HPV Vaccine Immunity in High-risk Women

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

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.

Study Overview

• Status: Completed
• Conditions: HPV Infection
• Intervention / Treatment: Biological: Gardasil®, Merck

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 4

Contacts and Locations

Study Locations

• Vietnam
  • Hải Phòng, Vietnam
    • Hai Phong District Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutralising antibody (NAb) levels to HPV16	Geometric mean titres (GMT) of HPV- specific antibody responses to HPV16 at Month 7.	7 months
Neutralising antibody (NAb) levels to HPV18	Geometric mean titres (GMT) of HPV- specific antibody responses to HPV18 at Month 7.	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NAb titres to HPV16 and 18 at baseline	GMTs of NAb responses to HPV16 and 18 prior to receiving HPV vaccine	Baseline
NAb titres to HPV16 and 18 following one dose of Gardasil	GMTs of NAb responses to HPV16 and 18 one month following the first dose of Gardasil vaccine given at baseline	Month 2
NAb titres to HPV16 and 18 following second dose of Gardasil	GMTs of NAb responses to HPV16 and 18 one month following the second dose of Gardasil given at Month 2	Month 3
NAb titres to HPV 52 and 58 at baseline	GMTs of NAb responses to HPV52 and 58 prior to receiving HPV vaccine	Baseline
NAb titres to HPV52 and 58 following one dose of Gardasil	GMTs of NAb responses to HPV52 and 58 one month following the first dose of Gardasil vaccine given at baseline	Month 2
NAb titres to HPV52 and 58 following second dose of Gardasil	GMTs of NAb responses to HPV52 and 58 one month following the second dose of Gardasil vaccine given at Month 1	Month 3
NAb titres to HPV52 and 58 following third dose of Gardasil	GMTs of NAb responses to HPV52 and 58 one month following the third dose of Gardasil vaccine given at Month 6	Month 7
HPV prevalence rates in FSW at baseline	The presence of HPV DNA will be measured using PCR on cervical swabs collected at baseline	Baseline
HPV prevalence rates in FSW at 2 months	The presence of HPV DNA will be measured using PCR on cervical swabs collected at month 2	Month 2
HPV prevalence rates in FSW at 7 months	The presence of HPV DNA will be measured using PCR on cervical swabs collected at month 7	Month 7
NAb titres stratified by HPV prevalence at baseline	NAb titres to HPV16/18/52/58 at Month 1 stratified by HPV16/18/52/58 at baseline	Baseline
NAb titres stratified by HPV prevalence at Month 6	NAb titres to HPV16/18/52/58 at Month 7 stratified by HPV16/18/52/58 at Month 6.	Month 7

Collaborators and Investigators

• Sponsor: Murdoch Childrens Research Institute
• Collaborators: London School of Hygiene and Tropical Medicine; National Institute of Hygiene and Epidemiology, Vietnam
• Investigators: Study Director: Kim Mulholland, MBBS, Murdoch Children's Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Actual): April 19, 2023
• Study Completion (Actual): April 19, 2023

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: October 11, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: HPV vaccine
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Urogenital Diseases; Genital Diseases; Papillomavirus Infections
• Other Study ID Numbers: HREC 2019.225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data set and the following documents: Study Protocol, Statistical Analysis Plan, Informed Consent Form, Analytic Code may be requested, starting 6 months after publication
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: Data requests from individuals or research groups outside MCRI will be reviewed by MCRI and the Sponsor-Investigator in accordance with MCRI's Data Sharing and Access Procedure for the Release of Data from MCRI Sponsored Investigator-Initiated Clinical Trials (MCTC079)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

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