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

  • STATUS
    Recruiting
  • End date
    Dec 23, 2023
  • participants needed
    105
  • sponsor
    Vaccitech (UK) Limited
Updated on 23 October 2022

Summary

A Phase 1b/2 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.

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.

Details
Condition HPV Infection, CIN1
Treatment Placebo, ChAdOx1-HPV, MVA-HPV
Clinical Study IdentifierNCT04607850
SponsorVaccitech (UK) Limited
Last Modified on23 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Females aged ≥25 and ≤55 years of age at screening
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
Low- grade cervical lesion (CIN1 or HPV-related change only) confirmed by histology and/or cytology report within the 1 year prior to screening
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
An intrauterine device
Bilateral tubal occlusion
Willing to abstain from sexual activity for 48 hours prior to all swabbing procedures
Sexual abstinence, only if the participant refrains from heterosexual intercourse during the entire study period and it is the usual lifestyle of the participant

Exclusion Criteria

Presence of any significant acute or chronic, uncontrolled medical (or psychiatric) illness, including blood dyscrasias
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
Positive diagnostic tests (for human immunodeficiency virus, hepatitis B or hepatitis
indicating chronic infection
Evidence of high grade cervical lesions by colposcopy or by Papanicolaou (Pap) smear test in the 1 year prior to screening
Receipt of any investigational drug or investigational vaccine within 3 months prior to administration of ChAdOx1-HPV on Day 0, or prior participation in a clinical study of any HPV vaccine
Any history of anaphylaxis in reaction to vaccination or history of allergic reactions likely to be exacerbated by any component of the vaccine, e.g. severe allergy to eggs
Receipt of any live vaccines within the 30 days or inactivated vaccine within the 14 days prior to administration of ChAdOx1-HPV on Day 0 or planned to occur in the 2 months after the Day 0 vaccination
Current or history of illicit drug use within the 6 months prior to screening
Receipt of any adenoviral based vaccine within 3 months prior to administration of ChAdOx1 HPV on Day 0, or plan to receive an adenoviral-based vaccine within 3 months after Day 0
Current or history of severe alcohol abuse within the 6 months prior to screening
Any laboratory test which is abnormal and deemed by the Investigator to be clinically significant which will potentially affect the participation in the study
Any other finding that, in the opinion of the Investigator, deems the participant unsuitable for the study
Current known infection with severe acute respiratory syndrome coronavirus 2 (SARS CoV-2)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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