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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
6
|
pubmed:dateCreated |
1991-7-2
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pubmed:abstractText |
The safety and pharmacokinetics of the two neutralizing human IgG1 monoclonal antibodies to cytomegalovirus (CMV) SDZ 89-104 and 89-109 in bone marrow transplant (BMT) recipients was assessed in an open phase I trial. Thirteen patients, 8 seropositive and 5 seronegative for CMV, were treated with allogeneic or autologous bone marrow transplantation. SDZ 89-104 was given to 5 and SDZ 89-109 to 8 patients. Patients were divided into high- and low-dose groups. A fixed prestudy dose of 0.1 mg/kg was given 4 days before BMT. On days 3, 17, 31, 45, 59, and 73, patients were treated with either 0.5 or 2 mg/kg of the respective antibody. Results indicate that doses of 2 mg/kg of SDZ 89-104 or SDZ 89-109 in alternating weeks can be safely administered to BMT patients. Serum trough levels measured by antiidiotype ELISA were approximately 10 micrograms/ml after administration of 0.5 mg/kg and approximately 50 micrograms/ml after treatment with 2 mg/kg of SDZ 89-104 or SDZ 89-109. High serum levels defined by antiidiotype ELISA techniques closely paralleled increased neutralizing activity. Serum half-lives calculated from these data were approximately 6 days.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
AIM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
Jun
|
pubmed:issn |
0022-1899
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pubmed:author | |
pubmed:issnType |
Print
|
pubmed:volume |
163
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pubmed:owner |
NLM
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pubmed:authorsComplete |
N
|
pubmed:pagination |
1344-7
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pubmed:dateRevised |
2006-11-15
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pubmed:meshHeading |
pubmed-meshheading:1645384-Adolescent,
pubmed-meshheading:1645384-Adult,
pubmed-meshheading:1645384-Antibodies, Monoclonal,
pubmed-meshheading:1645384-Bone Marrow Transplantation,
pubmed-meshheading:1645384-Cytomegalovirus,
pubmed-meshheading:1645384-Cytomegalovirus Infections,
pubmed-meshheading:1645384-Drug Evaluation,
pubmed-meshheading:1645384-Enzyme-Linked Immunosorbent Assay,
pubmed-meshheading:1645384-Female,
pubmed-meshheading:1645384-Half-Life,
pubmed-meshheading:1645384-Humans,
pubmed-meshheading:1645384-Immunization, Passive,
pubmed-meshheading:1645384-Male,
pubmed-meshheading:1645384-Middle Aged
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pubmed:year |
1991
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pubmed:articleTitle |
Human monoclonal antibodies neutralizing cytomegalovirus (CMV) for prophylaxis of CMV disease: report of a phase I trial in bone marrow transplant recipients.
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pubmed:affiliation |
Division of Clinical Immunobiology (Department of Internal Medicine), University Hospital Innsbruck, Austria.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Research Support, U.S. Gov't, P.H.S.,
Controlled Clinical Trial
|