A Phase 1/2, Randomized, Placebo-Controlled, Observer-Blinded Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Multivalent Group B Streptococcus Vaccine in Healthy Nonpregnant Women and Pregnant Women 18 to 40 Years of Age and their Infants
Closed to recruitment, in follow up
Aim of the study
The purpose of this study is to evaluate the safety of a new investigational vaccine, group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6 for short, the study vaccine). The vaccine is designed to prevent infections caused by a germ (bacteria) called group B streptococcus (GBS) that can live in the body of healthy people and cause serious disease in people of all ages.
This germ may cause serious disease, including sepsis (infections of the blood), meningitis (infections of the lining covering the brain and spinal cord), and pneumonia (lung infection); less common disease includes skin and soft tissue, bone, and joint infections. In pregnant women, GBS may be associated with infections ranging from relatively simple urinary tract infections to infections of the womb (which may result in severe infection of the reproductive tract as well as severe birth complications). In infants, GBS may cause serious disease, including sepsis (infections of the blood), meningitis (infections of the lining covering the brain and spinal cord), and pneumonia (lung infection); less common disease includes skin and soft tissue, bone and joint infections. GBS is the most common cause of serious bacterial infections and meningitis in babies in the United Kingdom.
The first study in healthy non-pregnant adults was conducted in the United States and has shown that this vaccine was well tolerated. Stage 2 of this study was the first time the investigational vaccine was administered to pregnant women.
This study is being done to see what side effects occur after the study vaccine is injected and measure how your body responds to the study vaccine. We will also be collecting swab samples to find out what percentage of healthy pregnant women carry GBS bacteria.
The study is also being done to see if any antibodies are transferred from you to your child after he/she is born. We will also be collecting swab samples from your child (mouth and rectal area) to find out how many children born from vaccinated mothers carry GBS bacteria.
- Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study
- Willing and able to comply with scheduled visits, investigational plan, lab tests, and other study procedures, including completion of the e-diary from Day 1 to Day 7 following administration of IP
- Heathy female >=18 and <=40 years of age; between 27 0/7 (stage 2) or 24 0/7 (stage 3) and 35 6/7 weeks gestation on planned day of vaccination (uncomplicated, single, no increased complications, no fetal abnormality on ultrasound)
- Pregnant subjects must be receiving prenatal standard of care at the clinics/physician offices/hospital networks affiliated with clinical study site
- Determined by medical history, physical examination, screening laboratory assessment, and clinical judgement to be appropriate for inclusion in study
- Expected to be available for the duration of the study, can be contacted by telephone during study and expected to give informed consent for their infant subject to participate in the study
- Documented negative HIV antibody, HBV surface antigen, HCV antibody, and syphilis tests at screening
- Investigator site staff members involved in the conduct of the study/their family members/site staff members/subjects who are Pfizer employees, including their family, directly involved in the study
- Whose unborn baby has been fathered by Investigator site staff members involved in the conduct of the study/their family members/site staff members/subjects who are Pfizer employees, including their family
- For stage 2 sentinel-cohort subjects only, laboratory test results at the screening visit outside the normal reference range for pregnant women according to their trimester in pregnancy
- Participation in other studies involving investigational drug(s), vaccines, or medical devices within 28 days prior to study entry and/or during study participation
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the IP or any diphtheria toxoid-containing or CRM197-containing vaccine
- History of microbiologically proven invasive disease caused by GBS (S agalactiae), or history of an infant with GBS disease
- Current alcohol abuse or illicit drug use
- Body mass index (BMI) of >= 40 kg/m2 at the time of screening visit
- Clinical history of primary genital herpes simplex virus (HSV) infection during the current pregnancy
- Subjects with known or suspected immunodeficiency
- Subjects who receive treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids, or planned receipt through the 1-month postvaccination blood draw
- Other acute or chronic medical or psychiatric condition including recent or active suicidal ideation or behaviour, or laboratory abnormality that would make the subject inappropriate for the study
- Bleeding diathesis or condition associated with prolonged bleeding that would in the opinion of the investigator contraindicate intramuscular injection
- Previous vaccination with any licensed or investigational GBS vaccine, or planned receipt during subject’s participation in the study (through the last blood draw)
- Vaccination with diphtheria -or CRM197-containing vaccine(s) from 6 months before investigational product administration
- Receipt or planned receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration (with 1 exception, anti-D immunoglobulin (e.g. RhoGAM), which can be given at any time)
- Prior history of or current pregnancy complications or abnormalities that will increase risk associated with participation/ completion of study (refer to protocol and SRM for full details)
- Major illness of mother or conditions of foetus that will substantially increase risk associated with participation/completion of study or could preclude the evaluation of subject’s response
- Any known or suspected autoimmune or neuroinflammatory disease
What does participation in this study involve?
If you decide to participate, you will need to visit the study doctor 7 times to undergo study procedures and to provide information about your health. Once your child has been born, they will also attend study visits (4 visits to the study doctor) to undergo study procedures. You will also speak to the study doctor 2 times to inform them about you and your child’s health.
If you decide to participate, your/your child’s GP (general practitioner) will also be notified of your participation in this study.
You will be in this study for up to 16 months.
A list of the procedures that will be completed during the study (including screening) for you and/or your child when he/she is born are included in the Participant Information Sheet.