Clinical trial NCT06681636: Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure
Official title: A Non-inferiority Study Comparing the Immunogenicity of a Standard or an Extended Three-dose Nonavalent Human Papillomavirus Vaccine Schedule Between High-risk Women Aged 18-26 Years and Age-matched Women in the General Population
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: HPV Infection
Cervical Cancer
Anogenital Cancer
Anogenital Warts
Keywords: human papillomavirus
HPV vaccine
Vietnam
Female sex workers
immunogenicity
protection
extended schedule
HPV infection
cervical cancer
Lead sponsor: National Institute of Hygiene and Epidemiology, Vietnam
Sponsor class: OTHER
Collaborators: name: Murdoch Childrens Research Institute
name: CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES
name: Hai Phong Center for Disease Control
First posted: 2024-11-08
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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 outcomes:
measure: 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
Secondary outcomes:
measure: Comparison of antibody responses after each doses among FSW according to HPV infection status pre-vaccination
timeFrame: 19 months after the 1st doses
measure: Comparison of antibody response after 3 doses of extended schedule between FSW and non-FSW
timeFrame: 19 month after the first doses
measure: Celular response after each vaccine dose
timeFrame: 19 months after the 1st dose
measure: HPV persistent during 19 month or more among vaccines
timeFrame: at least 19 months after the first dose
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Murdoch Children Research Institute
state: Victoria
city: Hai Phong
country: Vietnam
facility: Center for Supporting Community Development Initiatives SCDI-Vietnam
city: Hai Phong
country: Vietnam
facility: Hai Phong Center for Disease Control
Study officials:
affiliation: National Institute of Hygiene and Epidemiology, Vietnam
name: Hong T Duong, MD, PhD
role: STUDY_DIRECTOR
affiliation: National Institute of Hygiene and Epidemiology, Vietnam
name: Trang V Nguyen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Hygiene and Epidemiology, Vietnam
name: Tuan A Le, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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