Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure

PHASE2NOT_YET_RECRUITING

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.

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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.

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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.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : Yes

    Gender eligible for study: Female

    Things to know

    Study dates

    Study start: 2024-12-14

    Primary completion: 2026-10-31

    Study completion finish: 2027-12-31

    study type

    Study type

    PREVENTION

    phase

    Phase

      PHASE2

    trial

    Trial ID

    NCT06681636

    Intervention or treatment

    BIOLOGICAL: Human papillomavirus 9-valent vaccine, Recombinant

    Conditions

    • Cervical Cancer
    • HPV Infection
    • Anogenital Cancer
    • Anogenital Warts
    Image related to Cervical Cancer
    • Condition: Cervical Cancer, HPV Infection and more

    • BIOLOGICAL: Human papillomavirus 9-valent vaccine, Recombinant

    • Parkville, Victoria, Australia

    • Sponsor: National Institute of Hygiene and Epidemiology, Vietnam

    Find a site

    Closest Location:

    Murdoch Children Research Institute

    Research sites nearby

    Select from list below to view details:

    • Murdoch Children Research Institute

      Parkville, Victoria, Australia

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    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/ArmIntervention/Treatment
    EXPERIMENTAL: Group 1 FSW
    • 100 FSWs aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months
    BIOLOGICAL: Human papillomavirus 9-valent vaccine, Recombinant
    • HPV vaccine manufactured by MSD consisted of 9HPV types: 6,11,16,18,31,33, 45, 52,58
    ACTIVE_COMPARATOR: Group 2 non-FSW
    • 100 non-FSW aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months
    BIOLOGICAL: Human papillomavirus 9-valent vaccine, Recombinant
    • HPV vaccine manufactured by MSD consisted of 9HPV types: 6,11,16,18,31,33, 45, 52,58
    ACTIVE_COMPARATOR: Group 3 FSW
    • 100 FSW aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-2-6 months
    BIOLOGICAL: Human papillomavirus 9-valent vaccine, Recombinant
    • HPV vaccine manufactured by MSD consisted of 9HPV types: 6,11,16,18,31,33, 45, 52,58

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Comparison between antibody responses after the 3rd dose ofregular vaccine schedules among FSW and after the 2nd dose of the extended schedulegeometric 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

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Comparison of antibody responses after each doses among FSW according to HPV infection status pre-vaccinationAntibody 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-FSWAntibody GMT at 18m and 19m between FSW and non-FSW.19 month after the first doses
    Celular response after each vaccine doseProportion 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 vaccines4. 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

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    References

    Clinical Trials Gov: Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure

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