A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living

Status Recruiting

Clinical Trial Summary

There are very little data on human papillomavirus (HPV) vaccination among the 18 million women living with HIV (WLWH) globally, who constitute a population most vulnerable to HPV and the resultant cervical cancer. Particularly, there are no data to date on reduced-dose schedules of nonavalent HPV (9vHPV) vaccination in WLWH and there are very little data on the 9vHPV vaccine in this population overall. It is critical to examine the 9vHPV vaccine in WLWH now because the quadrivalent HPV (4vHPV) vaccine has been discontinued. Additionally, in order to reach the World Health Organization's global goal of cervical cancer elimination, we must determine the role of various HPV prevention strategies in this important population including reduced vaccine dosing which can drastically increase the feasibility of HPV vaccination programs globally. This randomized clinical trial will enrol WLWH aged 18-45 from across Canada who have not previously received an HPV vaccine. Participants will be randomized 1:1 to receive 3 doses of 9vHPV vaccine at the routine vaccine schedule of 0/2/6 months or 2 doses at an expanded schedule of 0/6 months with a third dose at month 12 to adhere to current recommendations for WLWH. We will compare the immune response generated to two versus three doses of 9vHPV vaccine and will follow participants for 2 years to examine the immune response over time. This study, which builds upon our team's prior work on HPV vaccination in WLWH, will determine whether two doses of 9vHPV vaccine can be used in WLWH instead of three, and will examine additional aspects of HPV vaccination in WLWH including the immune response to three doses, vaccine safety and efficacy, and attitudes towards self-collected HPV samples in this population. These data will inform global public health policy and programming and will inform the global strategy for cervical cancer elimination.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05495906
Study type	Interventional
Source	University of British Columbia
Contact	Deborah Money, MD
Phone	6048752194
Email	deborah.money@ubc.ca
Status	Recruiting
Phase	Phase 3
Start date	July 27, 2023
Completion date	August 2026

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03516318` - Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria	N/A
Completed	`NCT04653194` - Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'	Phase 3
Completed	`NCT01792570` - DRV/r + RPV QD: Efficacy and Toxicity Reduction	Phase 3
Active, not recruiting	`NCT04826562` - Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)	Phase 4
Completed	`NCT04191967` - Thermocoagulation for Treatment of Precancerous Cervical Lesions	N/A
Completed	`NCT02812329` - Intervention to Encourage HIV Testing and Counseling Among Adolescents	Phase 1
Completed	`NCT02919306` - Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults	Phase 1/Phase 2
Completed	`NCT02516930` - A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China	N/A
Completed	`NCT02651376` - Safety and Efficacy of Allogenic Adoptive Immune Therapy for Advanced AIDS Patients	Phase 1/Phase 2
Recruiting	`NCT02392884` - HIV Medication Adherence in Underserved Populations	N/A
Completed	`NCT01944371` - Short-term Disulfiram Administration to Reverse Latent HIV Infection: a Dose Escalation Study	Phase 1/Phase 2
Recruiting	`NCT01778374` - Mater-Bronx Rapid HIV Testing Project.	N/A
Completed	`NCT00914225` - Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya	N/A
Completed	`NCT01490346` - Tissue Drug Levels of HIV Medications	N/A
Completed	`NCT01076179` - Kaletra in Combination With Antiretroviral Agents	N/A
Completed	`NCT01460433` - Problems With Immune Recovery in the Gut Tissue	N/A
Completed	`NCT00317460` - Buprenorphine and Integrated HIV Care	Phase 4
Terminated	`NCT04240210` - Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita)	Phase 4
Active, not recruiting	`NCT04704336` - Integration of Hypertension Management Into HIV Care in Nigeria	N/A
Completed	`NCT03254277` - 3BNC117-LS First-in-Human Phase 1 Study	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV — NOVA-HIV

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms