Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

Safety and efficacy of GSK Neisseria gonorrhoeae GMMA (NgG) investigational vaccine when administered to healthy adults 18 to 50 years of age

This research is looking at a new vaccine designed to prevent gonorrhoea, a common sexually transmitted infection. It's an early-stage study, meaning it's one of the first times this vaccine is being given to people. The main goals are to find out if the vaccine is safe for healthy adults, aged 18 to 50, and if it can help their immune system create a protective response against the bacteria that causes gonorrhoea. Because there isn't a clear way yet to measure how well the body fights off gonorrhoea, this study will also help researchers understand if the vaccine is effective. Participants will be healthy men and women.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Glaxosmithkline Biologicals

Enrolment target

592

Start

03 May 2023

What is this study about?

This study is about a new vaccine that scientists hope will protect people from gonorrhoea. Gonorrhoea is a common infection that can be passed on during sex. It can cause problems if not treated, and because some types of gonorrhoea are becoming harder to treat with medicines, a vaccine could be a very important tool to prevent the infection in the first place.

This particular study is a 'first-in-human' trial, which means it's one of the very first times this specific vaccine is being given to people. The main purpose is to check two important things: first, if the vaccine is safe for people to take, and second, if it can make the immune system — your body's natural defence — get ready to fight off gonorrhoea.

Normally, when testing vaccines, scientists look for certain signals in the blood that show the vaccine is working. However, for gonorrhoea, it's not yet clear exactly what these signals should look like. So, this study will also help researchers understand more about how the body reacts to the vaccine and how they might measure its protective effects in the future.

Key takeaways

This study is testing a new vaccine against gonorrhoea.
It's an early-stage trial, focusing on safety and how the immune system reacts.
Healthy adults aged 18-50, both men and women, can participate.
Participation involves clinic visits, vaccine doses, blood tests, and health checks.
You will be closely monitored for any side effects.
Taking part is voluntary, and you can leave at any time.

Who may be eligible?

To be considered for this study, you need to be a healthy adult aged between 18 and 50 years old. Both men and women can take part. Being healthy means you generally don't have any major ongoing health conditions that could affect the study's results or your safety.

When you first speak to the study team, they will ask you some questions about your health and medical history. They will also do some tests to make sure that you meet all the specific requirements for joining the study. This helps ensure everyone taking part is suitable and safe.

The research team will review all your information carefully. If you don't meet these specific health criteria, don't worry, it simply means this particular study isn't the right fit for you.

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 50 years old?
Are you generally in good health?
Are you able to attend several clinic appointments?
Are you comfortable with blood tests?
Are you willing to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the study clinic several times over a period to receive the vaccine. You'll likely get a few doses of the vaccine over time, similar to how other vaccines are given. At each visit, the study team will check your health, ask how you're feeling, and take blood and other samples. These tests help them check the vaccine's safety and how your immune system is responding.

You'll be monitored closely after each vaccine dose for any side effects. There will also be follow-up visits after you've had all your vaccine doses to continue checking your health and blood samples. The total duration of your involvement, from the first vaccine to the final check-up, will be explained to you by the study team before you agree to take part.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as contributing to scientific understanding and potentially protecting yourself from gonorrhoea if the vaccine proves to be effective. However, as this is an early-stage vaccine, there might be unknown side effects, and it's not guaranteed that the vaccine will fully protect you. You might experience common vaccine side effects like soreness at the injection site, tiredness, or a mild fever. The study team will monitor you closely for any reactions. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Spain
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Unverified
France

Common questions

What is gonorrhoea?

Gonorrhoea is a common infection, usually caught during sex. It can cause discomfort and, if not treated, can lead to more serious health problems.

Is this vaccine already available?

No, this is an investigational vaccine, meaning it's still being tested and is not yet available to the public.

Will I definitely get the actual vaccine?

Some studies use 'placebos' (dummy treatments), but the study team will explain exactly what you would receive if you join.

Will I have to pay to take part?

No, you will not have to pay to participate in the study. All study-related care and medicines will be provided free of charge.

What if I get gonorrhoea during the study?

The study team will provide information on what to do if you suspect you have contracted an infection and will ensure you receive appropriate medical care.