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.
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.
Adner
N
N
Metabolic Laboratory, South Hospital, Stockholm, Sweden.
Leibl
H
H
Enzersberger
O
O
Kirgios
M
M
Wahlberg
T
T
D000328:Adult; D000914:Antibodies, Viral / Q000008:administration & dosage / Q000378:metabolism* / Q000627:therapeutic use*; D004669:Encephalitis Viruses, Tick-Borne / Q000276:immunology*; D004675:Encephalitis, Tick-Borne / Q000628:therapy*; D005260:Female; D006304:Health Status; D006801:Humans; D007136:Immunoglobulins / Q000008:administration & dosage / Q000378:metabolism* / Q000627:therapeutic use*; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
D000914:Antibodies, Viral; D007136:Immunoglobulins