Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202408538482330 Date of Approval: 06/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts (ABI-2280-401)
Official scientific title A Randomized, Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts
Brief summary describing the background and objectives of the trial Human papillomavirus (HPV) infection is now a well-established cause of cervical cancer and there is growing evidence of HPV being a relevant factor in other anogenital cancers (anus, vulva, vagina and penis) and head and neck cancers. High-risk HPV such as HPV 16, 18 and 12 are responsible for about 70% of all cervical cancer cases worldwide. HPV vaccines that prevent against HPV 16 and 18 infections are now available and have the potential to reduce the incidence of cervical and other anogenital cancers. 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2024
Actual trial start date 27/03/2024
Anticipated date of last follow up 30/04/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Vaginal insert Dose range and dosing regimens in this study will be evaluated through the enrollment of up to 11 sentinel cohorts (including up to 5 optional cohorts), each enrolling up to 8 participants. The optional cohorts may be enrolled in the study at the Sponsor’s discretion based on emerging data from this study and the ABI-2280 program, in case additional dose/regimen ranging or dosing method exploration is indicated. Treatment duration will depend upon the cohort. The total duration of treatment will not exceed 8 weeks from first to last dose (including breaks between treatment cycles). ABI-2280 Vaginal Insert for intravaginal administration. 80
Control Group Vaginal Insert Placebo - no active ingredients. Exactly the same as for the active IP Placebo Vaginal Insert for intravaginal administration. 80 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- 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. - 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. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 55 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/07/2024 KEMRI SERU 501
Ethics Committee Address
Street address City Postal code Country
Off Mbagathi Road, Nairobi Nairobi 54840 002 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/07/2024 KEMRI SERU 503
Ethics Committee Address
Street address City Postal code Country
Off Mbagathi Road, Nairobi Nairobi 54840 002 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome For Sentinel Cohorts: Incidence and Severity of Adverse Events for each dose/dosing regimen. For the duration of the trial.
Primary Outcome Fully Expanded Cohorts including Sentinel: Clearance of persistent cervical hrHPV infection as defined by the absence of all hrHPV genotypes present at baseline. At Week 12
Secondary Outcome Fully Expanded Cohorts including Sentinel: Incidence and Severity of Adverse Events for each dose/dosing regimen. For the duration of the study.
Secondary Outcome Fully Expanded Cohorts including Sentinel: Clearance of persistent cervical hrHPV infection as defined by the absence of all hrHPV genotypes present at baseline. At Week 24
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
International Cancer Institute Nandi Road Eldoret 8088 3010 Kenya
Victoria Cancer Care and Research Centres Kisii Road, Nyamira Nyamira 1376-4050 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Antiva Biosciences Inc 555 Twin Dolphin Drive, Suite 620 Redwood City CA 94065 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Antiva Biosciences Inc 555 Twin Dolphin Drive, Suite 620 Redwood City CA 94065 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
ICON Clinical Research Block 29, Second Floor, The Woodlands, Woodlands Drive Woodmead 2191 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fredrick Chite Asirwa chite@intercancer.com +254768616668 International Cancer institute, Nandi Road Block 8/102
City Postal code Country Position/Affiliation
Eldoret Kenya Principal Investigator
Role Name Email Phone Street address
Principal Investigator Kevin Makori Gesimba kevin.makori@victoriaoncology.com +254795064222 Victoria Cancer Care and Research Centres 1376-40500, Kisii Road
City Postal code Country Position/Affiliation
Nyamira Kenya Principal Investigator
Role Name Email Phone Street address
Public Enquiries Annie Warsi awarsi@antivabio.com +14084016086 555 Twin Dolphin Drive, Suite 620
City Postal code Country Position/Affiliation
Redwood City CA 94065 United States of America Executive Medical Director
Role Name Email Phone Street address
Scientific Enquiries Annie Warsi awarsi@antivabio.com +14084016086 555 Twin Dolphin Drive, Suit 620
City Postal code Country Position/Affiliation
Redwood City CA 94065, CA United States of America Executive Medical Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Progress may be shared at specific intervals or as defined per the protocol after the end of the Study. All collected IPD will be stripped of identifiers and may be made available upon request. Informed Consent Form,Study Protocol After CSR completion at the discretion of sponsor. Access will be controlled by Sponsor.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://www.ClinicalTrials.gov No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/02/2025 Approval letter added TRUE, KEMRI SERU 501, Off Mbagathi Road, Nairobi, Nairobi, 54840 002, Kenya, , 29 Jul 2024, +2540202722541, seru@kemri.org, 30601_29658_4737.pdf TRUE, KEMRI SERU 501, Off Mbagathi Road, Nairobi, Nairobi, 54840 002, Kenya, , 29 Jul 2024, +2540202722541, seru@kemri.org, 30601_29658_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/02/2025 Approval letter added TRUE, KEMRI SERU 503, Off Mbagathi Road, Nairobi, Nairobi, 54840 002, Kenya, , 30 Jul 2024, +2540202722541, seru@kemri.org, 30601_29801_4737.pdf TRUE, KEMRI SERU 503, Off Mbagathi Road, Nairobi, Nairobi, 54840 002, Kenya, , 30 Jul 2024, +2540202722541, seru@kemri.org, 30601_29801_4737.pdf