RecruitingEARLY_PHASE1INTERVENTIONAL

PANHPVAX, Study of a New HPV Vaccine in Healthy Volunteers

This study is investigating a new vaccine called PANHPVAX for Human Papillomavirus (HPV). HPV can cause certain cancers, including those of the reproductive organs and mouth/throat. Currently available vaccines protect against some HPV types, but this new vaccine is designed to protect against a wider range of HPV types by targeting a different part of the virus. This is an early-stage trial, focusing on checking the safety and how well different doses (10µg, 40µg, 100µg) of PANHPVAX are tolerated in healthy volunteers. It will also look at whether the vaccine helps the body create protective responses. The main goal is to see if this new approach can eventually lead to a more comprehensive HPV vaccine.

At a glance

Status

Recruiting

Phase

EARLY_PHASE1

Sponsor

German Cancer Research Center

Enrolment target

Start

07 Nov 2022

Estimated completion

01 Dec 2027

HPV

What is this study about?

You might have heard of Human Papillomavirus, or HPV. It's a common virus that can cause several types of cancer, especially those affecting the reproductive organs, and also head and neck cancers. There are vaccines available now that protect against HPV, and these have been very successful in preventing many infections and cancers.

However, the current vaccines target a specific part of the HPV virus called L1, which means they only protect against the specific HPV types included in the vaccine. This new vaccine, PANHPVAX, works differently. It targets another part of the virus, called L2, which is more similar across many different types of HPV. This difference means that PANHPVAX could potentially offer protection against a much broader range of HPV types, including those that cause cancer and some that cause warts.

This study is an early step in developing PANHPVAX. It’s called a 'first-in-human' study because it's the first time this vaccine is being given to people. Researchers want to carefully check if the vaccine is safe and if people can tolerate it well at different doses. They also want to see if the body produces a good immune response against the virus after vaccination. We hope this research will lead to better ways to protect people from HPV-related diseases in the future.

Key takeaways

This study is testing a brand new HPV vaccine called PANHPVAX.
It aims to find out if the vaccine is safe and well-tolerated in healthy adults.
PANHPVAX works differently from current vaccines and may offer wider protection against HPV types.
Participants will receive the vaccine and have several check-ups and blood tests.
This is an early-stage study to gather important safety information.

Who may be eligible?

To join this study, you need to be a healthy volunteer between 18 and 45 years old. Both men and women can take part. You must be willing to give your written consent, meaning you understand the study and agree to participate. You also need to be able to follow all the study instructions.

If you are a woman who could become pregnant, or a man who could father a child, you must agree to use effective contraception during the study and for four weeks after each vaccination. Alternatively, women who cannot become pregnant (for example, due to menopause or having had a hysterectomy), or people who are completely abstinent from sex, can also join. You should not be planning to have children while in the study.

There are also some reasons you wouldn't be able to join. For example, if you have certain existing health conditions or have received certain medications recently that might affect your immune system, or if you've had severe allergic reactions to previous vaccines. You also can't have a commercial HPV vaccine during the study period. The medical team will check your overall health through an examination and blood tests to make sure it's safe for you to participate.

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 between 18 and 45 years old?
Are you generally healthy and don't have any major ongoing medical conditions?
Are you willing to use effective contraception if you are able to have children?
Have you *not* had another HPV vaccine recently or plan to get one during the study?
Are you willing to attend multiple clinic visits and have blood tests?
Do you understand what the study involves and agree to follow all instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the PANHPVAX vaccine as an injection into a muscle, likely in your arm. You will receive an initial dose, followed by two more booster injections. The exact timing and number of injections will be fully explained by the study team.

During the study, you will attend several visits to the clinic. At these visits, the study team will: perform physical examinations to check your general health; take blood samples to monitor your safety and see how your body is responding to the vaccine; and ask you about any side effects or how you are feeling. You will be assigned to receive one of three different doses of the vaccine: 10µg, 40µg, or 100µg.

The study will involve regular check-ups over a period to ensure your safety and to collect all necessary information. The exact total duration of your participation, including all follow-up visits, will be clearly outlined by the study doctors before you agree to join.

Potential risks and benefits

Taking part in a study like this means you're helping to advance medical science, potentially leading to new health protections for future generations. There is no direct personal benefit from receiving a study vaccine as its effectiveness is still being investigated. You might experience common vaccine side effects like soreness, redness, or swelling at the injection site, or possibly mild flu-like symptoms. More serious side effects are rare, but the study team will monitor you closely. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University Hospital Department of Clinical Pharmacology and Pharmacoepidemiology
Verified postcode
Heidelberg, Germany· Recruiting

Common questions

What is HPV and why is it important?

HPV is a very common virus that can cause certain types of cancer, like cervical cancer, and also mouth/throat cancers and genital warts. Protecting against it is important for long-term health.

How is this new vaccine different from current HPV vaccines?

Existing vaccines target one part of the virus (L1), protecting against specific HPV types. This new vaccine (PANHPVAX) targets a different part (L2), which is common to many HPV types, potentially offering broader protection.

What does 'first-in-human' mean?

It means this is the first time this specific vaccine is being given to people. Researchers carefully check its safety and how well people tolerate it before conducting larger studies.

Will I get 'real' vaccine or a dummy shot?

Everyone in this study will receive one of the different doses of the PANHPVAX vaccine. There is no dummy shot (placebo) arm in this specific trial.

What side effects should I expect?

Common side effects might be mild, like pain or redness where you got the shot, or perhaps feeling a bit unwell, similar to a cold or flu. The study team will explain all possibilities.

How to find out more

Markus Kratzmann, Dr.

markus.kratzmann@nct-heidelberg.de +49 (0)6221 56 32014 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.