Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-03-26 @ 8:15 PM
Study NCT ID:
NCT04607850
Status:
COMPLETED
Last Update Posted:
2025-08-28
First Post:
2020-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prime-boost Vaccine Study in Women With Low-grade Cervical HPV Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Lead in phase will be open label. Main phase and expansion phase will be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2020-10-22', 'studyFirstSubmitQcDate': '2020-10-22', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assess the complex cellular immune response generated by ChAdOx1-HPV plus MVA-HPV vaccines', 'timeFrame': '3 months for lead in phase and 12 months for main phase', 'description': 'This will be assessed by measuring the individual phenotypic subsets of CD4+ and CD8+ T cells induced by vaccination'}, {'measure': 'Assess the complex cellular immune response generated by ChAdOx1-HPV plus MVA-HPV vaccines', 'timeFrame': '3 months for lead in phase and 12 months for main phase', 'description': 'This will be assessed by measuring the innate immune response after vaccination compared to baseline'}, {'measure': 'Assess the complex cellular immune response generated by ChAdOx1-HPV plus MVA-HPV vaccines', 'timeFrame': '3 months for lead in phase and 12 months for main phase', 'description': 'This will be assessed by measuring the T cell breadth of response to the components of the ChAdOx1-HPV plus MVA-HPV vaccines'}, {'measure': 'Assess the complex cellular immune response generated by ChAdOx1-HPV plus MVA-HPV vaccines', 'timeFrame': '3 months for lead in phase and 12 months for main phase', 'description': 'Immune responses after prime and boost vaccinations in cytobrush samples compared to baseline'}], 'primaryOutcomes': [{'measure': 'Incidence of adverse events to measure safety and reactogenicity', 'timeFrame': '3 months for the lead-in and 12 months for the main phase', 'description': 'Measure of adverse events, serious adverse events (SAEs), ≥Grade 3 study vaccine-related adverse events reported.'}], 'secondaryOutcomes': [{'measure': 'Determine the dose of ChAdOx1-HPV plus MVA-HPV vaccines for further development', 'timeFrame': '3 months for lead in phase and 12 months for main phase', 'description': 'Measurement of the highest multi-parameter index made of CD4+ magnitude, CD4+ avidity and CD8+ magnitude at peak timepoint'}, {'measure': 'Determine the effect of ChAdOx1-HPV plus MVA-HPV vaccines on the clearance of high risk HPV infection', 'timeFrame': '12 months for main phase only', 'description': 'The percentage of hrHPV infection clearance'}, {'measure': 'Determine the effect of ChAdOx1-HPV plus MVA-HPV vaccines on cervical intraepithelial neoplasia (CIN)', 'timeFrame': '12 months for main phase only', 'description': 'The percentage of cervical lesions cleared as determined by colposcopy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HPV Infection', 'CIN1']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.\n\nA 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'Participants must have a cervix in order to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Females aged ≥25 and ≤55 years of age at screening.\n2. 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.\n3. Low- grade cervical lesion (CIN1 or HPV-related change only) confirmed by histology and/or cytology report within the 1 year prior to screening.\n4. Not pregnant or breast feeding and one of the following:\n\n * 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)\n * 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:\n\n * 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\n * Hormonal (oral, intravaginal, transdermal, implantable or injectable). Progestogen-only hormonal contraceptives without inhibition of ovulation are not considered to be highly effective.\n * An intrauterine hormone releasing system\n * An intrauterine device\n * Bilateral tubal occlusion\n * Sexual abstinence, only if the participant refrains from heterosexual intercourse during the entire study period and it is the usual lifestyle of the participant\n5. Willing to abstain from sexual activity for 48 hours prior to all swabbing procedures\n\nExclusion Criteria:\n\n1. Presence of any significant acute or chronic, uncontrolled medical (or psychiatric) illness, including blood dyscrasias.\n2. Immunosuppression as a result of underlying illness or treatment including:\n\n * Use of high dose corticosteroids ( \\>10 mg/day prednisone or equivalent) for ≥7 days (inhaled, otic and ophthalmic corticosteroids are permitted)\n * Primary immune deficiency disease\n * Use of synthetic or biologic disease-modifying antirheumatic drugs\n * History of bone marrow or solid organ transplant\n * History of any other clinically significant autoimmune or immunosuppressive disease\n3. Positive diagnostic tests (for human immunodeficiency virus, hepatitis B or hepatitis C) indicating chronic infection.\n4. Evidence of high grade cervical lesions by colposcopy or by Papanicolaou (Pap) smear test in the 1 year prior to screening.\n5. 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.\n6. 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.\n7. 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.\n8. 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.\n9. Current or history of illicit drug use within the 6 months prior to screening.\n10. Current or history of severe alcohol abuse within the 6 months prior to screening.\n11. Any laboratory test which is abnormal and deemed by the Investigator to be clinically significant which will potentially affect the participation in the study.\n12. Current known infection with severe acute respiratory syndrome coronavirus 2 (SARS CoV-2)\n13. Any other finding that, in the opinion of the Investigator, deems the participant unsuitable for the study."}, 'identificationModule': {'nctId': 'NCT04607850', 'briefTitle': 'Prime-boost Vaccine Study in Women With Low-grade Cervical HPV Lesions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Barinthus Biotherapeutics'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'HPV001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lead-in Group A ChAdOx1-HPV low dose and MVA-HPV low dose', 'description': 'Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\\^8 vp) and MVA-HPV (1 x 10\\^7 pfu)', 'interventionNames': ['Biological: ChAdOx1-HPV', 'Biological: MVA-HPV']}, {'type': 'EXPERIMENTAL', 'label': 'Lead-in Group B ChAdOx1-HPV mid dose and MVA-HPV low dose', 'description': 'Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\\^9 vp) and MVA-HPV (1 x 10\\^7 pfu)', 'interventionNames': ['Biological: ChAdOx1-HPV', 'Biological: MVA-HPV']}, {'type': 'EXPERIMENTAL', 'label': 'Lead-in Group C ChAdOx1-HPV high dose and MVA-HPV high dose', 'description': 'Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\\^10) vp and MVA-HPV (1 x 10\\^8 pfu)', 'interventionNames': ['Biological: ChAdOx1-HPV', 'Biological: MVA-HPV']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1 ChAdOx1-HPV mid dose and MVA-HPV low dose', 'description': 'Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\\^9 vp) and MVA-HPV (1 x 10\\^7 pfu)', 'interventionNames': ['Biological: ChAdOx1-HPV', 'Biological: MVA-HPV']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 ChAdOx1-HPV high dose and MVA-HPV low dose', 'description': 'Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\\^10 vp) and MVA-HPV (1 x 10\\^7 pfu)', 'interventionNames': ['Biological: ChAdOx1-HPV', 'Biological: MVA-HPV']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 ChAdOx1-HPV low dose and MVA-HPV high dose', 'description': 'Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\\^8 vp) and MVA-HPV (1 x 10\\^8 pfu)', 'interventionNames': ['Biological: ChAdOx1-HPV', 'Biological: MVA-HPV']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4 ChAdOx1-HPV mid dose and MVA-HPV high dose', 'description': 'Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\\^9 vp) and MVA-HPV (1 x 10\\^8 pfu)', 'interventionNames': ['Biological: ChAdOx1-HPV', 'Biological: MVA-HPV']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5 ChAdOx1-HPV high dose and MVA-HPV high dose', 'description': 'Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\\^10 vp) and MVA-HPV (1 x 10\\^8 pfu)', 'interventionNames': ['Biological: ChAdOx1-HPV', 'Biological: MVA-HPV']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 6 Placebo Saline', 'description': 'Sodium Chloride (0.9%)', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'ChAdOx1-HPV', 'type': 'BIOLOGICAL', 'description': 'Trial vaccine', 'armGroupLabels': ['Group 1 ChAdOx1-HPV mid dose and MVA-HPV low dose', 'Group 2 ChAdOx1-HPV high dose and MVA-HPV low dose', 'Group 3 ChAdOx1-HPV low dose and MVA-HPV high dose', 'Group 4 ChAdOx1-HPV mid dose and MVA-HPV high dose', 'Group 5 ChAdOx1-HPV high dose and MVA-HPV high dose', 'Lead-in Group A ChAdOx1-HPV low dose and MVA-HPV low dose', 'Lead-in Group B ChAdOx1-HPV mid dose and MVA-HPV low dose', 'Lead-in Group C ChAdOx1-HPV high dose and MVA-HPV high dose']}, {'name': 'MVA-HPV', 'type': 'BIOLOGICAL', 'description': 'Trial vaccine', 'armGroupLabels': ['Group 1 ChAdOx1-HPV mid dose and MVA-HPV low dose', 'Group 2 ChAdOx1-HPV high dose and MVA-HPV low dose', 'Group 3 ChAdOx1-HPV low dose and MVA-HPV high dose', 'Group 4 ChAdOx1-HPV mid dose and MVA-HPV high dose', 'Group 5 ChAdOx1-HPV high dose and MVA-HPV high dose', 'Lead-in Group A ChAdOx1-HPV low dose and MVA-HPV low dose', 'Lead-in Group B ChAdOx1-HPV mid dose and MVA-HPV low dose', 'Lead-in Group C ChAdOx1-HPV high dose and MVA-HPV high dose']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Saline placebo vaccine', 'armGroupLabels': ['Group 6 Placebo Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'UZA', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Erasme Hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '80010', 'city': 'Pärnu', 'country': 'Estonia', 'facility': 'Parnu Hospital Womens and Childrens Clinic', 'geoPoint': {'lat': 58.38588, 'lon': 24.49711}}, {'zip': '10119', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'East-Tallinn Central Hospital', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '13419', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'North Estonia Medical Centre Foundation Surgery Clinic', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '51014', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'Tartu University Hospital Womens Clinic', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'BS2 8EG', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'University Hospital Bristol NHS Trust', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'L8 7SS', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': "Liverpool Women's NHS Foundation Trust", 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Royal Victoria Infirmary', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospital NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': "The University of Oxford, Nuffield Department of Women's & Reproductive Health", 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'PR2 9HT', 'city': 'Preston', 'country': 'United Kingdom', 'facility': 'Royal Preston Hospital', 'geoPoint': {'lat': 53.76282, 'lon': -2.70452}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barinthus Biotherapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}