NCT03765073
Despite preventive measures, group B strep infection continues to threaten the health of infants around the world. Your participation in a new research study could help us find a vaccine.
Group B strep (GBS) is a bacterium that causes a variety of infections, especially in pregnant women and infants. Although GBS infections may be relatively minor in adults, GBS can cause more serious illness in infants, including sepsis, meningitis, pneumonia, and death. This study is evaluating if an investigational GBS vaccine is safe, and if it can help produce antibodies in pregnant women and their infants which would help them fight the infection and prevention of GBS disease.
Who may participate
Participating in a clinical trial is an important and personal decision. Thank you for considering the Group B Strep clinical trial. Participation in this study will help communities around the world affected by group B strep and your participation could make a difference.
This study is enrolling women who:
- Are 18 to 40 years old
- Are generally healthy or have stable chronic conditions
- Are pregnant with an uncomplicated, single pregnancy between 24 weeks 0 days to 35 weeks and 6 days gestation
There will be other study requirements that the study team will discuss with you.
Each clinical study 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
Study participants will be randomly assigned to a group that will receive either the investigational GBS vaccine or a placebo. Mothers will be asked to attend nine visits to the study doctor, including screening, vaccination, and follow-up visits with your newborn up to one year after delivery. Infants will be required to attend 6 follow up visits or phone evaluations after delivery.
The study team will perform frequent tests and monitor you and your baby’s health for one year after you deliver.
Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the main part of the study. This long-term follow up is to collect additional information on the study drug over time.
About Group B Strep
About Group B Strep
Group B strep (GBS) is a bacterium that causes a variety of infections, especially in pregnant women and infants. Although GBS infections may be relatively minor in adults, GBS can cause more serious illness in infants, including sepsis, meningitis, pneumonia, and death.
Currently, there are no approved vaccines to prevent Group B Strep.
About Vaccines
About Vaccines
Vaccines have been a tried and true tool for preventing a variety of diseases for over 200 years. With your help, we can add Group B Strep vaccine to the list.
