Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure
- Conditions
- HPV InfectionCervical CancerAnogenital CancerAnogenital Warts
- Interventions
- Registration Number
- NCT06681636
- Lead Sponsor
- National Institute of Hygiene and Epidemiology, Vietnam
- Brief 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
- Detailed Description
Primary objective:
To determine whether antibody geometric mean titer (GMT) to vaccine type HPV16 and HPV18 at 7 months (m) are non-inferior between female sex workers (FSW) aged 18-26 years who received the standard (0, 2m, 6m) and those received the extended 3-dose (at 0, 6m and 18m) 9vHPV schedule and age-matched non-FSW who received an extended 3-dose (at 0, 6m and 18m) 9vHPV schedule. This extended 3-dose schedule is in line with the recommended schedule by the vaccine manufacturer in Vietnam.
Secondary objectives:
1. To compare antibody GMT at 2m, 7m, 18m and 19m between FSW who are HPV DNA+/seropositive with FSW who are HPV DNA-/seronegative at baseline.
2. To compare antibody GMT at 18m and 19m between FSW and non-FSW.
3. To determine cellular immune responses to HPV16 and 18 at baseline, 2m, 7m, 18m and 19m.
4. To measure incidence and 6m/12m/18m persistent HPV infection.
Primary hypothesis:
HPV antibody GMT to HPV16 and 18 in FSW is non-inferior to those of young women of the same age group (non-FSW) at 7m.
Secondary hypothesis:
1. HPV antibody GMT are similar at 2m, 7m, 18m and 19m between FSW who are HPV DNA+/seropositive and HPV DNA-/seronegative at month 0.
2. HPV antibody GMT are similar at 18m and 19m between FSW and non-FSW who received the extended schedule.
3. Cellular immune responses to HPV16 and 18 are similar between FSW and non-FSW at 2m, 7m, 18m and 19m who received the extended schedule.
4. No new vaccine-type HPV infection in FSW and non-FSW in all groups at 6m, 12m, 18m.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 FSW Human papillomavirus 9-valent vaccine, Recombinant 100 FSWs aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months Group 3 FSW Human papillomavirus 9-valent vaccine, Recombinant 100 FSW aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-2-6 months Group 2 non-FSW Human papillomavirus 9-valent vaccine, Recombinant 100 non-FSW aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method Celular response after each vaccine dose 19 months after the 1st dose Proportion of HPV16 and 18-specific B/T cells at baseline, 2m, 7m, 18m and 19m.
Comparison of antibody responses after each doses among FSW according to HPV infection status pre-vaccination 19 months after the 1st doses 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 19 month after the first doses Antibody GMT at 18m and 19m between FSW and non-FSW.
HPV persistent during 19 month or more among vaccines at least 19 months after the first dose 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).
Trial Locations
- Locations (3)
Murdoch Children Research Institute
🇦🇺Parkville, Victoria, Australia
Center for Supporting Community Development Initiatives SCDI-Vietnam
🇻🇳Hai Phong, Vietnam
Hai Phong Center for Disease Control
🇻🇳Hai Phong, Vietnam
Murdoch Children Research Institute🇦🇺Parkville, Victoria, Australia