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.

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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. 

Condition

Healthy Pregnant Women

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Age

18 to 40 years

The age a person must be to participate in a clinical trial.

Sex

Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

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.

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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.

Length of study treatment

Up to 16 months

Length of study treatment is the length of time the study participants will receive the study treatment.

Number of study visits

Up to 9 study visits

Each clinical trial’s design specifies the number of study visits and the total length of the trial.

Long-term follow up

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.