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NCT Number: NCT04590521

HPV Vaccine Immunity in High-risk Women

This is a single arm immunological study based in Vietnam. The study will examine human papillomavirus (HPV) vaccine responses in high-risk women (female-sex-worker; FSW). We aim to recruit 60 women (aged 18-25 years old) and provide them with a standard 3-dose schedule of licensed 4vHPV vaccine (Gardasil®, Merck). Blood and cervical swab samples will be collected for immunology and virology testing, respectively.

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Key information

Conditions

HPV Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hai Phong District Health Centre

Haiphong, Vietnam

About this study

Multiple sexual partners (>4) is a risk factor for human papillomavirus (HPV) infection and cervical cancer. Due to the nature of their work, female sex workers (FSW) are at a particular high risk of HPV infection and developing cervical cancer. These groups are also likely to be reservoirs for HPV transmission since they are less likely to clear the infection and are known to be infected with multiple HPV types simultaneously. Benefits in vaccinating HPV-infected individuals, includes protecting them against HPV vaccine types that the person is not currently infected with as well as re-infection with the same HPV type. Therefore, immunising FSW with HPV vaccine is a novel strategy to reduce their risk of cervical cancer as well as downstream effects on HPV transmission. FSW is common in low-and middle-income countries (LMICs) of Asia (i.e. Vietnam), but the use of HPV vaccine in LMICs is very low often due to high costs and logistical difficulties in vaccine delivery. Furthermore, available data on the immunogenicity of HPV vaccine in FSW are limited. The aim of this study is to determine the immunogenicity of HPV vaccine in FSW and compare their antibody responses among young women (non-FSW) of the same age group by comparison with published data.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Each participant must meet all of the following criteria to be enrolled in this trial:
  • Is between the reporting ages of 18-25 years at the time of recruitment
  • Engage in commercial sex in the last month

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

Treatment and study plan

Gardasil®, Merck

Biological

Gardasil® (4vHPV) is a recombinant protein particulate (VLP) vaccine. Each 0.5 mL monodose pre-filled syringe or vial contains approximately 20 μg of HPV 6 L1 protein, 40 μg of HPV 11 L1 protein, 40 μg of HPV 16 L1 protein, and 20 μg of HPV 18 L1 protein as well as approximately 225 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant). It has completed phase III trials and is licensed for use in over 100 countries around the world including the United States, Australia and countries in the European Union (EU) for girls aged 9-26 years. Vietnam currently offer this vaccine in private health clinics, as a 3-dose schedule (0, 2 and 6 months).

Primary outcomes

  1. Neutralising antibody (NAb) levels to HPV16

    Time frame: 7 months

    Geometric mean titres (GMT) of HPV- specific antibody responses to HPV16 at Month 7.

  2. Neutralising antibody (NAb) levels to HPV18

    Time frame: 7 months

    Geometric mean titres (GMT) of HPV- specific antibody responses to HPV18 at Month 7.

Secondary outcomes

  1. NAb titres to HPV16 and 18 at baseline

    Time frame: Baseline

    GMTs of NAb responses to HPV16 and 18 prior to receiving HPV vaccine

  2. NAb titres to HPV16 and 18 following one dose of Gardasil

    Time frame: Month 2

    GMTs of NAb responses to HPV16 and 18 one month following the first dose of Gardasil vaccine given at baseline

  3. NAb titres to HPV16 and 18 following second dose of Gardasil

    Time frame: Month 3

    GMTs of NAb responses to HPV16 and 18 one month following the second dose of Gardasil given at Month 2

  4. NAb titres to HPV 52 and 58 at baseline

    Time frame: Baseline

    GMTs of NAb responses to HPV52 and 58 prior to receiving HPV vaccine

  5. NAb titres to HPV52 and 58 following one dose of Gardasil

    Time frame: Month 2

    GMTs of NAb responses to HPV52 and 58 one month following the first dose of Gardasil vaccine given at baseline

  6. NAb titres to HPV52 and 58 following second dose of Gardasil

    Time frame: Month 3

    GMTs of NAb responses to HPV52 and 58 one month following the second dose of Gardasil vaccine given at Month 1

  7. NAb titres to HPV52 and 58 following third dose of Gardasil

    Time frame: Month 7

    GMTs of NAb responses to HPV52 and 58 one month following the third dose of Gardasil vaccine given at Month 6

  8. HPV prevalence rates in FSW at baseline

    Time frame: Baseline

    The presence of HPV DNA will be measured using PCR on cervical swabs collected at baseline

  9. HPV prevalence rates in FSW at 2 months

    Time frame: Month 2

    The presence of HPV DNA will be measured using PCR on cervical swabs collected at month 2

  10. HPV prevalence rates in FSW at 7 months

    Time frame: Month 7

    The presence of HPV DNA will be measured using PCR on cervical swabs collected at month 7

  11. NAb titres stratified by HPV prevalence at baseline

    Time frame: Baseline

    NAb titres to HPV16/18/52/58 at Month 1 stratified by HPV16/18/52/58 at baseline

  12. NAb titres stratified by HPV prevalence at Month 6

    Time frame: Month 7

    NAb titres to HPV16/18/52/58 at Month 7 stratified by HPV16/18/52/58 at Month 6.

Sponsors and collaborators

Lead sponsor

Murdoch Childrens Research Institute

Other

Collaborators

  • London School of Hygiene and Tropical Medicine
  • National Institute of Hygiene and Epidemiology, Vietnam

Registry information

Official study title

Evaluation of HPV Vaccine Immunity in High-risk Women: a Pilot Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2020
Registry last updated
Feb 1, 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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