CompletedPhase 1/2

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

Belgium108 participantsStarted 2021-03-16

Plain-language 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.

Who can participate

Age range25 Years – 55 Years

SexFEMALE

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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:
✓. Willing to abstain from sexual activity for 48 hours prior to all swabbing procedures

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:
✕. 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.

What they're measuring

Incidence of adverse events to measure safety and reactogenicity

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

Trial details

NCT IDNCT04607850

SponsorBarinthus Biotherapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-16

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