Pharmacokinetics of Human Tick-borne Encephalitis Virus Antibody Levels after Injection with Human Tick-borne Encephalitis Immunoglobulin, Solvent/Detergent Treated, FSME-BULIN S/D in Healthy Volunteers
Autor: | Mimika Kirgios, Heinz Leibl, Thomas Wahlberg, Oskar Enzersberger, Nils Adner |
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Rok vydání: | 2001 |
Předmět: |
Adult
Male Microbiology (medical) Health Status Immunoglobulins Antibodies Viral Injections Intramuscular Encephalitis Viruses Tick-Borne Humans Medicine Prospective Studies Neutralizing antibody General Immunology and Microbiology biology business.industry Antibody titer Tick-borne encephalitis General Medicine Middle Aged biology.organism_classification medicine.disease Virology Tick-borne encephalitis virus Flavivirus Treatment Outcome Infectious Diseases Immunology biology.protein Female Antibody business Intramuscular injection Encephalitis Tick-Borne Encephalitis |
Zdroj: | Scandinavian Journal of Infectious Diseases. 33:843-847 |
ISSN: | 1651-1980 0036-5548 |
DOI: | 10.1080/00365540110027358 |
Popis: | This study assessed tick-borne encephalitis virus (TBEV) neutralizing antibody levels after injection of FSME-BULIN S/D (human tick-borne encephalitis immunoglobulin; 0.2 ml/kg body weight) in healthy volunteers. After screening of 18 volunteers for TBEV antibody titers, 12 healthy volunteers with TBEV antibody titers < 5 were entered into the pharmacokinetic part of the study. TBEV antibody titers were analyzed before injection and after 24 h, 48 h, 3 d, 4 d and 8 d. Vital signs, adverse events and laboratory tests for safety were analyzed after intramuscular injection with the immunoglobulin at 4 sites in the gluteal muscles. Injection with 0.2 ml/kg of FSME-BULIN S/D induced a fast increase in, and sustained titers of, neutralizing antibody levels against TBEV. The injections were well tolerated and the safety profile of the product was fully acceptable. |
Databáze: | OpenAIRE |
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