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Journal of Immunology Research
Volume 2017 (2017), Article ID 7373196, 8 pages
Research Article

Passive Immunoprophylaxis for the Protection of the Mother and Her Baby: Insights from In Vivo Models of Antibody Transport

1Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, CBER/FDA, Plasma Derivatives Branch, Silver Spring, MD, USA
2Division of Clinical Evaluation and Pharmacology/Toxicology, Office of Tissues and Advanced Therapies, CBER/FDA, Silver Spring, MD, USA

Correspondence should be addressed to Evi B. Struble

Received 26 August 2016; Accepted 21 November 2016; Published 11 January 2017

Academic Editor: Roberta A. Diotti

Copyright © 2017 Yanqun Xu et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Pregnant women are at high risk for infection by pathogens. Vertical transmission of infectious agents, such as Zika, hepatitis B, and cytomegalovirus during pregnancy, remains a public health problem, associated with dire outcomes for the neonate. Thus, a safe prophylactic and therapeutic approach for protecting the mother and the neonate from infections remains a high priority. Our work is focused on better understanding the safety and efficacy determinants of IgG antibody preparations when used during pregnancy to benefit the mother and her baby. Using pregnant guinea pigs, we demonstrated that biodistribution of administered IgG to the fetus increases with gestation and results in lower maternal and higher fetal antibody concentrations as pregnancy progresses. Data suggests that partition of antibody immunotherapy to the fetal compartment may contribute to a lower maternal exposure (as measured by the AUC) and a shorter mean residence time of the IgG therapeutic at the end of pregnancy compared to nonpregnant age-matched controls, irrespective of the administered dose. Our studies provide insights on the importance of selecting an efficacious dose in pregnancy that takes into account IgG biodistribution to the fetus. The use of appropriate animal models of placental transfer and infectious disease during pregnancy would facilitate pharmacokinetic modeling to derive a starting dose in clinical trials.