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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 24

Awards & highlights

NOVA-HIV 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.Check my eligibility

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).See study design

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.

NOVA-HIV Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anti-HPV16/18 geometric mean titers (GMTs) at month 7

Secondary outcome measures

Anti-HPV16/18 GMTs at month 24 in both groups (i.e. routine and extended interval)

Quantitative summarization of survey responses regarding vaccine acceptability, comfort, and willingness to use HPV self-sampling as a screening methodology in future

Other outcome measures

Anti-HPV16/18 GMTs at month 6 (one-dose data) in the extended vaccine schedule group

Anti-HPV6/11/31/33/45/52/58 GMTs at month 7 (1 month post 3rd dose in Group 1 and 1 month post 2nd dose in Group 2)

Incidence rates of abnormal cervical cytology and histology, and breakthrough persistent HPV infection

+4 more

NOVA-HIV 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,415 Previous Clinical Trials

2,466,566 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people of all ages participate in this research?

"The age limit for participants in this trial is 45 years old. As long as individuals are over the age of 18, they may be eligible to enroll."

Answered by AI

Would I be able to join this experiment?

"This experiment is looking for 450 people who have HIV and are between 18-45 years old. The most relevant criteria for participants are: a cervix, and being infected with the HIV virus."

Answered by AI

Can new patients still join this clinical trial?

"Data from clinicaltrials.gov reveals that this particular trial is not presently looking for new patients to enroll. The trial was originally announced on September 1st, 2022 and updated last on August 8th, 2022. Even though this study isn't currently recruiting, there are 751 other trials which are still open for enrollment."

Answered by AI

Has the Nonavalent HPV vaccine received its seal of approval from the FDA?

"The Nonavalent HPV vaccine is classified as a 3 in terms of safety. This means that while there is still some testing to be done in regards to its efficacy, the data collected thus far supports its use and multiple rounds have provided evidence for its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Deborah Money 2023. "A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05495906.

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