NCT04607850

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2021

Typical duration for phase_1

Geographic Reach
3 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2024

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

2.8 years

First QC Date

October 22, 2020

Last Update Submit

August 21, 2025

Conditions

HPV InfectionCIN1

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events to measure safety and reactogenicity

    Measure of adverse events, serious adverse events (SAEs), ≥Grade 3 study vaccine-related adverse events reported.

    3 months for the lead-in and 12 months for the main phase

Secondary Outcomes (3)

  • Determine the dose of ChAdOx1-HPV plus MVA-HPV vaccines for further development

    3 months for lead in phase and 12 months for main phase

  • Determine the effect of ChAdOx1-HPV plus MVA-HPV vaccines on the clearance of high risk HPV infection

    12 months for main phase only

  • Determine the effect of ChAdOx1-HPV plus MVA-HPV vaccines on cervical intraepithelial neoplasia (CIN)

    12 months for main phase only

Other Outcomes (4)

  • Assess the complex cellular immune response generated by ChAdOx1-HPV plus MVA-HPV vaccines

    3 months for lead in phase and 12 months for main phase

  • Assess the complex cellular immune response generated by ChAdOx1-HPV plus MVA-HPV vaccines

    3 months for lead in phase and 12 months for main phase

  • Assess the complex cellular immune response generated by ChAdOx1-HPV plus MVA-HPV vaccines

    3 months for lead in phase and 12 months for main phase

  • +1 more other outcomes

Study Arms (9)

Lead-in Group A ChAdOx1-HPV low dose and MVA-HPV low dose

EXPERIMENTAL

Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^8 vp) and MVA-HPV (1 x 10\^7 pfu)

Biological: ChAdOx1-HPVBiological: MVA-HPV

Lead-in Group B ChAdOx1-HPV mid dose and MVA-HPV low dose

EXPERIMENTAL

Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^9 vp) and MVA-HPV (1 x 10\^7 pfu)

Biological: ChAdOx1-HPVBiological: MVA-HPV

Lead-in Group C ChAdOx1-HPV high dose and MVA-HPV high dose

EXPERIMENTAL

Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^10) vp and MVA-HPV (1 x 10\^8 pfu)

Biological: ChAdOx1-HPVBiological: MVA-HPV

Group 1 ChAdOx1-HPV mid dose and MVA-HPV low dose

EXPERIMENTAL

Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^9 vp) and MVA-HPV (1 x 10\^7 pfu)

Biological: ChAdOx1-HPVBiological: MVA-HPV

Group 2 ChAdOx1-HPV high dose and MVA-HPV low dose

EXPERIMENTAL

Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^10 vp) and MVA-HPV (1 x 10\^7 pfu)

Biological: ChAdOx1-HPVBiological: MVA-HPV

Group 3 ChAdOx1-HPV low dose and MVA-HPV high dose

EXPERIMENTAL

Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^8 vp) and MVA-HPV (1 x 10\^8 pfu)

Biological: ChAdOx1-HPVBiological: MVA-HPV

Group 4 ChAdOx1-HPV mid dose and MVA-HPV high dose

EXPERIMENTAL

Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^9 vp) and MVA-HPV (1 x 10\^8 pfu)

Biological: ChAdOx1-HPVBiological: MVA-HPV

Group 5 ChAdOx1-HPV high dose and MVA-HPV high dose

EXPERIMENTAL

Prime-boost vaccine doses: ChAdOx1-HPV (2 x 10\^10 vp) and MVA-HPV (1 x 10\^8 pfu)

Biological: ChAdOx1-HPVBiological: MVA-HPV

Group 6 Placebo Saline

PLACEBO COMPARATOR

Sodium Chloride (0.9%)

Biological: Placebo

Interventions

ChAdOx1-HPVBIOLOGICAL

Trial vaccine

Group 1 ChAdOx1-HPV mid dose and MVA-HPV low doseGroup 2 ChAdOx1-HPV high dose and MVA-HPV low doseGroup 3 ChAdOx1-HPV low dose and MVA-HPV high doseGroup 4 ChAdOx1-HPV mid dose and MVA-HPV high doseGroup 5 ChAdOx1-HPV high dose and MVA-HPV high doseLead-in Group A ChAdOx1-HPV low dose and MVA-HPV low doseLead-in Group B ChAdOx1-HPV mid dose and MVA-HPV low doseLead-in Group C ChAdOx1-HPV high dose and MVA-HPV high dose
MVA-HPVBIOLOGICAL

Trial vaccine

Group 1 ChAdOx1-HPV mid dose and MVA-HPV low doseGroup 2 ChAdOx1-HPV high dose and MVA-HPV low doseGroup 3 ChAdOx1-HPV low dose and MVA-HPV high doseGroup 4 ChAdOx1-HPV mid dose and MVA-HPV high doseGroup 5 ChAdOx1-HPV high dose and MVA-HPV high doseLead-in Group A ChAdOx1-HPV low dose and MVA-HPV low doseLead-in Group B ChAdOx1-HPV mid dose and MVA-HPV low doseLead-in Group C ChAdOx1-HPV high dose and MVA-HPV high dose
PlaceboBIOLOGICAL

Saline placebo vaccine

Group 6 Placebo Saline

Eligibility Criteria

Age25 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must have a cervix in order to participate.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • Sexual abstinence, only if the participant refrains from heterosexual intercourse during the entire study period and it is the usual lifestyle of the participant
  • Willing to abstain from sexual activity for 48 hours prior to all swabbing procedures

You may not qualify if:

  • 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 C) indicating chronic infection.
  • Evidence of high grade cervical lesions by colposcopy or by Papanicolaou (Pap) smear test in the 1 year prior to screening.
  • 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 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.
  • 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.
  • 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.
  • Current or history of severe alcohol abuse within the 6 months prior to screening.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

UZA

Antwerp, 2650, Belgium

Location

Erasme Hospital

Brussels, 1070, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Parnu Hospital Womens and Childrens Clinic

Pärnu, 80010, Estonia

Location

East-Tallinn Central Hospital

Tallinn, 10119, Estonia

Location

North Estonia Medical Centre Foundation Surgery Clinic

Tallinn, 13419, Estonia

Location

Tartu University Hospital Womens Clinic

Tartu, 51014, Estonia

Location

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

University Hospital Bristol NHS Trust

Bristol, BS2 8EG, United Kingdom

Location

Liverpool Women's NHS Foundation Trust

Liverpool, L8 7SS, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Nottingham University Hospital NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

The University of Oxford, Nuffield Department of Women's & Reproductive Health

Oxford, OX3 9DU, United Kingdom

Location

Royal Preston Hospital

Preston, PR2 9HT, United Kingdom

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Lead in phase will be open label. Main phase and expansion phase will be blinded.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 29, 2020

Study Start

March 16, 2021

Primary Completion

January 16, 2024

Study Completion

January 16, 2024

Last Updated

August 28, 2025

Record last verified: 2025-08

Locations

GB(7)BE(5)ES(4)