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HPV InfectionPhase 4NCT04590521

HPV Vaccine Immunity in High-risk Women

A Phase 4 study testing Gardasil®, Merck in people with HPV Infection, run by Murdoch Childrens Research Institute at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for
HPV Infection
What is being tested?
Gardasil®, Merck
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteVietnam
Study dates
14 Sep 2022to 19 Apr 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Vietnam1 site

  • Hai Phong District Health Centre

    Haiphong

Other trials in Vietnam

About this study

Official title: 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.

Read the 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
Being tested
Gardasil®, Merck
Keywords
HPV vaccine
Medical subject headings
Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gardasil®, MerckBiological

    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).

Study groups in NCT04590521
Study groupRoleWhat they receive
InterventionExperimentalA standard 3-dose schedule (0, 2 and 6 months) of licensed HPV vaccine (Gardasil®, Merck) will be administered to all participants intramuscularly.
Receives: Biological: Gardasil®, Merck

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neutralising antibody (NAb) levels to HPV16

    Geometric mean titres (GMT) of HPV- specific antibody responses to HPV16 at Month 7.

    Measured: 7 months

  2. Neutralising antibody (NAb) levels to HPV18

    Geometric mean titres (GMT) of HPV- specific antibody responses to HPV18 at Month 7.

    Measured: 7 months

Secondary outcomes (12)

  1. NAb titres to HPV16 and 18 at baseline

    GMTs of NAb responses to HPV16 and 18 prior to receiving HPV vaccine

    Measured: Baseline

  2. 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

    Measured: Month 2

  3. 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

    Measured: Month 3

  4. NAb titres to HPV 52 and 58 at baseline

    GMTs of NAb responses to HPV52 and 58 prior to receiving HPV vaccine

    Measured: Baseline

  5. 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

    Measured: Month 2

  6. 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

    Measured: Month 3

  7. 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

    Measured: Month 7

  8. HPV prevalence rates in FSW at baseline

    The presence of HPV DNA will be measured using PCR on cervical swabs collected at baseline

    Measured: Baseline

  9. 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

    Measured: Month 2

  10. 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

    Measured: Month 7

  11. 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

    Measured: Baseline

  12. 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.

    Measured: Month 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start14 Sep 2022
  3. Primary completion19 Apr 2023
  4. Study completion19 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
All subjects will be given Gardasil (Merck) HPV vaccine
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04590521
Sponsor's protocol ID
HREC 2019.225
Status last verified
Jan 2024
First submitted
2 Mar 2020
Last updated
1 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

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.

    PubMed 19684472

  • Van Trang N, Tuan LA, Mai CTN, Ly LTK, Lien THM, Chung NT, Huyen DTT, Uyen NTT, Thanh NTT, Nhung TTH, Quang C, Von Mollendorf C, Murray G, Garland SM, Bright K, Licciardi PV, Mulholland K, Toh ZQ. Immunogenicity of Human Papillomavirus Virus Vaccine in a High-risk and Understudied Group: Female Sex Workers. J Infect Dis. 2026 Aug 3;234(1):e60-e68. doi: 10.1093/infdis/jiag112.

    PubMed 41764658

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gardasil®, Merck in people with HPV Infection, run by Murdoch Childrens Research Institute at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neutralising antibody (NAb) levels to HPV16 (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04590521, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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