HPV Vaccine Immunity in High-risk Women

Phase 4 Completed 63 enrolled Murdoch Childrens Research Institute London School of Hygiene and Tropical Medicine · collab National Institute of Hygiene and Epidemiology, Vietnam · collab

NaSingle-groupOpen-labelPrevention

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.

Timeline

Start: 2022-09-14
Primary completion: 2023-04-19
Completion: 2023-04-19

Publications

Background 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gardasil	Vaccine	0.5 ml	Intramuscular

HPV Vaccine Immunity in High-risk Women

Summary

Timeline

Publications

Drugs

Indications