Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)
This research is looking into a 9-valent Human Papillomavirus (HPV) vaccine for men aged 20 to 45. The main goal is to find out if this vaccine is good at stopping specific types of HPV infections in the mouth that last for a long time (six months or more). We're also checking how safe the vaccine is and how well the body reacts to it by creating protection. Some men will get the vaccine, while others will get a placebo (a harmless salt solution), so we can fairly compare the results. There's also a follow-up part for those who got the placebo to potentially receive the vaccine.
At a glance
What is this study about?
You might have heard about HPV, or Human Papillomavirus. It's a very common virus, and some types can cause health problems. This research study is looking at a specific vaccine designed to protect against nine types of HPV in men aged 20 to 45. The main idea is to see if this vaccine can prevent lasting HPV infections in the mouth. These are infections caused by certain HPV types that stick around for six months or longer.
To find this out, some participants will receive the active vaccine, while others will get a placebo, which is a harmless liquid that looks just like the vaccine but contains no active ingredients. This allows the researchers to fairly compare if the vaccine is truly effective or if any changes happen by chance. They will also be closely watching to make sure the vaccine is safe and to see how strong a protective response the body makes against HPV.
There's also a chance to continue in an 'Extension Study'. If you were in the group that received the placebo in the main study, or if you didn't finish all the vaccine doses, this extension offers you the opportunity to complete the full three doses of the HPV vaccine.
Key takeaways
- This study is testing an HPV vaccine in men aged 20-45.
- It aims to prevent long-lasting HPV infections in the mouth.
- Participants will receive either the vaccine or a dummy injection.
- The study checks for vaccine safety and how well it works.
- There's an option to receive the vaccine later if you got the dummy injection.
Who may be eligible?
To join this study, you need to be a healthy man between 20 and 45 years old. You must be able to understand the study information and be willing to give your permission to take part. It's also important that you can be contacted easily for follow-up appointments and have had at least one sexual partner in your lifetime.
However, there are reasons why you *wouldn't* be able to join. For example, if you've ever had certain HPV-related health problems like anal lesions or head and neck cancer, or if you have visible signs of HPV or other sexually transmitted infections. You also can't take part if you're allergic to any vaccine ingredients, have issues with blood clotting, or if your immune system isn't working properly.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a man between 20 and 45 years old?
- Are you generally healthy?
- Do you have at least one sexual partner in your lifetime?
- Can you understand study information and give your permission?
- Have you ever had specific HPV-related cancers or lesions?
What does participation involve?
If you join this study, you will receive either the HPV vaccine or a placebo (a dummy injection) over a series of three doses. The study team will check your health at the start and throughout. You'll have regular check-ups, and the researchers will collect samples, likely to check for HPV infection and how your body is responding to the vaccine. You'll also be asked to complete some reports yourself. The total duration of participation isn't specified but typically involves several visits over many months to a few years to track long-term effects.
Potential risks and benefits
Locations (103)
- Valley Clinical Trials Inc. ( Site 0002)Verified postcodeNorthridge, United States
- Inland Empire Clinical Trials, LLC ( Site 0025)Verified postcodeRialto, United States
- Alta California Medical Group ( Site 0031)Verified postcodeSimi Valley, United States
- Encompass Clinical Research ( Site 0028)Verified postcodeSpring Valley, United States
- Diablo Clinical Research, Inc ( Site 0042)Verified postcodeWalnut Creek, United States
- Clinical Research of South Florida ( Site 0036)Verified postcodeCoral Gables, United States
- Acevedo Clinical Research Associates ( Site 0001)Verified postcodeMiami, United States
- Moffitt Cancer Center ( Site 0017)Verified postcodeTampa, United States
- Augusta University ( Site 0010)Verified postcodeAugusta, United States
- Solaris Clinical Research, LLC ( Site 0003)Verified postcodeMeridian, United States
- Cotton-O'Neil Clinical Research Center ( Site 0044)Verified postcodeTopeka, United States
- Heartland Research Associates, LLC ( Site 0034)Verified postcodeWichita, United States
Common questions
What is HPV?
HPV, or Human Papillomavirus, is a very common virus. Some types can cause health issues, including certain cancers and warts.
What does a '9-valent' vaccine mean?
A '9-valent' vaccine means it's designed to protect against nine different types of the HPV virus, offering broader protection.
What is a placebo?
A placebo is a harmless substance, like a salt water injection, that looks exactly like the vaccine but contains no active ingredients. It helps researchers fairly compare results.
Will I know if I get the vaccine or the placebo?
In the main study, participants won't know if they received the vaccine or the placebo. This helps ensure fair results. However, there's an option to get the actual vaccine later if you received the placebo.
Is this vaccine used for protection against cancers?
While some HPV types can cause cancers, this study specifically focuses on preventing persistent HPV infections in the mouth. General HPV vaccination can help prevent certain HPV-related cancers.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.