proteins from 5 different high risk strains of HPV that are carried in a chimpanzee adenovirus (the vector). A modified poxvirus vector (MVA) boost injection encodes the same proteins as ChAdOx1. The vaccine vectors are modified so that they are unable to grow in the body.
This is a multicentre study to be conducted in up to 15 centres in Europe, and in three phases:
- Lead-in phase in 9 participants at a maximum of 3 sites. Three escalating doses of ChAdOx1-HPV and a fixed dose of MVA-HPV will be investigated. All 9 participants will take part in an immunogenicity sub-study.
- Main phase in 96 participants will start when the last participant in the lead-in phase has received the Day 0 vaccination and the Safety Monitoring Committee has reviewed all available safety and tolerability data from the 3 groups.
Participants will be randomised to one of 5 active treatment groups including 3 dose strengths of ChAdOx1-HPV and 2 dose strengths of MVA-HPV versus one treatment group consisting of 2 placebo injections. Sixty of these participants will take part in the immunogenicity sub-study.
- An Expansion phase: Details to be approved in an amendment.Participants in the lead-in phase will visit the clinic approximately 8 times over a maximum of 4.5 months, and in the main phase approximately 6 times (9 if in the Immunogenicity sub-study) over a maximum of 14.5 months.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0456
Date of REC Opinion
5 Nov 2019
REC opinion
Further Information Favourable Opinion