Clinical trial NCT04590521: HPV Vaccine Immunity in High-risk Women
Official title: Evaluation of HPV Vaccine Immunity in High-risk Women: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HPV Infection
Keywords: HPV vaccine
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: National Institute of Hygiene and Epidemiology, Vietnam
First posted: 2020-10-19
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will be given Gardasil (Merck) HPV vaccine
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Neutralising antibody (NAb) levels to HPV16
timeFrame: 7 months
measure: Neutralising antibody (NAb) levels to HPV18
timeFrame: 7 months
Secondary outcomes:
measure: NAb titres to HPV16 and 18 at baseline
timeFrame: Baseline
measure: NAb titres to HPV16 and 18 following one dose of Gardasil
timeFrame: Month 2
measure: NAb titres to HPV16 and 18 following second dose of Gardasil
timeFrame: Month 3
measure: NAb titres to HPV 52 and 58 at baseline
timeFrame: Baseline
measure: NAb titres to HPV52 and 58 following one dose of Gardasil
timeFrame: Month 2
measure: NAb titres to HPV52 and 58 following second dose of Gardasil
timeFrame: Month 3
measure: NAb titres to HPV52 and 58 following third dose of Gardasil
timeFrame: Month 7
measure: HPV prevalence rates in FSW at baseline
timeFrame: Baseline
measure: HPV prevalence rates in FSW at 2 months
timeFrame: Month 2
measure: HPV prevalence rates in FSW at 7 months
timeFrame: Month 7
measure: NAb titres stratified by HPV prevalence at baseline
timeFrame: Baseline
measure: NAb titres stratified by HPV prevalence at Month 6
timeFrame: Month 7
Other outcomes:
Locations:
city: Hải Phòng
country: Vietnam
facility: Hai Phong District Health Centre
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Kim Mulholland, MBBS
role: STUDY_DIRECTOR
References:
citation: Einstein MH, Baron M, Levin MJ, Chatterjee A, Edwards RP, Zepp F, Carletti I, Dessy FJ, Trofa AF, Schuind A, Dubin G; HPV-010 Study Group. Comparison of the immunogenicity and safety of Cervarix and Gardasil human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18-45 years. Hum Vaccin. 2009 Oct;5(10):705-19. doi: 10.4161/hv.5.10.9518. Epub 2009 Oct 14.