HPV Vaccine Immunity in High-risk Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HPV Infection

Intervention / Treatment
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* Biological: Gardasil®, Merck


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects will be given Gardasil (Merck) HPV vaccine
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV vaccine