A Maternal Vaccine Study for Group B Strep
You may be eligible* to participate if you:
- are a healthy 18-40 years old female between ≥24 0/7 to ≤35 6/7 weeks gestation on the day of planned vaccination
- are having an uncomplicated, singleton pregnancy (one fetus), at no increased risk for complications, and show no significant fetal abnormalities observed on ultrasound performed at any time prior to study entry and/or at the screening visit.
*additional criteria apply
Speaking in general, vaccines are a part of a healthy pregnancy. When you get vaccinated during pregnancy, you are not only protecting yourself against dangerous, potentially deadly diseases, you are also protecting your baby.
Screening for GBS and intrapartum antibiotic prophylaxis in pregnant women has decreased the rate of GBS in newborns less than 1 week old, but these measures have not had any impact on reducing disease on women and infants older than 1 week.
The investigational vaccine in this study is designed to target the 6 types of GBS that cause the majority of infections in infants. The study vaccine was previously evaluated in nonpregnant women to confirm that is was safe, tolerable, and if it generated an immune response against GBS. The study is now being evaluated in healthy pregnany women.
When a pregnant person gets vaccinated, their body creates protective antibodies (immunity against diseases) and passes some of these antibodies to their baby that will last until their little one is ready to start getting their own vaccines.
For more information or to get started, please complete the confidential inquiry below:
According to the March of Dimes website:
Group B streptococcus (also called Group B strep or GBS) is a common type of bacteria (tiny organisms that live in and around your body) that can cause infection. Usually GBS is not serious for adults, but it can hurt newborns causing sepsis, meningitis, pneumonia and death.
While GBS may not be harmful to you, it can be very harmful to your baby. If you’re pregnant, you can pass it to your baby during labor and childbirth.
About 1 out of 4 pregnant women (25 percent) carry GBS bacteria. The best way to know if you have GBS is to get tested. If you do have GBS, though, there’s good news: your health care provider can give you treatment during labor and birth that protects your baby from GBS.
If your baby gets GBS, do signs of infection or other problems show up right after birth?
Not always. It depends on the kind of GBS infection your baby has. There are two kinds of GBS infections:
- Early-onset GBS: Signs like fever, trouble breathing and drowsiness start during the first 7 days of life, usually on the first day. Early-onset GBS can cause pneumonia, sepsis or meningitis. If you have GBS, you can pass this kind of infection to your baby. But treatment with antibiotics during labor and birth can help prevent your baby from getting it. About half of all GBS infections in newborns are early-onset.
- Late-onset GBS: Signs like coughing or congestion, trouble eating, fever, drowsiness or seizures usually start when your baby is between 7 days and 3 months old. Late-onset GBS can cause sepsis or meningitis. If you have GBS, you can pass this kind of infection to your baby during or after birth. Treatment with antibiotics during labor and birth does not prevent late-onset GBS. After birth, your baby also can get GBS from other people who have the infection.
What problems can GBS cause in newborns?
Babies with a GBS infection can have one or more of these illnesses:
- Meningitis, an infection of the fluid and lining around the brain
- Pneumonia, a lung infection
- Sepsis, a blood infection
Pneumonia and sepsis in newborns can be life-threatening.
To find out more general information on Group B Strep infections, click here