{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T02:55:59Z","timestamp":1783479359720,"version":"3.55.0"},"reference-count":23,"publisher":"American Society for Microbiology","issue":"10","license":[{"start":{"date-parts":[[2005,10,1]],"date-time":"2005-10-01T00:00:00Z","timestamp":1128124800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Antimicrob Agents Chemother"],"published-print":{"date-parts":[[2005,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>Nosocomial or late-onset sepsis is a common complication among premature infants, with a frequency inversely correlated with birth weight. Increased susceptibility to infection is due in part to an immature humoral (antibody-mediated) immune response. This study investigated the pharmacokinetics (PKs) and safety of a donor-selected specific intravenous immune globulin (IVIG) preparation, INH-A21 (Veronate), for prevention of sepsis in premature infants. Thirty-six infants weighing between 500 and 1,250 g during the first postnatal week were eligible to begin a series of up to four intravenous infusions of 500 or 750 mg\/kg of body weight INH-A21. Blood samples were analyzed for antibodies against the Ser-Asp dipeptide repeat G (SdrG) and clumping factor A (ClfA) surface proteins of staphylococci. Sparse sampling and population PK analyses were performed to derive PK parameters. Following administration of the 500- and 750-mg\/kg doses, the estimated average steady-state levels of anti-ClfA were 6.1 U\/ml and 9.2 U\/ml, respectively, and those of anti-SdrG were 5.2 U\/ml and 7.7 U\/ml, respectively. The elimination half-lives for anti-ClfA and anti-SdrG were 719 h and 701 h, respectively, and the clearances were 0.18 ml\/h and 0.21 ml\/h, respectively. In the final model, the values of the PK parameters were independent of gestational age. Both doses of INH-A21 were well tolerated, and the safety profile was similar to those of other IVIG preparations. These results suggest that a shorter dosing interval should be utilized between the first and second doses to achieve and maintain higher titers of anti-ClfA and anti-SdrG antibodies. Further studies examining INH-A21 for the prevention of late-onset sepsis in infants within the weight range studied are warranted.<\/jats:p>","DOI":"10.1128\/aac.49.10.4121-4127.2005","type":"journal-article","created":{"date-parts":[[2005,9,27]],"date-time":"2005-09-27T16:28:08Z","timestamp":1127838488000},"page":"4121-4127","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":17,"title":["Multicenter Study To Determine Antibody Concentrations and Assess the Safety of Administration of INH-A21, a Donor-Selected Human Staphylococcal Immune Globulin, in Low-Birth-Weight Infants"],"prefix":"10.1128","volume":"49","author":[{"given":"Edmund V.","family":"Capparelli","sequence":"first","affiliation":[{"name":"Trials-by-Design L.L.C., San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barry T.","family":"Bloom","sequence":"additional","affiliation":[{"name":"Wesley Medical Center, Wichita, Kansas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom J.","family":"Kueser","sequence":"additional","affiliation":[{"name":"Carolina's Medical Center, Charlotte, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David G.","family":"Oelberg","sequence":"additional","affiliation":[{"name":"Eastern Virginia Medical School, Norfolk, Virginia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellen M.","family":"Bifano","sequence":"additional","affiliation":[{"name":"UMU\u2014Syracuse, Syracuse, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert D.","family":"White","sequence":"additional","affiliation":[{"name":"Memorial Hospital, South Bend, Indiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert L.","family":"Schelonka","sequence":"additional","affiliation":[{"name":"University of Alabama, Birmingham, Alabama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen A.","family":"Pearlman","sequence":"additional","affiliation":[{"name":"Christiana Care Health System, Newark, New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Patti","sequence":"additional","affiliation":[{"name":"Inhibitex, Inc., Alpharetta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seth V.","family":"Hetherington","sequence":"additional","affiliation":[{"name":"Inhibitex, Inc., Alpharetta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1542\/peds.99.1.93"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199207233270401"},{"key":"e_1_3_2_4_2","doi-asserted-by":"crossref","first-page":"446","DOI":"10.1542\/peds.103.2.446","volume":"103","year":"1999","unstructured":"Barton, L., J. 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