title: Transplacental Transfer of Hepatitis B Neutralizing Antibody during Pregnancy in an Animal Model: Implications for Newborn and Maternal Health.
abstract: Despite the success of postexposure prophylaxis (PEP) of the newborn in preventing mother-to-child transmission of hepatitis B virus), in non-US clinical trials, administering hepatitis B immune globulin (HBIG) to mothers at the end of pregnancy (in addition to passive-active PEP of the newborn) only partially improved outcomes. That is, a significant percentage of newborns became infected during their first year of life. We used a relevant animal model for human IgG transplacental transfer to study dose, time and subclass dependence of HBV neutralizing antibody (nAb) maternal, and fetal levels at the end of pregnancy. Pregnant guinea pigs received 50 or 100 IU/kg HBIGIV 2-5 days before delivery. Human total IgG, IgG subclasses, and nAb in mothers and their litters were measured. In vitro analyses of guinea pig Fc neonatal receptor binding to HBIGIV, as well as to all human IgG subclasses, were also performed. Our study showed that nAb transferred transplacentally from the pregnant guinea pigs to their litters; no transfer occurred during parturition. The amount of the transferred nAb was dose and time dependent. Thus, selection of an efficacious dose in the clinic is important: microdosing may be underdosing, particularly in cases of high viraemia.
authors.affiliation: Laboratory of Plasma Derivatives, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA 1401 Rockville Pike, Rockville, MD 20852, USA.
authors.forename: Li
authors.initials: L
authors.lastname: Ma
authors.affiliation: Laboratory of Plasma Derivatives, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA 1401 Rockville Pike, Rockville, MD 20852, USA.
authors.forename: Malgorzata G
authors.initials: MG
authors.lastname: Norton
authors.affiliation: Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA 1401 Rockville Pike, Rockville, MD 20852, USA.
authors.forename: Iftekhar
authors.initials: I
authors.lastname: Mahmood
authors.affiliation: Laboratory of Plasma Derivatives, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA 1401 Rockville Pike, Rockville, MD 20852, USA.
authors.forename: Zhong
authors.initials: Z
authors.lastname: Zhao
authors.affiliation: Laboratory of Plasma Derivatives, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA 1401 Rockville Pike, Rockville, MD 20852, USA.
authors.forename: Lilin
authors.initials: L
authors.lastname: Zhong
authors.affiliation: Laboratory of Plasma Derivatives, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA 1401 Rockville Pike, Rockville, MD 20852, USA.
authors.forename: Pei
authors.initials: P
authors.lastname: Zhang
authors.affiliation: Laboratory of Plasma Derivatives, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA 1401 Rockville Pike, Rockville, MD 20852, USA.
authors.forename: Evi B
authors.initials: EB
authors.lastname: Struble