BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
The BEATRIX study is investigating a new vaccine designed to protect against Group B Streptococcus (GBS). GBS is a common bacteria that many people carry without symptoms, but it can sometimes cause serious infections in newborns. This study wants to learn about the safety and effectiveness of this GBS vaccine in healthy pregnant women and their babies. Participants will receive a single shot, which could be the GBS vaccine or a saltwater placebo. Researchers will follow the women for several months after delivery and their babies for about a year to see how they respond and to monitor their health. A small group of babies will also have blood tests related to their routine childhood vaccines.
At a glance
What is this study about?
The BEATRIX study is a research project focused on a vaccine for Group B Streptococcus, often called GBS. GBS is a very common type of bacteria that can live harmlessly in the body. However, in some cases, it can cause serious infections, especially in newborn babies, which can be life-threatening. The main goal of this study is to find out if this new GBS vaccine is safe for pregnant women and their babies, and how well it helps protect them from GBS infections. By studying the vaccine, researchers hope to find a way to prevent these infections in the future.
This study is important because GBS infections in newborns can lead to serious health problems like blood infections, pneumonia, and meningitis. Developing a safe and effective vaccine for pregnant women could be a major step in preventing these issues and improving the health of babies. The study will carefully look at how the bodies of both the mothers and their babies respond to the vaccine, monitoring any changes in their health.
During the study, some participants will receive the actual GBS vaccine, while others will receive a 'placebo' – which is like a dummy injection containing only saltwater. This comparison helps researchers understand the true effects of the vaccine. All information collected will be kept confidential, and the study is designed with participant safety as the top priority.
Key takeaways
- Helps research a new vaccine for Group B Streptococcus (GBS) in pregnant women.
- Aims to find out if the vaccine is safe and how well it works.
- Participation involves a single injection (vaccine or placebo) and follow-up visits.
- You and your baby will be followed for up to 14 and 12 months respectively.
- Recruiting healthy pregnant women aged 49 or under, 24-36 weeks pregnant.
Who may be eligible?
The BEATRIX study is looking for healthy pregnant women who are 49 years old or younger. You need to be between 24 and 36 weeks pregnant when you get the study injection. It's important that your pregnancy is straightforward, and a recent scan should have shown no significant health problems with your baby.
Before joining, you’ll also need to have had recent negative tests for HIV, syphilis, and Hepatitis B during your current pregnancy. You won't be able to join if you have certain health conditions, like a very high BMI before pregnancy, complications in your current or past pregnancies that might make taking part risky, or a serious infection during this pregnancy, including a known GBS infection.
If you meet these criteria and decide to take part, you'll also need to agree for your baby to participate in the study after they are born. For babies, they need to be the child of a consenting mother and cannot be related to the research staff directly involved in the study.
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 24 and 36 weeks pregnant?
- Are you 49 years old or younger?
- Has your pregnancy been straightforward so far, with a normal scan?
- Do you have negative tests for HIV, syphilis, and Hepatitis B from this pregnancy?
- Do you agree for your baby to take part in follow-up appointments after birth?
What does participation involve?
If you decide to take part in the BEATRIX study, you'll receive a single injection in your arm. This will either be the GBS vaccine or a saltwater placebo. You won't know which one you receive, as this helps researchers get accurate results.
As a pregnant participant, you'll be involved for up to 14 months in total, which includes about 6 months after your baby is born. You'll need to visit the study clinic about 3 to 4 times, and some of these check-ups might be possible over the phone, which can be more convenient. Your baby will be part of the study for about 12 months after birth, for follow-up on their health.
A small number of babies in the study will also be asked to participate for a little longer, up to 19 months. This small group might have a blood sample taken after they've had their routine childhood vaccinations (like diphtheria and pneumonia shots) as part of their standard health care. This helps researchers understand how the GBS vaccine might interact with other childhood vaccines.
Potential risks and benefits
Locations (179)
- Center for Research in Women's HealthVerified postcodeBirmingham, United States· Recruiting
- Children's of AlabamaVerified postcodeBirmingham, United States· Recruiting
- University of Alabama at Birmingham - School of MedicineVerified postcodeBirmingham, United States· Recruiting
- University of Alabama at Birmingham Women & Infants CenterVerified postcodeBirmingham, United States· Recruiting
- SEC Clinical ResearchVerified postcodeDothan, United States· Recruiting
- ClinMedVerified postcodePhoenix, United States· Recruiting
- Valleywise Comprehensive Health Center Women's ClinicVerified postcodePhoenix, United States· Recruiting
- Valleywise Health Medical CenterVerified postcodePhoenix, United States· Recruiting
- Genesis OB/GYNVerified postcodeTucson, United States· Recruiting
- Eclipse Clinical ResearchVerified postcodeTucson, United States· Recruiting
- Antelope Valley Medical CenterVerified postcodeLancaster, United States· Recruiting
- Chemidox Clinical TrialsVerified postcodeLancaster, United States· Recruiting
Common questions
What is Group B Streptococcus (GBS)?
GBS is a common type of bacteria that many people carry without symptoms, but it can sometimes cause serious infections in newborn babies.
Will I know if I get the vaccine or the placebo?
No, to ensure fair results for the study, you won't know if you received the GBS vaccine or the saltwater placebo. This is called 'blinding'.
How many visits will I need to make?
You will need to visit the research site approximately 3 to 4 times, and some follow-up can be done over the phone.
How long will I and my baby be in the study?
You will be in the study for up to 14 months (6 months after delivery), and your baby for about 12 months, with a small group of babies followed for up to 19 months.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time, for any reason, and your medical care will not be affected.
How to find out more
Pfizer CT.gov Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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