Human Papillomavirus InfectionPhase 1/2NCT06491446
Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts
A Phase 1/2 study testing ABI-2280 in people with Human Papillomavirus Infection, run by Antiva Biosciences at 24 sites in 4 countries.
Trial summary
This is a blinded study to assess safety, tolerability, and efficacy of ABI-2280 vaginal inserts in participants diagnosed with persistent cervical hrHPV infection. This study will have up to 11 cohorts with various dose strengths and regimens. Each cohort will start with a sentinel cohort of 8 participants. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women only
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- ABI-2280
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 27 Mar 2024to 20 Apr 2026
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
Australia8 sites
PARC Clinical Research, Royal Adelaide Hospital
Adelaide, South Australia
Emeritus Research Camberwell
Camberwell
Holdsworth House Medical Practice
Darlinghurst
KIMR
Nedlands
The Royal Women's Hospital
Parkville
Emeritus Research Sydney
Sydney
AusTrials Taringa
Taringa
AusTrials Wellers Hill
Tarragindi
New Zealand8 sites
Waitemata Clinical Research Ltd
Birkenhead
P3 Research Dunedin
Dunedin
P3 Research Hawke's Bay
Hastings
P3 Research Lower Hutt
Lower Hutt
Pacific Clinical Trials Network - Tasman
Nelson
P3 Research Kapiti
Paraparaumu
Lakeland Clinical Trials
Rotorua
Clinical Horizons New Zealand
Tauranga
Kenya4 sites
International Cancer Institute
Eldoret, 8088-30100
Victoria Cancer Care & Research Centres
Kisii, 1376-40500
Kenya Medical Research Institute (KEMRI) - RCTP Kisumu
Kisumu, 614-40100
Victoria Biomedical Research Institute
Kisumu, 7180-40100
Mexico4 sites
Arke Estudios Clinicos S.A. De C.V.
Cuauhtémoc, CP 06700
Centro Oncologico Internacional
Mexico City, CP 04700
Unidad de Medicina Especializada SMA
Querétaro, CP 76800
FAICIC S. de R.L. de C.V.
Veracruz, CP 91900
About this study
Official title: A Randomized, Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts
This is a blinded study to assess safety, tolerability, and efficacy of ABI-2280 vaginal inserts in participants diagnosed with persistent cervical hrHPV infection. This study will have up to 11 cohorts with various dose strengths and regimens. Each cohort will start with a sentinel cohort of 8 participants. Sentinel cohorts may be expanded to include an additional up to 32 participants to provide additional proof of concept data to further understanding of benefit/risk of a given dose/dose regimen.
Read the detailed description
This is a randomized, double-blind, placebo-controlled Phase 1b/2 study in women diagnosed with persistent cervical hrHPV infection. This study is designed to assess safety, tolerability, and efficacy following the use of ABI-2280 Vaginal Insert delivered intravaginally. Sentinel cohorts will be utilized to assess tolerable regimens, which may trigger cohort expansions if some evidence of efficacy is observed.
Dose range and dosing regimens in this study will be evaluated through the enrollment of up to 11 sentinel cohorts, each enrolling up to 8 participants.
- Conditions
- Human Papillomavirus Infection
- Being tested
- ABI-2280
- Keywords
- HPV, sexually-transmitted infection, high-risk HPV, CIN
- Medical subject headings
- Papillomavirus Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-2280Drug
Different strength of ABI 2280 will be administered in different cohorts.
Other: Placebo Matching placebo will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Cohort 1 | Active comparator | Participants in this arm will receive either ABI 2280 (Dose 1) or matching placebo Receives: Drug: ABI-2280 |
| Experimental: Cohort 2 | Active comparator | Participants in this arm will receive either ABI 2280 (Dose 2) or matching placebo Receives: Drug: ABI-2280 |
| Experimental: Cohort 3 | Active comparator | Participants in this arm will receive either ABI 2280 (Dose 3) or matching placebo Receives: Drug: ABI-2280 |
| Experimental: Cohort 4 | Active comparator | Participants in this arm will receive either ABI 2280 (Dose 4) or matching placebo Receives: Drug: ABI-2280 |
| Experimental: Cohort 5 | Active comparator | Participants in this arm will receive either ABI 2280 (Dose 5) or matching placebo Receives: Drug: ABI-2280 |
| Experimental: Cohort 6 | Active comparator | Participants in this arm will receive either ABI 2280 (Dose 6) or matching placebo Receives: Drug: ABI-2280 |
| Experimental: Cohort 7 | Active comparator | Participants in this arm will receive either ABI 2280 (Dose 7) or matching placebo Receives: Drug: ABI-2280 |
| Experimental: Cohort 8 | Active comparator | Participants in this arm will receive either ABI 2280 (Dose 8) or matching placebo Receives: Drug: ABI-2280 |
| Experimental: Cohort 9 | Active comparator | Participants in this arm will receive either ABI 2280 (Dose 9) or matching placebo Receives: Drug: ABI-2280 |
| Experimental: Cohort 10 | Active comparator | Participants in this arm will receive either ABI 2280 (Dose 10) or matching placebo Receives: Drug: ABI-2280 |
| Experimental: Cohort 11 | Active comparator | Participants in this arm will receive either ABI 2280 (Dose 11) or matching placebo Receives: Drug: ABI-2280 |
What is being measured
The primary outcome is the main question the study is designed to answer.
For sentinel cohorts: Incidence and Severity of Adverse Events
For sentinel cohorts: for each dose/dosing regimen, incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo
Measured: Week 24
For fully expanded cohorts, including sentinel: Clearance of persistent cervical hrHPV infection as defined by the absence of all hrHPV genotypes present at baseline
Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders.
Measured: Week 12
Secondary outcomes (2)
For fully expanded cohorts, including sentinel: Incidence and Severity of Adverse Events
For fully expanded cohorts, including sentinel: for each dose/dosing regimen, incidence and severity of AEs, relationship of AEs to IP, and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo.
Measured: Week 24
Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders
For fully expanded cohorts, including sentinel: For each dose/dosing regimen, proportion of participants who received ABI-2280 Vaginal Insert vs. pooled placebo who are complete responders, defined as the absence of all hrHPV genotypes that were present at baseline, at Week 24
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start27 Mar 2024
- Primary completion17 Oct 2025
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antiva Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491446
- Sponsor's protocol ID
- ABI-2280-401
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts
- ClinicalTrials.gov ID
- NCT06491446
- Acronym / sponsor ID
- ABI-2280-401
- Conditions
- Human Papillomavirus Infection
- Keywords
- HPV, sexually-transmitted infection, high-risk HPV, CIN
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Antiva BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a blinded study to assess safety, tolerability, and efficacy of ABI-2280 vaginal inserts in participants diagnosed with persistent cervical hrHPV infection. This study will have up to 11 cohorts with various dose strengths and regimens. Each cohort will start with a sentinel cohort of 8 participants. Sentinel cohorts may be expanded to include an additional up to 32 participants to provide additional proof of concept data to further understanding of benefit/risk of a given dose/dose regimen.
Detailed description
This is a randomized, double-blind, placebo-controlled Phase 1b/2 study in women diagnosed with persistent cervical hrHPV infection. This study is designed to assess safety, tolerability, and efficacy following the use of ABI-2280 Vaginal Insert delivered intravaginally. Sentinel cohorts will be utilized to assess tolerable regimens, which may trigger cohort expansions if some evidence of efficacy is observed.
Dose range and dosing regimens in this study will be evaluated through the enrollment of up to 11 sentinel cohorts, each enrolling up to 8 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Experimental: Cohort 1 | Active comparator | Drug: ABI-2280Participants in this arm will receive either ABI 2280 (Dose 1) or matching placebo |
| Experimental: Cohort 2 | Active comparator | Drug: ABI-2280Participants in this arm will receive either ABI 2280 (Dose 2) or matching placebo |
| Experimental: Cohort 3 | Active comparator | Drug: ABI-2280Participants in this arm will receive either ABI 2280 (Dose 3) or matching placebo |
| Experimental: Cohort 4 | Active comparator | Drug: ABI-2280Participants in this arm will receive either ABI 2280 (Dose 4) or matching placebo |
| Experimental: Cohort 5 | Active comparator | Drug: ABI-2280Participants in this arm will receive either ABI 2280 (Dose 5) or matching placebo |
| Experimental: Cohort 6 | Active comparator | Drug: ABI-2280Participants in this arm will receive either ABI 2280 (Dose 6) or matching placebo |
| Experimental: Cohort 7 | Active comparator | Drug: ABI-2280Participants in this arm will receive either ABI 2280 (Dose 7) or matching placebo |
| Experimental: Cohort 8 | Active comparator | Drug: ABI-2280Participants in this arm will receive either ABI 2280 (Dose 8) or matching placebo |
| Experimental: Cohort 9 | Active comparator | Drug: ABI-2280Participants in this arm will receive either ABI 2280 (Dose 9) or matching placebo |
| Experimental: Cohort 10 | Active comparator | Drug: ABI-2280Participants in this arm will receive either ABI 2280 (Dose 10) or matching placebo |
| Experimental: Cohort 11 | Active comparator | Drug: ABI-2280Participants in this arm will receive either ABI 2280 (Dose 11) or matching placebo |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABI-2280Different strength of ABI 2280 will be administered in different cohorts. Other: Placebo Matching placebo will be administered. | Drug | Experimental: Cohort 1, Experimental: Cohort 10, Experimental: Cohort 11, Experimental: Cohort 2, Experimental: Cohort 3, Experimental: Cohort 4, Experimental: Cohort 5, Experimental: Cohort 6, Experimental: Cohort 7, Experimental: Cohort 8, Experimental: Cohort 9 |
Primary outcome
For sentinel cohorts: Incidence and Severity of Adverse Events
Time frame: Week 24
For sentinel cohorts: for each dose/dosing regimen, incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo
For fully expanded cohorts, including sentinel: Clearance of persistent cervical hrHPV infection as defined by the absence of all hrHPV genotypes present at baseline
Time frame: Week 12
Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders.
2 secondary outcomes
For fully expanded cohorts, including sentinel: Incidence and Severity of Adverse Events
Time frame: Week 24
Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders
Time frame: Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ABI-2280 in people with Human Papillomavirus Infection, run by Antiva Biosciences at 24 sites in 4 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 3 inclusion and 4 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Australia, New Zealand, Kenya, Mexico. 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. 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?
For sentinel cohorts: Incidence and Severity of Adverse Events (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.