In short
Clinical trials are studying HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN ADJUVANTED BY AS04 ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED PRODUCED ON BACULOVIRUS HI-5 RIX4446 CELLS, TRICHOPLUSIA NI. DERIVED to see how well vaccination may help prevent HPV infection. The trial data focus on effectiveness and HPV-16/18 DNA positivity in men who have sex with men aged 19-26 years.
Key points
- One clinical trial is listed for HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN ADJUVANTED BY AS04 ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED PRODUCED ON BACULOVIRUS HI-5 RIX4446 CELLS, TRICHOPLUSIA NI. DERIVED. The study is a Phase 3 trial in men who have sex with men aged 19-26 years and is authorised. It looks at HPV infection prevention and compares vaccinated with unvaccinated participants. The main outcome is anal HPV-16/18 DNA positivity. The planned enrollment is 730 participants.
Trial overview
The trial data describe one authorised study of HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN ADJUVANTED BY AS04 ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED PRODUCED ON BACULOVIRUS HI-5 RIX4446 CELLS, TRICHOPLUSIA NI. DERIVED in the setting of HPV infection prevention1. The study is titled “Human papillomavirus vaccine effectiveness study among men who have sex with men” and is being done in Amsterdam1.
Who can participate
The target population is men who have sex with men (MSM) aged 19 to 26 years who visit the Sexual Health Clinic in Amsterdam1. The study compares vaccinated and unvaccinated participants, so both groups are part of the research question1.
What is being studied
This study is looking at the direct effectiveness of vaccination against anal HPV-16/18 infections1. In simple terms, the researchers want to know whether vaccination is linked to less HPV-16 and HPV-18 in the anal area1.
The brief summary says the trial is focused on the bivalent HPV vaccine, also called Cervarix, but the trial record in this dataset is specifically about the clinical question of prevention and effectiveness in this group1.
Trial phase and design
This is a Phase 3 trial1. Phase 3 studies usually involve larger groups and help show how well a strategy works in real-world or near real-world settings.
The study type is listed as interventional, but the primary outcome description says the researchers will conduct an observational comparison between vaccinated and unvaccinated MSM attending the sexual health center1. This means the study compares groups and measures results without the summary giving details of a new treatment assignment plan1.
Outcomes being measured
The main outcome is the prevalence of anal HPV-16/18 between vaccinated and unvaccinated MSM1. Prevalence means how many people in the study have the infection at the time it is measured.
The primary outcome also specifically measures HPV-16 and HPV-18 DNA positivity1. DNA positivity means the test found genetic material from the virus in the sample.
Trial summary
The study is authorised and plans to enroll 730 participants1. It focuses on HPV infection prevention among healthy participants, with special attention to anal HPV-16/18 infection in MSM aged 19-26 years1.
Overall, the trial is designed to help show whether vaccination is associated with lower HPV-16/18 DNA positivity in this target group1.