NCT04590521

HPV Vaccine Immunity in High-risk Women

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• HPV Infection

Interventions

Type	Name	Description
BIOLOGICAL	Gardasil®, Merck	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).

Timeline

• Start date: 2022-09-14
• Primary completion: 2023-04-19
• Completion: 2023-04-19
• First posted: 2020-10-19
• Last updated: 2024-02-01

Locations

1 site across 1 country: Vietnam