Evaluating a new vaginal insert for clearing high-risk HPV

A Randomized, Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts

This study is testing a new vaginal insert to see if it can help women with persistent high-risk HPV infections clear the virus safely and effectively.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 25 Years to 55 Years
• Sex: Female
• Sponsor: Antiva Biosciences (Industry-sponsored)
• Locations: 16 sites (Adelaide, South Australia and 15 other locations)
• Trial ID: NCT06491446 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, double-blind, placebo-controlled study assessing the safety, tolerability, and efficacy of ABI-2280 vaginal inserts in women diagnosed with persistent cervical high-risk HPV infection. The study will involve up to 11 cohorts, starting with sentinel cohorts of 8 participants each, which may be expanded based on initial findings. Participants will receive varying doses of the vaginal insert to determine the most effective regimen while monitoring for any adverse effects.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 25 to 55 with a confirmed diagnosis of persistent cervical high-risk HPV infection.

Not a fit: Patients with a history of high-grade cervical lesions or cervical cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for women to clear high-risk HPV infections and reduce the risk of cervical cancer.

How similar studies have performed: While this approach is novel, similar studies targeting HPV clearance have shown promise in the past.

Eligibility criteria

Inclusion Criteria

* Female sex, 25 to 55 years of age
* Positive hrHPV result on at least 2 consecutive tests prior to randomization, one hrHPV+ result at least 12 months prior to screening
* Cervical cytology, colposcopy and/or biopsy performed within the last 6 months confirming disease status no greater than low-grade squamous intraepithelial lesions or cervical intraepithelial neoplasia grade 1.

Exclusion Criteria

* History of biopsy or colposcopy indicating high-grade squamous intraepithelial lesions, or history of endocervical curettage positive for glandular dysplasia
* Any clinically significant immune suppressing condition
* History or current diagnosis of cervical cancer, suspected or confirmed
* Plan to have excision or ablation of cervical or vaginal lesions, or to undergo large loop excision of the transformation zone at any time during the study.

Where this trial is running

Adelaide, South Australia and 15 other locations

• PARC Clinical Research, Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
• Emeritus Research Camberwell — Camberwell, Australia (Recruiting)
• Holdsworth House Medical Practice — Darlinghurst, Australia (Recruiting)
• Kimr — Nedlands, Australia (Recruiting)
• The Royal Women's Hospital — Parkville, Australia (Not_yet_recruiting)
• Emeritus Research Sydney — Sydney, Australia (Recruiting)
• AusTrials Taringa — Taringa, Australia (Recruiting)
• AusTrials Wellers Hill — Tarragindi, Australia (Recruiting)
• Waitemata Clinical Research Ltd — Birkenhead, New Zealand (Recruiting)
• P3 Research Dunedin — Dunedin, New Zealand (Recruiting)
• P3 Research Hawke's Bay — Hastings, New Zealand (Recruiting)
• P3 Research Lower Hutt — Lower Hutt, New Zealand (Recruiting)
• Pacific Clinical Trials Network - Tasman — Nelson, New Zealand (Recruiting)
• P3 Research Kapiti — Paraparaumu, New Zealand (Recruiting)
• Lakeland Clinical Trials — Rotorua, New Zealand (Recruiting)
• Clinical Horizons New Zealand — Tauranga, New Zealand (Recruiting)

Study contacts

• Study coordinator: Ann Warsi

Conditions Human Papillomavirus Infection; HPV; sexually-transmitted infection; high-risk HPV; CIN