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Blood, 1 June 2004, Vol. 103, No. 11, pp. 4028-4035.
Prepublished online as a Blood First Edition Paper on February 19, 2004; DOI 10.1182/blood-2003-11-3929.

Submitted November 17, 2003
Accepted February 2, 2004
A single recombinant anti-RhD IgG prevents Rhesus D immunization: association of RhD positive red blood cell clearance rate with polymorphisms in the Fc RIIA and IIIA genes
Sylvia MIESCHER*, Martin O SPYCHER, Hanspeter AMSTUTZ, Masja De HAAS, Marion KLEIJER, Ulrich J KALUS, Harmut RADTKE, Alphonse HUBSCH, Irmgard ANDRESEN, Roland M MARTIN, and Johann BICHLER
R & D, ZLB Bioplasma AG, BERN, Switzerland; Inselspital, Inst. of Immunology, BERN, Switzerland
R & D, ZLB Bioplasma AG, BERN, Switzerland
Division CLB, Sanquin, AMSTERDAM, The Netherlands
Transfusion Medicine, University Clinics Charite, BERLIN, Germany
* Corresponding author; email: sylvia.miescher{at}dkf6.unibe.ch.
A single recombinant IgG1 anti-RhD antibody (MonoRho®) was compared with a currently used polyclonal anti-RhD product (Rhophylac®) in a Phase I study for safety, efficacy of Rhesus D positive red blood cell (RBC) clearance and prevention of RhD immunization in RhD negative men challenged with 15ml of RhD positive RBC. Both the polyclonal product and recombinant anti-RhD effectively cleared RhD positive RBC after intravenous and intramuscular injection. The recombinant anti-RhD demonstrated a slower clearance rate compared to the polyclonal anti-RhD. There was no dose response and considerable variation amongst subjects who received the same dose of recombinant anti-RhD. Interestingly, RhD positive RBC clearance rates were strongly associated with Fc RIIA, IIIA but not IIIB polymorphisms. Subjects homozygous for Fc RIIA-131H or Fc RIIIA-158V allotypes showed a faster clearance rate compared to both the heterozygote and the corresponding alternative homozygote allotypes. A similar but less marked trend was seen for the polyclonal anti-RhD. Despite the variation in clearance rates there was no evidence of anti-RhD alloantibodies in any of the subjects at +6 months after the RBC challenge.

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