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NCT Number: NCT06681636

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

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Key information

Conditions

HPV Infection Anogenital Cancer Anogenital Warts Cervical Cancer Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases Warts

Age range

18 year–26 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Murdoch Children Research Institute, Parkville, Victoria, Australia

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About this study

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:

  • 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.
  • To compare antibody GMT at 18m and 19m between FSW and non-FSW.
  • To determine cellular immune responses to HPV16 and 18 at baseline, 2m, 7m, 18m and 19m.
  • 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:

  • 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.
  • HPV antibody GMT are similar at 18m and 19m between FSW and non-FSW who received the extended schedule.
  • 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.
  • No new vaccine-type HPV infection in FSW and non-FSW in all groups at 6m, 12m, 18m.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Human papillomavirus 9-valent vaccine, Recombinant

Biological

HPV vaccine manufactured by MSD consisted of 9HPV types: 6,11,16,18,31,33, 45, 52,58

Other names: Gardasil 9

Primary outcomes

  1. Comparison between antibody responses after the 3rd dose ofregular vaccine schedules among FSW and after the 2nd dose of the extended schedule

    Time frame: 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 outcomes

  1. Comparison of antibody responses after each doses among FSW according to HPV infection status pre-vaccination

    Time frame: 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.

  2. Comparison of antibody response after 3 doses of extended schedule between FSW and non-FSW

    Time frame: 19 month after the first doses

    Antibody GMT at 18m and 19m between FSW and non-FSW.

  3. Celular response after each vaccine dose

    Time frame: 19 months after the 1st dose

    Proportion of HPV16 and 18-specific B/T cells at baseline, 2m, 7m, 18m and 19m.

  4. HPV persistent during 19 month or more among vaccines

    Time frame: at least 19 months after the first dose

    • 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Trang V Nguyen, PhD

CONTACT

[email protected]

84902028181

Tuan A Le, MD, PhD

CONTACT

[email protected]

84983738688

Sponsors and collaborators

Lead sponsor

National Institute of Hygiene and Epidemiology, Vietnam

Other

Collaborators

  • CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES
  • Hai Phong Center for Disease Control
  • Murdoch Childrens Research Institute

Registry information

Official study 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

Acronym: HPV9vxFSW

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 8, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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