Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure
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.
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
- 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
PREVENTION
Phase
- PHASE2
Study ID
NCT06681636
Intervention or treatment
BIOLOGICAL: Human papillomavirus 9-valent vaccine, Recombinant
Conditions
- HPV Infection
- Cervical Cancer
- Anogenital Cancer
- Anogenital Warts
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Research sites nearby
Closest Location:
Murdoch Children Research Institute
Select from list below to view details:
Murdoch Children Research Institute
Parkville, Victoria, Australia
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Who is running the clinical trial?
National Institute of Hygiene and Epidemiology, Vietnam
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Group 1 FSW
| Biological: Human papillomavirus 9-valent vaccine, Recombinant |
ACTIVE_COMPARATOR: Group 2 non-FSW
| Biological: Human papillomavirus 9-valent vaccine, Recombinant |
ACTIVE_COMPARATOR: Group 3 FSW
| Biological: Human papillomavirus 9-valent vaccine, Recombinant |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 7 months from the first doses |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 19 months after the 1st doses |
| 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. | 19 month after the first doses |
| Celular response after each vaccine dose | Proportion of HPV16 and 18-specific B/T cells at baseline, 2m, 7m, 18m and 19m. | 19 months after the 1st dose |
| 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). | at least 19 months after the first dose |
References
Clinical Trials Gov: Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus ExposureOther trials to consider
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