Group B strep (GBS) is a leading cause of serious bacterial infection in newborns, with over 300,000 cases each year.1
At birth, your baby’s immune system is not quite ready to fight infections on its own. That’s why we’re researching an investigational maternal vaccine that is designed to protect pregnant women and their babies from the 6 most common types of GBS.
Who may participate
The BEATRIX study is enrolling pregnant women who are:
- 49 years of age or younger
- Expecting a single healthy baby
- Able to be vaccinated during weeks 24-36 of your pregnancy
These are not the only qualifications needed to be in this study. Our study team will give you all the details to help you decide if the study is right for you and your baby.
Every medical breakthrough begins with a first step. By taking part in this study, you and your little one could positively impact the health of babies around the world.
Condition
Group B Strep (GBS)
Age
49 years of age or younger
Weeks of Pregnancy
Between 24 and 36 weeks pregnant
Each clinical trial has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If you join this study, you will receive 1 dose of the study vaccine or placebo between weeks 24 and 36 of your pregnancy. A placebo looks like the study vaccine but has no active ingredients.
You will be in the study until about 6 months after your baby is born and will have at least 5-6 study visits. Your baby will be in the study until they are 12 months old and will have at least 4 study visits. Some of your visits and your baby’s visits may happen at the same time, and a few of the visits will occur by phone.
You may also be invited to enroll your baby in an optional phase of the study where they would receive other childhood vaccines and have additional study visits.
Your health and the health of your baby are always our top priority. Both of you will be closely monitored by the study team and will receive multiple check-ups during the study. The study team will explain the procedures that will happen at each of these visits, so you know what to expect.
Number of vaccine doses
One dose
Visit schedule
At least 7-10 study visits over about 14 months
Watch a short video to learn more about the BEATRIX study
This video explains what will happen during the BEATRIX study to help you decide if joining is right for you and your baby.
About the study vaccine
At birth, your baby’s immune system is not quite ready to fight infections on its own. A maternal GBS vaccine may offer the protection your little one needs to stay healthy.
The investigational GBS vaccine has been given to more than 300 pregnant women and has been found to be safe and well tolerated. It is designed to activate the immune system, so it creates antibodies that fight against GBS. Some of these disease-fighting antibodies may be passed on to the developing baby through the placenta.
Maternal vaccines have been given safely to millions of pregnant women for over 50 years. Watch this short video to learn more about maternal vaccines and how they can help protect your baby.
Frequently asked questions
Group B strep (GBS) is a common type of bacteria that is found in about 1 in 5 pregnant women, which can cause complications during pregnancy and serious illness in babies. GBS can be passed to babies in the womb, at birth, and after.
Babies are vulnerable to GBS infection because their immune systems are still developing. GBS infection can lead to fever, trouble eating, and difficulty breathing. In serious cases it can become life threatening. Babies can develop pneumonia (infection of the lungs), sepsis (infection of the blood), and meningitis (infection of the brain and spinal cord). Even with treatment, some children develop long-term health problems from GBS including seizures, hearing loss, and vision loss. GBS can also cause serious complications for pregnant women, including premature delivery and stillbirth.
If you participate in the study, you will be assigned by chance (like pulling a number out of a hat) to receive either the study vaccine or placebo. Half of participants will receive the study vaccine and half will receive placebo.
As with any vaccine, local reactions at the injection site can be common – such as redness, swelling, or pain. There is also potential for other symptoms like a fever. The known side effects will be further explained in the informed consent document and discussed with you by the study doctor before you consider joining the study. If there is any new information that we learn about the study vaccine during the clinical trial, the study doctor will share that with you as well.
The decision to join a clinical trial is completely voluntary. You and your baby can leave the study at any time if you decide that you no longer want to take part.
References
1. Furuta A, Brokaw A, Manuel G, et al. Bacterial and host determinants of Group B streptococcal infection of the neonate and infant. Front Microbiol. 2022;13:820365. doi:10.3389/ fmicb.2022.820365
