GBS6 Group B Streptococcus Description
GBS6 is a multivalent group B streptococcus vaccine candidate
GBS6 Group B Streptococcus Indication
GBS6 is an investigational vaccine designed to help protect against Group B Streptococcus (GBS) infection. In newborns, GBS manifests as sepsis, pneumonia, and meningitis with potentially fatal outcomes for some, and long-lasting neurological damage in 46 to 50 percent of those infected.
GBS6 Group B Streptococcus Dosage
GBS6 is administered as a single intramuscular dose.
GBS6 Group B Streptococcus Updates
September 3, 2020 - The Lancet reports findings in the clinical trial NCT03170609 for GBS6 was well tolerated in healthy adults and elicited robust immune responses for all dose levels and formulations that persisted 6 months after vaccination, supporting further evaluation of GBS6 in pregnant women.
GBS6 Group B Streptococcus Clinical Trials
Clinical Trial NCT03765073: 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 (Recruiting)
- This Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various formulations) in healthy nonpregnant women (various formulations at one dose level), and then in healthy pregnant women (various formulations at three dose levels), and finally in healthy pregnant women at a selected dose level/formulation.
Clinical Trial NCT03170609: 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 Adults 18 To 49 Years Of Age (Completed)
- This is the Phase 1/2 first-in-human, randomized, placebo-controlled, observer-blinded study evaluating the investigational multivalent group B streptococcus vaccine.
- Healthy adults aged 18 to 49 years of age with no history of group B streptococcal vaccination will be randomized to receive either a single intramuscular dose of multivalent group B streptococcus vaccine (various formulations at 3 dose levels) or a placebo (saline control).