Clinical trial · Interventional
HPV Vaccine Immunity in High-risk Women
Evaluation of HPV Vaccine Immunity in High-risk Women: a Pilot Study
NCT04590521CI-TRIAL-00073520completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gardasil®, Merck | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- A standard 3-dose schedule (0, 2 and 6 months) of licensed HPV vaccine (Gardasil®, Merck) will be administered to all participants intramuscularly.
- interventionNames
- Biological: Gardasil®, Merck
Primary outcomes (2)
- measure
- Neutralising antibody (NAb) levels to HPV16
- timeFrame
- 7 months
- description
- Geometric mean titres (GMT) of HPV- specific antibody responses to HPV16 at Month 7.
- measure
- Neutralising antibody (NAb) levels to HPV18
- timeFrame
- 7 months
- description
- Geometric mean titres (GMT) of HPV- specific antibody responses to HPV18 at Month 7.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 25 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDEinstein 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. PMID 19684472
- DERIVEDVan 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. PMID 41764658