AuthorisedPhase II and Phase III (Integrated)Interventional

A Randomised, Observer-Blind Trial to Evaluate the Immunogenicity, Safety, and Reactogenicity of a Group B Streptococcus Vaccine (GBS-NN/NN-2) when 1 Dose is Administered Concomitantly with the TDaP Vaccine in Healthy Non-pregnant Women 18 to 49 years of age Compared to when Each Vaccine is Administered Alone

This research is testing a new vaccine designed to protect against Group B Streptococcus (GBS) infection. Researchers want to find out how well this new vaccine works to create protection in the body, and how safe it is, in healthy women aged 18 to 49 who are not pregnant. The study compares giving the new GBS vaccine at the same time as a standard tetanus, diphtheria, and whooping cough (TDaP) vaccine, versus giving each vaccine separately. This helps determine if they can be given together without issues. The trial also looks for any side effects and how the body responds to each vaccine over time.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Minervax ApS

Enrolment target

564

Start

30 Oct 2024

Prevention of Group B streptococcus infection

What is this study about?

This study is all about finding a new way to prevent Group B Streptococcus (GBS) infections. GBS is a common type of bacteria that can sometimes cause serious health problems, especially in newborn babies. Currently, there isn't a widely available vaccine specifically for GBS. This research aims to change that by testing a new GBS vaccine.

Researchers are particularly interested in seeing if this new GBS vaccine can be given at the same time as the vaccine for tetanus, diphtheria, and whooping cough (often called TDaP). Giving two vaccines at once could be more convenient for people and help ensure more people get protected. The study will track how the body's immune system responds to these vaccines and carefully monitor for any side effects.

By understanding how effective and safe this new GBS vaccine is, both on its own and when given with the TDaP vaccine, doctors hope to get closer to offering better protection against GBS infections, particularly for pregnant women and newborns in the future. This is an important step towards improving public health.

Key takeaways

Tests a new vaccine to prevent Group B Strep infection.
Specifically for healthy, non-pregnant women aged 18 and over.
Compares giving GBS vaccine with a TDaP vaccine versus alone.
Measures how well the vaccines create protection and watches for side effects.
Aims to find a safe and effective way to protect against GBS.

Who may be eligible?

This study is looking for healthy women, aged 18 and older. You would not be able to join if you are currently pregnant.

While the lower age limit is 18, there is no upper age limit for participation, as long as you meet the other health criteria. The main goal is to test the vaccine in women who could potentially become pregnant in the future, as GBS is a particular concern for mothers and their babies.

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 woman?
Are you 18 years old or older?
Are you currently not pregnant?
Are you generally healthy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new Group B Strep vaccine, the existing tetanus, diphtheria, and whooping cough (TDaP) vaccine, a dummy (salt water) injection, or a combination of these. Your specific group would be decided by chance, like flipping a coin, and neither you nor the study team would know which treatment you are receiving (this is called being 'observer-blinded').

You would have several visits to the clinic over a period of time. These visits would involve having your blood taken to check how your body is responding to the vaccines. The team would also carefully ask you about any side effects you might experience, both in the days immediately after the vaccination, and over a longer period. The total duration of your involvement in the study, including all follow-up, would be determined by the study design, but generally, vaccine studies track participants for many months.

Potential risks and benefits

Taking part in a study like this might offer a chance to contribute to medical science, potentially helping to protect others from Group B Strep in the future. You would also receive the tetanus, diphtheria, and whooping cough vaccine if you are in certain groups. However, there are potential risks, including side effects from the vaccines, such as pain or swelling at the injection site, fever, or other reactions, which will be carefully monitored. You're free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

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Unverified
Belgium
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Unverified
Poland

Common questions

What is Group B Strep (GBS)?

GBS is a common bacteria that can live harmlessly in the body, but can sometimes cause serious infections, especially in newborn babies.

Why are researchers testing a new GBS vaccine?

Currently, there isn't a specific vaccine to prevent GBS infections that is widely available. This study aims to find a new way to protect people, particularly pregnant women and their babies.

What does 'concomitantly' mean?

'Concomitantly' means at the same time. The study is checking if the new GBS vaccine can be safely and effectively given at the same time as another routine vaccine.

What are 'antibodies' and why are they measured?

Antibodies are special proteins made by your body's immune system to fight off infections. Measuring them helps researchers see if the vaccine is successfully teaching your body to protect itself.

Will I know if I'm getting the new vaccine or a dummy shot?

No, this is an 'observer-blind' study, meaning neither you nor the study team will know which treatment you receive. This helps keep the results fair and unbiased.