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Cancer Vaccine

Reduced-Dose HPV Vaccine for Women with HIV (NOVA-HIV Trial)

Phase 3
Recruiting
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 7
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will assess whether two doses of HPV vaccine are as effective as three doses in women living with HIV.

Who is the study for?
This trial is for women aged 18-45 living with HIV in Canada who have a cervix and haven't had an HPV vaccine before. They must be able to consent, not pregnant or agree to avoid pregnancy during the study, and have no allergies to the vaccine ingredients.
What is being tested?
The study tests if two doses of the Nonavalent HPV Vaccine are as effective as three in generating an immune response in women living with HIV. Participants will either follow a routine schedule (0/2/6 months) or an expanded one (0/6 months plus a third dose at month 12).
What are the potential side effects?
While specific side effects aren't listed, vaccines like this can typically cause temporary pain at the injection site, fatigue, headache, muscle or joint pain, fever, nausea or allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anti-HPV16/18 geometric mean titers (GMTs) at month 7

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Extended scheduleExperimental Treatment1 Intervention
Two doses of 9vHPV vaccine at an expanded dosing schedule of 0/6 months with a third dose given at month 12
Group II: Routine scheduleActive Control1 Intervention
Three doses of 9vHPV vaccine at the routine dosing schedule of 0/2/6 months

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,466 Previous Clinical Trials
2,485,006 Total Patients Enrolled

Media Library

Nonavalent HPV vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05495906 — Phase 3
Human Papillomavirus Research Study Groups: Routine schedule, Extended schedule
Human Papillomavirus Clinical Trial 2023: Nonavalent HPV vaccine Highlights & Side Effects. Trial Name: NCT05495906 — Phase 3
Nonavalent HPV vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05495906 — Phase 3
~200 spots leftby Nov 2025
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