Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants
Group B Streptococcus Infections
About this trial
This is an interventional prevention trial for Group B Streptococcus Infections
Eligibility Criteria
Inclusion Criteria Stage 1 Nonpregnant Women:
- Healthy nonpregnant females 18 to 40 years of age at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
- Negative urine pregnancy test at Visit 1 (prior to vaccination).
- Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening.
Inclusion Criteria Stage 1 Booster Vaccination:
- Participant must have received investigational product at Visit 1.
- Healthy nonpregnant female determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for booster vaccination and received investigational product at Visit 1.
- Negative urine pregnancy test at Visit 6 (prior to vaccination).
- Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening.
Inclusion Criteria Stage 2 and 3 Maternal Participants:
- Healthy females >=18 and <=40 years of age who are >=27 0/7 (Stage 2) or >=24 0/7 (Stage 3) to <=35 6/7 weeks' gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and at no increased risk for complications and no significant fetal abnormalities observed on ultrasound performed at any time prior to study entry and/or at the screening visit.
- Documented negative HIV antibody, HBV surface antigen, HCV antibody, and syphilis tests at screening.
Inclusion Criteria Stage 2 and 3 Infant Participants:
Evidence of a signed and dated ICD signed by the parent(s). Parent(s) willing and able to comply with scheduled visits, investigational plan, laboratory tests, and other study procedures.
Exclusion Criteria Stage 1 Nonpregnant Women:
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine.
- History of microbiologically proven invasive disease caused by GBS (S agalactiae).
- Previous vaccination with any licensed or investigational GBS vaccine (other than GBS6 received as a primary vaccination at Visit 1), or planned receipt during the participant's participation in the study (through the last blood draw).
Exclusion criteria Stage 2 and 3 Maternal Participants:
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine.
- History of microbiologically proven invasive disease caused by GBS (S agalactiae).
- Previous vaccination with any licensed or investigational group B streptococcus vaccine, or planned receipt during the participant's participation in the study (through the last blood draw).
- Body mass index (BMI) of >=40 kg/m2 at the time of the screening visit.
- A prior history of or current pregnancy complications or abnormalities that will increase the risk associated with the participant's participation.
- Major illness of the mother or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in, and completion of, the study or could preclude the evaluation of the participant's response.
Exclusion criteria Stage 2 and 3 Infant Participants:
Infant who is a direct descendant (eg, child or grandchild) of the study personnel.
Sites / Locations
- MedPharmics, LLC
- MedPharmics, LLC
- Chemidox Clinical Trials Inc.
- Chemidox Clinical Trials Inc
- Emerson Clinical Research Institute
- Clinical Research Prime
- Clinical Research Prime Rexburg
- Lakeview Regional Medical Center
- MedPharmics
- St. Tammany Parish Hospital
- Velocity Clinical Research, Covington
- North Oaks Medical Center
- North Oaks Obstetrics & Gynecology
- MedPharmics, LLC (Recruitment Call Center)
- MedPharmics, LLC
- MedPharmics, LLC
- Velocity Clinical Research, Slidell
- Boeson Research
- Community Hospital
- The Birth Center
- Meridian Clinical Research
- Frontier Pediatric Care (Follow-Up Visits for Infant Participants)
- Bryan Women's Care Physicians (Maternal Visits & Obstetric Exams)
- Be Well Clinical Studies
- Meridian Clinical Research, LLC
- MedPharmics, LLC
- Velocity Clinical Research
- Lowcountry Women's Specialists
- Summerville Medical Center
- Coastal Pediatric Research
- St. Davids Medical Center
- Tekton Research, Inc
- Sentara Leigh Hospital
- The Group for Women
- Tidewater Physicians for Women
- Wits Reproductive Health and HIV Institute
- Respiratory and Meningeal Pathogens Research Unit (RMPRU)
- Empilweni Services and Research Unit (ESRU)
- Charlotte Maxeke Johannesburg Academic Hospital
- Khayelitsha Hospital
- Michael Mapongwana Community Health Centre
- FAMCRU
- St George's University Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Stage 1 - Highest dose formulation a
Stage 1 - Highest dose formulation b
Stage 2 - Lowest dose formulation a
Stage 2 - Lowest dose formulation b
Stage 2 - Middle dose formulation a
Stage 2 - Middle dose formulation b
Stage 2 - Highest dose formulation a
Stage 2 - Highest dose formulation b
Stage 3 - Selected dose and formulation
Stage 1 Placebo
Stage 2 Placebo
Stage 3 Placebo
Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Multivalent group B streptococcus vaccine - Stage 3 Pregnant women
Saline control
Saline control
Saline control