In short
Clinical trials are studying HUMAN PAPILLOMAVIRUS TYPE 16 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 works in preventing HPV infection. The trial data here focus on safety and effectiveness questions in healthy men who have sex with men, especially those aged 19-26 years.
Key points
- Clinical trial data for HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN ADJUVANTED BY AS04 ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED PRODUCED ON BACULOVIRUS HI-5 RIX4446 CELLS, TRICHOPLUSIA NI. DERIVED focus on prevention of HPV infection. The listed study is a Phase 3 interventional trial in men who have sex with men aged 19-26 years. It is authorised and includes 730 participants. The main comparison is between vaccinated and unvaccinated men. The main endpoint is HPV-16 and HPV-18 DNA positivity, especially in anal samples.
Trial overview
The available trial is titled Human papillomavirus vaccine effectiveness study among men who have sex with men and is listed as Authorised. It studies HPV infection prevention and includes healthy participants, with a focus on men who have sex with men.
The intervention listed in the source is a bivalent HPV vaccine, also named Cervarix in the trial record. The study is designed to assess the direct effectiveness of vaccination against anal HPV-16/18 infections.
Who is being studied
The target group in this trial is men who have sex with men (MSM) aged 19 to 26 years who visit the Sexual Health Clinic in Amsterdam. The brief summary also describes the study as being in healthy people for prevention of HPV infection.
This is important because the study is not looking at a broad general population; it is focused on a specific group with a clear health question. In simple terms, the researchers want to know how well vaccination works in this group in real clinic settings.
Study design and phase
The trial is interventional, which means a vaccine is being used as part of the study. It is also listed as Phase 3, which usually means a later-stage study with a larger group of participants to better understand how well the intervention works.
The enrollment is 730, showing that this is a relatively large study compared with early research phases. The trial compares vaccinated and unvaccinated MSM, which helps researchers estimate the vaccine’s direct effect.
What is being measured
The primary outcome is HPV-16 and HPV-18 DNA positivity. DNA positivity means the virus was found in a test sample, so this outcome shows how often these HPV types are present in each group.
The study specifically compares anal HPV-16/18 prevalence between vaccinated and unvaccinated participants. Prevalence means how common the infection is at the time of testing.
- Primary focus: whether HPV-16 or HPV-18 DNA is found in anal samples.
- Comparison groups: vaccinated versus unvaccinated MSM.
- Setting: Sexual Health Clinic in Amsterdam.
What the trial means for patients
This trial is focused on a practical question: does vaccination lower the chance of finding HPV-16 or HPV-18 in the anal area among young MSM? The answer may help show how effective the vaccine is in the studied group.
Because the study is authorised and includes a defined age group and clinic setting, it gives a clear picture of how the research is being carried out. The available source data do not list additional endpoints, so the main measured result in the trial record is HPV-16/18 DNA positivity.