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
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.
Pregnant or possibly pregnant
Has received any HPV vaccine previously
Has an axillary temperate greater than 38°C
Known allergies to any vaccine component
Parallel
Human papillomavirus 9-valent vaccine, Recombinant
Biological/VaccineHPV vaccine manufactured by MSD consisted of 9HPV types: 6,11,16,18,31,33, 45, 52,58
Comparison between antibody responses after the 3rd dose ofregular vaccine schedules among FSW and after the 2nd dose of the extended schedule
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).
Comparison of antibody responses after each doses among FSW according to HPV infection status pre-vaccination
Antibody GMT at 2m, 7m, 18m and 19m between FSW who are HPV DNA+/seropositive with FSW who are HPV DNA-/seronegative at baseline.
Comparison of antibody response after 3 doses of extended schedule between FSW and non-FSW
Antibody GMT at 18m and 19m between FSW and non-FSW.
Celular response after each vaccine dose
Proportion of HPV16 and 18-specific B/T cells at baseline, 2m, 7m, 18m and 19m.
HPV persistent during 19 month or more among vaccines
4\. Incidence (detection of the specific-type HPV DNA at least once during the follow-up period) and persistent HPV infection (defined as detection of the same HPV type in at least 2 samples not interrupted by negative sample during the follow-up period).
Click on the lead sponsor to view all of their trials.
National Institute of Hygiene and Epidemiology, Vietnam
Lead sponsor
Murdoch Childrens Research Institute
Collaborator
CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES
Collaborator
Hai Phong Center for Disease Control
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
