HPV Vaccine Immunity in High-risk Women

Murdoch Childrens Research Institute

Status and phase: Completed; Phase 4

Conditions: HPV Infection

Treatments: Biological: Gardasil®, Merck

Study type: Interventional

Funder types: Other

Identifiers

NCT04590521

HREC 2019.225

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Intervention

Experimental group

Description:

A standard 3-dose schedule (0, 2 and 6 months) of licensed HPV vaccine (Gardasil®, Merck) will be administered to all participants intramuscularly.

Treatment:

Biological: Gardasil®, Merck