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Clin Infect Dis. 2019 May 30;68(12):2079-2086. doi: 10.1093/cid/ciy838.

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.

Author information

1
University of Pittsburgh School of Medicine, Magee-Womens Hospital, Pennsylvania.
2
Department of Laboratory Medicine and Pathology and Pediatrics, University of Minnesota Medical School, Minneapolis.
3
Baylor College of Medicine, Department of Pediatrics, Feigin Center, Houston, Texas.
4
The EMMES Corporation, Rockville, Maryland.
5
Medical College of Georgia, Augusta.
6
Planned Parenthood Gulf Coast, Houston, Texas.
7
Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
8
COTA Enterprises, McLouth, Kansas.
9
Division of Immunology, Department of Microbiology and Immunobiology, Harvard Medical School, Boston, Massachusetts.
10
Divsion of Infectious Disease, Department of Pediatrics, University of Texas Health Science Center McGovern Medical School, Houston.

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.

KEYWORDS:

GBS; rectal colonization; vaccine; vaginal colonization

PMID:
30281066
DOI:
10.1093/cid/ciy838

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