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 - Prime-boost Vaccine Study in Women with Low-grade Cervical HPV Lesions

Vaccitech Ltd.0 sites105 target enrollmentMarch 9, 2020

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 9, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Vaccitech Ltd.

Eligibility Criteria

Inclusion Criteria

•Participants must meet all the following criteria to be eligible for the study:
•1\. Females aged \=25 and \=55 years of age at screening.
•2\. Persistent hrHPV infection defined as a documented cervical infection with hrHPV type(s) in the 6 to 18 months prior to screening and confirmed at screening (participants in the main and expansion phases only). Participants in the lead in phase are only required to have the screening result.
•3\. Low grade cervical lesion (CIN1 or HPV related change only) confirmed by histology and/or cytology report within the 1 year prior to screening.
•4\. Not pregnant or breast feeding and one of the following:
•Of non\-childbearing potential (i.e. women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses for at least 12 months and without an alternative medical cause.)
•Of childbearing potential but agrees to practice highly effective contraception for 4 weeks prior to administration of the first dose of study vaccine and throughout the study until 8 weeks after administration of the second dose. Highly effective methods of contraception include one or more of the following:
•\- Male partner who is sterile (medically effective vasectomy) prior to the female participant’s entry into the study and is the sole sexual partner for the female participant
•\- Hormonal (oral, intravaginal, transdermal, implantable or injectable). Progestogen\-only hormonal contraceptives without inhibition of ovulation are not considered to be highly effective.
•\- An intrauterine hormone releasing system

Exclusion Criteria

•Participants who meet any of the following criteria are not eligible for the study:
•1\. Presence of any significant acute or chronic, uncontrolled medical (or psychiatric) illness, including blood dyscracias.
•2\. Immunosuppression as a result of underlying illness or treatment including:
•Use of high dose corticosteroids (\>10 mg/day prednisone or equivalent) for \=7 days (inhaled, otic and ophthalmic corticosteroids are permitted)
•Primary immune deficiency disease
•Use of synthetic or biologic disease\-modifying antirheumatic drugs
•History of bone marrow or solid organ transplant
•History of any other clinically significant autoimmune or immunosuppressive disease
•3\. Positive diagnostic tests (for HIV, hepatitis B, or HCV) indicating chronic infection.
•4\. Evidence of high grade cervical lesions by colposcopy or by Pap smear test in the 1 year prior to screening.