Group B Strep Clinical Trial

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 effective when administered alongside Tdap (tetanus, diptheria, pertussis) in healthy, nonpregnant women.

Card Summary Component

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 49 years old
Are generally healthy or have stable chronic conditions
Are not pregnant and are not breastfeeding
Have not received the Tdap vaccination in the last 5 years

There will be other study requirements that the study team will discuss with you.

Condition

Healthy and nonpregnant

Age

18 to 49 years

Sex

Female

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 one of three groups and will either receive:

The investigational GBS vaccine and the Tdap vaccine, or
The investigational GBS vaccine and a placebo, or
A placebo and the Tdap vaccine.

Participants will be asked to attend two (2) visits with the study doctor, including the screening and vaccination visit followed by the 1-month follow-up visit. You will be expected to keep an
e-diary for the first 7 days from your vaccination.

Length of study participation

Approximately 1 month

Number of study visits

2 study visits

Daily e-diary

You will be asked to complete your e-diary for 7 days from vaccination.

About Group B Strep

Currently, there are no approved vaccines to prevent Group B Strep.

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.