A Phase 2, Randomized, Control Trial of Group B Streptococcus (GBS) Type III Capsular Polysaccharide-tetanus Toxoid (GBS III-TT) Vaccine to Prevent Vaginal Colonization With GBS III. (3rd October 2018)

• Record Type: Journal Article
• Authors: Hillier, Sharon L; Ferrieri, Patricia; Edwards, Morven S; Ewell, Marian; Ferris, Daron; Fine, Paul; Carey, Vincent; Meyn, Leslie; Hoagland, Dakota; Kasper, Dennis L; Paoletti, Lawrence C; Hill, Heather; Baker, Carol J
• Is Part Of: Clinical infectious diseases. Volume 68:Number 12(2019)
• Page Start: 2079
• Page End: 2086
• Publication Date: 2018-10-03
• Subjects: GBS -- vaccine -- vaginal colonization -- rectal colonization; Communicable diseases -- Periodicals; 616.905
• DOI: 10.1093/cid/ciy838
• Languages: English
• ISSNs: 1058-4838

Abstract

Abstract: Background: Group B Streptococcus (GBS) frequently colonizes pregnant women and can cause sepsis and meningitis in young infants. If colonization was prevented through maternal immunization, a reduction in perinatal GBS disease might be possible. A GBS type III capsular polysaccharide (CPS)-tetanus toxoid conjugate (III-TT) vaccine was evaluated for safety and efficacy in preventing acquisition of GBS colonization. Methods: Healthy, nonpregnant women aged 18–40 years and screened to be GBS III vaginal and rectal culture negative were randomized to receive III-TT conjugate or tetanus diphtheria toxoid vaccine in a multicenter, observer-blinded trial. GBS vaginal and rectal cultures and blood were obtained bimonthly over 18 months. Serum concentrations of GBS III CPS-specific antibodies were determined using enzyme-linked immunosorbent assay. Results: Among 1525 women screened, 650 were eligible for the intent-to-treat analysis. For time to first acquisition of vaginal GBS III, vaccine efficacy was 36% (95% confidence interval [CI], 1%–58%; P = .044), and for first rectal acquisition efficacy was 43% (95% CI, 11% to 63%; P = .014). Two months post-immunization, geometric mean concentrations of serum GBS type III CPS-specific immunoglobulin G were 12.6 µg/mL (95% CI, 9.95 to 15.81) in GBS III-TT recipients, representing a 4-fold increase from baseline in 95% of women, which persisted. Both vaccines were well tolerated. Conclusions: GBS CPS III-TT conjugate vaccine significantly delayed acquisition of vaginal and rectal GBS III colonization. In addition to its use for maternal immunization to passively protect infants with maternally derived antibodies, a multivalent vaccine might also serve to reduce fetal and neonatal exposure to GBS. Clinical Trials Registration: NCT00128219. Abstract : Group B streptococcal (GBS) type III conjugate vaccine significantly decreased acquisition of vaginal and rectal colonization in women. Maternal immunization with a multivalent GBS vaccine may prevent perinatal exposure, thus augmenting prevention through placental transport of maternal GBS-specific antibodies.