Not Yet RecruitingPhase 2

Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure

Australia, Vietnam300 participantsStarted 2024-12-14

Plain-language summary

A Study to evaluate if the 3 dose extended schedule (0-6-18 months) for the HPV vaccine Gardasil-9 provide similar immune responses and short term protection against HPV infection compared to the regular 3 dose schedule (0-2-6 months) in high risk women in Vietnam

Who can participate

Age range

18 Years – 26 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Is between the reporting ages of 18-26 years at the time of recruitment. * Engage in commercial sex in the last 6m (for FSW group) or have engaged in sexual activity (non-FSWs) * Willing and able to give written informed consent. * Willing to complete the follow-up requirements of the study. Exclusion criteria Participants meeting any of the following criteria will be excluded from the trial: * Pregnant or possibly pregnant * Has received any HPV vaccine previously * Has an axillary temperate greater than 38°C * Known allergies to any vaccine component * incapacity to provide consent * Currently receiving immunosuppressive medication or anti-cancer chemotherapy. * Known HIV infection. * Known Congenital immune deficiency syndrome.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comparison between antibody responses after the 3rd dose ofregular vaccine schedules among FSW and after the 2nd dose of the extended schedule

Timeframe: 7 months from the first doses

Trial details

NCT IDNCT06681636

SponsorNational Institute of Hygiene and Epidemiology, Vietnam

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-31

Contact for this trial

Trang V Nguyen, PhD

84902028181 nvt@nihe.org.vn

View on ClinicalTrials.gov More HPV Infection trials