Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure (HPV9vxFSW)

November 7, 2024 updated by: Nguyen Van Trang, National Institute of Hygiene and Epidemiology, Vietnam

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trang V Nguyen, PhD
  • Phone Number: 84902028181
  • Email: nvt@nihe.org.vn

Study Contact Backup

  • Name: Tuan A Le, MD, PhD
  • Phone Number: 84983738688
  • Email: lat@nihe.org.vn

Study Locations

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Murdoch Children Research Institute
  • Vietnam
      • Hai Phong, Vietnam, 180000
        • Center for Supporting Community Development Initiatives SCDI-Vietnam
        • Contact:
        • Contact:
      • Hai Phong, Vietnam, 180000
        • Hai Phong Center for Disease Control
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Kien T Dong, MD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

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?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / 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
Other Names:
  • Gardasil 9
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
Other Names:
  • Gardasil 9
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
Other Names:
  • Gardasil 9

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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).
7 months from the first doses

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
19 months after the 1st doses
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.
19 month after the first doses
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.
19 months after the 1st dose
HPV persistent during 19 month or more among vaccines
Time Frame: 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).
at least 19 months after the first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Hygiene and Epidemiology, Vietnam

Collaborators

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

Investigators

  • Study Director: Hong T Duong, MD, PhD, National Institute of Hygiene and Epidemiology, Vietnam
  • Principal Investigator: Trang V Nguyen, PhD, National Institute of Hygiene and Epidemiology, Vietnam
  • Principal Investigator: Tuan A Le, MD, PhD, National Institute of Hygiene and Epidemiology, Vietnam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 14, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 7, 2024

First Posted (Estimated)

November 8, 2024

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 7, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPV9-VINIF2427

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared. Results will be reported as grouped data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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