Prime-boost Vaccine Study in Women With Low-grade Cervical HPV Lesions
NCT ID: NCT04607850
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
108 participants
INTERVENTIONAL
2021-03-16
2024-01-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Lead-in Group A ChAdOx1-HPV low dose and MVA-HPV low dose
Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^8 vp) and MVA-HPV (1 x 10\^7 pfu)
ChAdOx1-HPV
Trial vaccine
MVA-HPV
Trial vaccine
Lead-in Group B ChAdOx1-HPV mid dose and MVA-HPV low dose
Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^9 vp) and MVA-HPV (1 x 10\^7 pfu)
ChAdOx1-HPV
Trial vaccine
MVA-HPV
Trial vaccine
Lead-in Group C ChAdOx1-HPV high dose and MVA-HPV high dose
Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^10) vp and MVA-HPV (1 x 10\^8 pfu)
ChAdOx1-HPV
Trial vaccine
MVA-HPV
Trial vaccine
Group 1 ChAdOx1-HPV mid dose and MVA-HPV low dose
Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^9 vp) and MVA-HPV (1 x 10\^7 pfu)
ChAdOx1-HPV
Trial vaccine
MVA-HPV
Trial vaccine
Group 2 ChAdOx1-HPV high dose and MVA-HPV low dose
Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^10 vp) and MVA-HPV (1 x 10\^7 pfu)
ChAdOx1-HPV
Trial vaccine
MVA-HPV
Trial vaccine
Group 3 ChAdOx1-HPV low dose and MVA-HPV high dose
Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^8 vp) and MVA-HPV (1 x 10\^8 pfu)
ChAdOx1-HPV
Trial vaccine
MVA-HPV
Trial vaccine
Group 4 ChAdOx1-HPV mid dose and MVA-HPV high dose
Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^9 vp) and MVA-HPV (1 x 10\^8 pfu)
ChAdOx1-HPV
Trial vaccine
MVA-HPV
Trial vaccine
Group 5 ChAdOx1-HPV high dose and MVA-HPV high dose
Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^10 vp) and MVA-HPV (1 x 10\^8 pfu)
ChAdOx1-HPV
Trial vaccine
MVA-HPV
Trial vaccine
Group 6 Placebo Saline
Sodium Chloride (0.9%)
Placebo
Saline placebo vaccine
Interventions
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ChAdOx1-HPV
Trial vaccine
MVA-HPV
Trial vaccine
Placebo
Saline placebo vaccine
Eligibility Criteria
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Inclusion Criteria
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
* An intrauterine device
* Bilateral tubal occlusion
* Sexual abstinence, only if the participant refrains from heterosexual intercourse during the entire study period and it is the usual lifestyle of the participant
5. Willing to abstain from sexual activity for 48 hours prior to all swabbing procedures
Exclusion Criteria
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 human immunodeficiency virus, hepatitis B or hepatitis C) indicating chronic infection.
4. Evidence of high grade cervical lesions by colposcopy or by Papanicolaou (Pap) smear test in the 1 year prior to screening.
5. 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.
6. 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.
7. 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.
8. 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.
9. Current or history of illicit drug use within the 6 months prior to screening.
10. Current or history of severe alcohol abuse within the 6 months prior to screening.
11. Any laboratory test which is abnormal and deemed by the Investigator to be clinically significant which will potentially affect the participation in the study.
12. Current known infection with severe acute respiratory syndrome coronavirus 2 (SARS CoV-2)
13. Any other finding that, in the opinion of the Investigator, deems the participant unsuitable for the study.
25 Years
55 Years
FEMALE
No
Sponsors
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Barinthus Biotherapeutics
INDUSTRY
Responsible Party
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Locations
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UZA
Antwerp, , Belgium
Erasme Hospital
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Parnu Hospital Womens and Childrens Clinic
Pärnu, , Estonia
East-Tallinn Central Hospital
Tallinn, , Estonia
North Estonia Medical Centre Foundation Surgery Clinic
Tallinn, , Estonia
Tartu University Hospital Womens Clinic
Tartu, , Estonia
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
University Hospital Bristol NHS Trust
Bristol, , United Kingdom
Liverpool Women's NHS Foundation Trust
Liverpool, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Nottingham University Hospital NHS Trust
Nottingham, , United Kingdom
The University of Oxford, Nuffield Department of Women's & Reproductive Health
Oxford, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Countries
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Other Identifiers
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HPV001
Identifier Type: -
Identifier Source: org_study_id
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