{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T07:29:59Z","timestamp":1792740599919,"version":"4.5.0"},"reference-count":29,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2018,10,3]],"date-time":"2018-10-03T00:00:00Z","timestamp":1538524800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["N01-AI-25495"],"award-info":[{"award-number":["N01-AI-25495"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,5,30]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Healthy, nonpregnant women aged 18\u201340 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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%\u201358%; 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 \u00b5g\/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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>NCT00128219.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciy838","type":"journal-article","created":{"date-parts":[[2018,9,28]],"date-time":"2018-09-28T22:12:10Z","timestamp":1538172730000},"page":"2079-2086","source":"Crossref","is-referenced-by-count":46,"title":["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"],"prefix":"10.1093","volume":"68","author":[{"given":"Sharon L","family":"Hillier","sequence":"first","affiliation":[{"name":"University of Pittsburgh School of Medicine, Magee-Womens Hospital, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Ferrieri","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine and Pathology and Pediatrics, University of Minnesota Medical School, Minneapolis"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morven S","family":"Edwards","sequence":"first","affiliation":[{"name":"Baylor College of Medicine, Department of Pediatrics, Feigin Center, Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marian","family":"Ewell","sequence":"first","affiliation":[{"name":"The EMMES Corporation, Rockville, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daron","family":"Ferris","sequence":"first","affiliation":[{"name":"Medical College of Georgia, Augusta"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Fine","sequence":"first","affiliation":[{"name":"Planned Parenthood Gulf Coast, Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincent","family":"Carey","sequence":"first","affiliation":[{"name":"Channing Division of Network Medicine, Department of Medicine, Brigham and Women\u2019s Hospital and Harvard Medical School, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leslie","family":"Meyn","sequence":"first","affiliation":[{"name":"University of Pittsburgh School of Medicine, Magee-Womens Hospital, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dakota","family":"Hoagland","sequence":"first","affiliation":[{"name":"COTA Enterprises, McLouth, Kansas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dennis L","family":"Kasper","sequence":"first","affiliation":[{"name":"Division of Immunology, Department of Microbiology and Immunobiology, Harvard Medical School, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence C","family":"Paoletti","sequence":"first","affiliation":[{"name":"Division of Immunology, Department of Microbiology and Immunobiology, Harvard Medical School, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather","family":"Hill","sequence":"first","affiliation":[{"name":"The EMMES Corporation, Rockville, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carol J","family":"Baker","sequence":"first","affiliation":[{"name":"Divsion of Infectious Disease, Department of Pediatrics, University of Texas Health Science Center McGovern Medical School, Houston"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2018,10,3]]},"reference":[{"key":"2020062908034992700_CIT0001","doi-asserted-by":"crossref","first-page":"2056","DOI":"10.1001\/jama.299.17.2056","article-title":"Epidemiology of invasive group B streptococcal disease in the United States, 1999\u20132005. 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