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HPV InfectionPhase 1/2NCT04607850

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

A Phase 1/2 study testing ChAdOx1-HPV and MVA-HPV in people with HPV Infection and CIN1, run by Barinthus Biotherapeutics at 16 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 55 years, women only
Conditions the study is for
HPV Infection, CIN1
What is being tested?
ChAdOx1-HPV and MVA-HPV
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
16 sitesin 3 countries
Study dates
16 Mar 2021to 16 Jan 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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.
  • Any laboratory test which is abnormal and deemed by the Investigator to be clinically significant which will potentially affect the participation in the study.
  • Current known infection with severe acute respiratory syndrome coronavirus 2 (SARS CoV-2)
  • Any other finding that, in the opinion of the Investigator, deems the participant unsuitable for the study.

Trial locations and contacts

16 sites in 3 countries.

16 sites in 3 countries

United Kingdom7 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • University Hospital Bristol NHS Trust

    Bristol, BS2 8EG

  • Liverpool Women's NHS Foundation Trust

    Liverpool, L8 7SS

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Nottingham University Hospital NHS Trust

    Nottingham, NG5 1PB

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

    Oxford, OX3 9DU

  • Royal Preston Hospital

    Preston, PR2 9HT

Other trials in United Kingdom

Belgium5 sites

  • UZA

    Antwerp, 2650

  • Erasme Hospital

    Brussels, 1070

  • UZ Brussel

    Brussels, 1090

  • UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Estonia4 sites

  • Parnu Hospital Womens and Childrens Clinic

    Pärnu, 80010

  • East-Tallinn Central Hospital

    Tallinn, 10119

  • North Estonia Medical Centre Foundation Surgery Clinic

    Tallinn, 13419

  • Tartu University Hospital Womens Clinic

    Tartu, 51014

Other trials in Estonia

About this study

Official title: 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

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.

Read the detailed 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.

Conditions
HPV Infection, CIN1
Being tested
ChAdOx1-HPV, MVA-HPV, Placebo
Medical subject headings
Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChAdOx1-HPVBiological

    Trial vaccine

  • MVA-HPVBiological

    Trial vaccine

  • PlaceboBiological

    Saline placebo vaccine

Study groups in NCT04607850
Study groupRoleWhat they receive
Lead-in Group A ChAdOx1-HPV low dose and MVA-HPV low doseExperimentalPrime-boost vaccine doses: ChAdOx1-HPV (2 x 10^8 vp) and MVA-HPV (1 x 10^7 pfu)
Receives: Biological: ChAdOx1-HPV; Biological: MVA-HPV
Lead-in Group B ChAdOx1-HPV mid dose and MVA-HPV low doseExperimentalPrime-boost vaccine doses: ChAdOx1-HPV (2 x 10^9 vp) and MVA-HPV (1 x 10^7 pfu)
Receives: Biological: ChAdOx1-HPV; Biological: MVA-HPV
Lead-in Group C ChAdOx1-HPV high dose and MVA-HPV high doseExperimentalPrime-boost vaccine doses: ChAdOx1-HPV (2 x 10^10) vp and MVA-HPV (1 x 10^8 pfu)
Receives: Biological: ChAdOx1-HPV; Biological: MVA-HPV
Group 1 ChAdOx1-HPV mid dose and MVA-HPV low doseExperimentalPrime-boost vaccine doses: ChAdOx1-HPV (2 x 10^9 vp) and MVA-HPV (1 x 10^7 pfu)
Receives: Biological: ChAdOx1-HPV; Biological: MVA-HPV
Group 2 ChAdOx1-HPV high dose and MVA-HPV low doseExperimentalPrime-boost vaccine doses: ChAdOx1-HPV (2 x 10^10 vp) and MVA-HPV (1 x 10^7 pfu)
Receives: Biological: ChAdOx1-HPV; Biological: MVA-HPV
Group 3 ChAdOx1-HPV low dose and MVA-HPV high doseExperimentalPrime-boost vaccine doses: ChAdOx1-HPV (2 x 10^8 vp) and MVA-HPV (1 x 10^8 pfu)
Receives: Biological: ChAdOx1-HPV; Biological: MVA-HPV
Group 4 ChAdOx1-HPV mid dose and MVA-HPV high doseExperimentalPrime-boost vaccine doses: ChAdOx1-HPV (2 x 10^9 vp) and MVA-HPV (1 x 10^8 pfu)
Receives: Biological: ChAdOx1-HPV; Biological: MVA-HPV
Group 5 ChAdOx1-HPV high dose and MVA-HPV high doseExperimentalPrime-boost vaccine doses: ChAdOx1-HPV (2 x 10^10 vp) and MVA-HPV (1 x 10^8 pfu)
Receives: Biological: ChAdOx1-HPV; Biological: MVA-HPV
Group 6 Placebo SalinePlacebo comparatorSodium Chloride (0.9%)
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

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

    Measurement of the highest multi-parameter index made of CD4+ magnitude, CD4+ avidity and CD8+ magnitude at peak timepoint

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

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

    The percentage of hrHPV infection clearance

    Measured: 12 months for main phase only

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

    The percentage of cervical lesions cleared as determined by colposcopy

    Measured: 12 months for main phase only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2020
  2. Study start16 Mar 2021
  3. Primary completion16 Jan 2024
  4. Study completion16 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04607850
Sponsor's protocol ID
HPV001
Status last verified
Aug 2025
First submitted
22 Oct 2020
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hellner K, Simon P, De Sutter P, Vahula KL, Briggs P, Kiisla U, Russell M, Newton C, Dewilde K, Anderson K, Kopycinski J, Vardeu A, Davis C, Sebastian S, Kennerley R, Wheeler V, Jones B, Tait D, Downs M, Dorrell L, Hancock G, Cuschieri K, Evans T. A Phase 1b/2, Randomised, Placebo-controlled Study to Evaluate Safety, Tolerability, Efficacy, and Immunogenicity of VTP-200, a Chimpanzee Adenovirus and Modified Vaccinia Ankara-vectored Multigenotype High-risk Human Papillomavirus Vaccine in Women With Low-grade Cervical Lesions. Clin Infect Dis. 2026 Jul 23;83(1):51-58. doi: 10.1093/cid/ciaf658.

    PubMed 41403292

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ChAdOx1-HPV and MVA-HPV in people with HPV Infection and CIN1, run by Barinthus Biotherapeutics at 16 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United Kingdom, Belgium, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events to measure safety and reactogenicity (time frame: 3 months for the lead-in and 12 months for the main phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04607850, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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