General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT07160244

Background Information

 The purpose of this study is to evaluate the safety and immunogenicity (ability to make antibodies, which protect against infection) of an investigational vaccine called group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6 for short). "Investigational" means that GBS6 has not been approved for use by the United States Food and Drug Administration. The bacteria group B streptococcus is typically found in the lower intestinal and vaginal tract of 1 out of 5 pregnant women. The group B streptococcus bacteria (GBS) can cause serious disease in young infants (in the first few months of life) and also in pregnant women. GBS6 is designed to help protect pregnant women and their babies from serious disease caused by the 6 most common types of GBS.

Pregnant women may carry group B streptococcus bacteria (GBS) in the lower intestinal and vaginal tract, which could cause illnesses such as urinary tract infections, chorioamnionitis (inflammation of the fetal membranes inside the uterus), puerperal infection (postpartum endometritis, an infection of the uterus and the surrounding area after giving birth) and puerperal sepsis (an infection spread through the bloodstream, which may be fatal). Serious infections in the pregnant women can lead to stillbirth (fetal death in the womb), preterm (premature) delivery and low birth weight. In newborns and young infants (first few months of life), GBS can cause invasive disease including sepsis (bacterial bloodstream infection), meningitis (inflammation of the membranes surrounding the brain) and pneumonia (lung infection), leading to death or serious health problems. Use of antibiotics during labor in pregnant women who are GBS carriers is effective for preventing GBS diseases in newborns within 7 days of life, when GBS testing and preventive treatments are available as part of the regular medical care.  However, research has shown that the preventive use of antibiotics during labor in pregnant women is not effective in preventing GBS disease in infants beyond 7 days of age.  

Pfizer is developing a new vaccine, group B streptococcus 6-valent polysaccharide conjugate vaccine ("GBS6" for short), to help protect pregnant women and their babies from invasive disease caused by the 6 most common types of GBS bacteria (known as "serotypes"). It is hoped that the GBS6 vaccine will cause a strong immune response in pregnant women. The antibodies that are made by the immune response could help fight off GBS for herself, and for the baby by passing her antibodies through the placenta. 

The purpose of this study is to gather safety information, meaning the type and frequency of any possible side effects in pregnant women and their infants when the GBS6 is given. This study will also assess the ability of GBS6 to stimulate an immune response by measuring the antibodies against the 6 most common serotypes of GBS.

For more information, please visit: https://clinicaltrials.gov/study/NCT07160244

Learn more about the study on the Pfizer website: https://www.pfizerclinicaltrials.com/find-a-trial/nct07160244-healthy-trial

Learn more about the development of the vaccine: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-new-england-journal-medicine-publication

Offered At

Inova Fairfax Medical Campus
3300 Gallows Road 
Falls Church, VA 22042
Principal Investigator

Antonio Saad, MD, MBA

Eligibility Information

  • Healthy pregnant women 18-49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and who have no known increased risk of complications.
  • Had a fetal anomaly ultrasound examination with no significant fetal abnormalities observed.
  • Documented negative human immunodeficiency virus (HIV) antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization.
  • Capable of giving personal signed informed consent.
  • Willing to give informed consent for her infant to participate in the study.

Ineligibility Information

  • Prepregnancy body mass index (BMI) of >40 kg/m2.
  • Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study.
  • Prior pregnancy complications or abnormalities that, based on the investigator's judgment, may increase the risk associated with the participation in and completion of the study.
  • History of microbiologically proven invasive disease caused by GBS in the current pregnancy.
  • A known or suspected infection during the current pregnancy that may increase the risk of complications in pregnancy (eg, active tuberculosis, syphilis, primary genital herpes simplex, malaria).