Human papillomavirus 9-valent vaccine, Recombinant: HPV vaccine manufactured by MSD consisted of 9HPV types: 6,11,16,18,31,33, 45, 52,58
Study 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
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
26 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Comparison between antibody responses after the 3rd dose ofregular vaccine schedules among FSW and after the 2nd dose of the extended schedule — 7 months from the first doses geometric mean titer (GMT) ratios and 95% confidence intervals (CI) of HPV- specific antibody responses to HPV16 and HPV18 at 7m between FSWs aged 18-26 years who received either the standard (0, 2m, 6m) or extended 3-dose (at 0, 6m and 18m) 3-dose 9vHPV schedule and age-matched non-FSWs who received the extended 3-dose 9vHPV schedule (at 0, 6m and 18m).
Trial sites (3)
Facility
City
Region
Status
Murdoch Children Research Institute
Parkville
Victoria
Center for Supporting Community Development Initiatives SCDI-Vietnam
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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