Europas førende søgning efter kliniske forsøg

HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN ADJUVANTED BY AS04 ADSORBED ON ALUMINIUM HYDROXIDE, HYDRATED PRODUCED ON BACULOVIRUS HI-5 RIX4446 CELLS, TRICHOPLUSIA NI. DERIVED

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 HPV vaccination works in preventing infection. The trial data here focus on men who have sex with men, especially young adults, and measure HPV-16 and HPV-18 DNA positivity.

Table of contents

Trial overview

The trial titled Human papillomavirus vaccine effectiveness study among men who have sex with men is authorised and listed as a Phase 3 study.[1] It is an interventional study with a planned enrollment of 730 people.[1]

The study is about HPV infection and prevention of HPV infection among healthy participants.[1] The brief summary says the goal is to assess the direct effectiveness of vaccination with the bivalent HPV vaccine against anal HPV-16/18 infections among men who have sex with men aged 19 to 26 years who visit the Sexual Health Clinic in Amsterdam.[1]

Who is being studied

The target population is men who have sex with men (MSM), especially those aged 19 to 26 years.[1] The study compares vaccinated and unvaccinated MSM attending the sexual health center.[1]

This means the researchers are looking at real-world protection in a specific group that visits a sexual health clinic, rather than studying the vaccine in a general population.[1]

Study design and phase

The source describes the study as interventional, which means researchers are studying the effect of a vaccine-related intervention and comparing outcomes between groups.[1] The phase is listed as Phase 3, which usually means a later-stage study with a larger group of participants.[1]

The intervention named in the trial record is Cervarix suspension for injection, described as a human papillomavirus vaccine with types 16 and 18.[1] The trial record uses this product name, while the clinical trial article here focuses on the study itself rather than the vaccine details.[1]

What the study measures

The main outcome is a comparison of anal HPV-16/18 prevalence between vaccinated and unvaccinated MSM attending the sexual health center.[1] The primary measurement is HPV-16 and HPV-18 DNA positivity.[1]

In simple terms, the researchers want to know how often these HPV types are found in the study groups.[1] This helps show whether vaccination is linked to fewer infections in the group being studied.[1]

Key patient points

  • The study is focused on prevention of HPV infection in a specific group: MSM aged 19 to 26 years.[1]

  • It is a Phase 3 study, so it is in a later research stage and includes a relatively large planned group of participants.[1]

  • The main outcome is whether HPV-16 and HPV-18 are found in anal samples, measured as DNA positivity.[1]

  • The study compares vaccinated and unvaccinated people to see whether vaccination is linked to lower infection rates.[1]

Trial ID Phase Condition studied Status Enrollment
2022-502224-49-00 Phase 3 HPV infection; prevention of HPV infection among healthy participants Authorised 730

FAQ

  • Who can join the trial? The study focuses on men who have sex with men (MSM) aged 19 to 26 years who visit the Sexual Health Clinic in Amsterdam. It compares vaccinated and unvaccinated participants.
  • What is being studied? The trial looks at whether vaccination is linked to lower anal HPV-16/18 infection. The main measure is HPV-16 and HPV-18 DNA positivity.
  • What phase is the study? This trial is listed as Phase 3. That means it is a later-stage study that looks at how well the intervention works in a larger group.
  • What condition is the trial about? The study is about HPV infection and prevention of HPV infection among healthy participants. It is centered on anal HPV infection in MSM.
  • How many people are planned for the study? The planned enrollment is 730 participants. This gives the study a larger group to compare vaccinated and unvaccinated people.

Igangværende kliniske forsøg 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

  • Undersøgelse af HPV-vaccinen Cervarix til forebyggelse af HPV-infektion hos mænd mellem 19-26 år der har sex med mænd

    Rekrutterer

    1 1 1 1
    Undersøgte lægemidler:
    Holland

Ordliste

  • HPV: Short for human papillomavirus. It is the virus being studied in this trial.
  • HPV-16 and HPV-18: Two specific HPV types that the study measures in anal samples.
  • DNA positivity: A test result showing that HPV DNA was found. This means the virus was detected.
  • Anal HPV prevalence: How common HPV infection is in the anal area among the people in the study.
  • Men who have sex with men (MSM): A study population used in the trial. It refers to men who have sex with other men.
  • Sexual Health Clinic (SHC): The clinic where the study participants visit and where the comparison is made.
  • Phase 3: A later stage of clinical research that usually studies how well a treatment or prevention strategy works in a larger group.
  • Interventional study: A study in which researchers look at an intervention, such as a vaccine, and measure the results.
  • Vaccinated and unvaccinated: Two groups in the study. One group received the vaccine, and the other did not, so researchers can compare outcomes.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/undersogelse-af-hpv-vaccinen-cervarix-til-forebyggelse-af-hpv-infektion-hos-maend-mellem-19-26-ar-der-har-sex-med-maend/