Table of contents
- Overview of the trial
- Who the study is for
- Study design and phase
- Main outcome measured
- Key trial facts
Overview of the trial
This clinical research study is titled Human papillomavirus vaccine effectiveness study among men who have sex with men[1].
It is an authorised, interventional, Phase 3 trial with 730 planned participants[1].
The study is looking at HPV infection and the prevention of HPV infection among healthy participants[1].
Who the study is for
The target population is men who have sex with men aged 19 to 26 years[1].
Participants are recruited from the Sexual Health Clinic in Amsterdam[1].
The brief summary says the study aims to assess the direct effectiveness of vaccination against anal HPV-16/18 infections in this group[1].
Study design and phase
The trial is described as interventional, which means researchers are giving an intervention and then measuring the results[1].
It is in Phase 3, which is a later stage of clinical research used to study how well an intervention works in a larger group of people[1].
The intervention listed in the trial data is the bivalent HPV vaccine Cervarix, described as a suspension for injection in a multidose container[1].
Main outcome measured
The primary outcome is a comparison of anal HPV-16/18 prevalence between vaccinated and unvaccinated men who have sex with men attending the sexual health center[1].
In simple terms, the researchers want to see how often HPV-16 and HPV-18 are found in anal samples in the two groups[1].
The main measurement is HPV-16 and HPV-18 DNA positivity, meaning whether the virus genetic material is detected in the sample[1].
Key trial facts
Status: Authorised[1].
Phase: Phase 3[1].
Population: Men who have sex with men aged 19 to 26 years[1].
Setting: Sexual Health Clinic in Amsterdam[1].
Enrollment: 730 participants planned[1].
Main endpoint: Anal HPV-16/18 DNA positivity and prevalence comparison between vaccinated and unvaccinated groups[1].
