Anogenital Cancer, Anogenital Warts, Cervical Cancer, HPV Infection
Conditions
Keywords
human papillomavirus, HPV vaccine, Vietnam, Female sex workers, immunogenicity, protection, extended schedule, HPV infection, cervical cancer
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.
Interventions
HPV vaccine manufactured by MSD consisted of 9HPV types: 6,11,16,18,31,33, 45, 52,58
Sponsors
Murdoch Childrens Research Institute
CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES
Hai Phong Center for Disease Control
National Institute of Hygiene and Epidemiology, Vietnam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants (FSW groups) will be randomly assigned to either of the vaccine schedules and will be given IDs. The link between participant IDs and vaccine groups are only known by Investigator. Barcodes will be used for samples and no personal identification nor participant ID is allowed in the samples.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 26 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
Countries
Australia, Vietnam
Contacts
Primary ContactTrang V Nguyen, PhD
Backup ContactTuan A Le, MD, PhD
Outcome results
None listed