Safety and pharmacokinetics of hyperimmune anti-human immunodeficiency virus (HIV) immunoglobulin administered to HIV-infected pregnant women and their newborns

Safety and pharmacokinetics of hyperimmune anti-human immunodeficiency virus (HIV) immunoglobulin administered to HIV-infected pregnant women and their newborns

ation of malaria immunity might rather fall into the general frame of the depression of cellular immunity during pregnancy than involve a specific mal...

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ation of malaria immunity might rather fall into the general frame of the depression of cellular immunity during pregnancy than involve a specific malaria phenomenon.

Safety and pharmacokinetics of hyperimmune anti-human immunodeficiency virus (HIV) immunoglohulin administered to HIV-infected pregnant women and their newborns Lambert, J.S., Mofenson, L.M., Fletcher, C.V., Moye, J. Jr., Stiehm, E.R., Meyer III, W.A., Nemo, G.J., Mathieson, B.J., Hirsch, G., Sapan. C.V., Cummins, L.M., Jimenez, E., O’Neill, E., Kovacs, A., Stek, A. Me&d Biotechnology Center., hstitutc of’ Hun~un Virology, Unizwsity qf Mar~hmd, 725 W. Lodmd St., Bultinlow, MD 21301, USA [Journal of Infectious Diseases 17512, 2833291 (1997)] The pharmacokinetics and safety of hyperimmune anti-human immunodeficiency virus (HIV) intravenous immunoglobulin (HIVIG) were evaluated in the first 28 maternal-infant pairs enrolled in a randomized, intravenous immunoglobulin (IVIG)-controlled trial of HIVIG maternal-infant HIV transmission prophylaxis. Using 200 mg/kg, mean half-life and volume of distribution (V(d)) in women were 15 days and 72 ml/kg. respectively, after one and 3 2 days and 154 ml/kg after three monthly infusions, with stable 4 ml/kg/day clearance. Transplacental passage occurred. Newborn single-dose half-life, V(d), and clearance were 30 days, 143 ml/kg, and 4 ml/kg/day, respectively. HIVIG rapidly cleared maternal serum immune complex-dissociated p24 antigen, and plasma HIV-l RNA levels were stable. Mild to moderate adverse clinical effects occurred in 2 of 103 maternal and 2 of 25 infant infusions. No adverse hematologic, blood chemistry, or immunologic effects were seen. HIVIG is well-tolerated in HIV-infected pregnant women and their newborns, clears antigenemia, crosses the placenta, and exhibits pharmacokinetics similar to those of other immunoglobulin preparations.

The HSD-hCG vaccine prevents pregnancy in women: Feasibility study of a reversible safe contraceptive vaccine Talwar, G.P., Singh, O., Gupta, S.K., Hasnain, S.E., Pal, R., Majumdar, S.S., Vrati, S., Mukhopadhay, A.. Srinivasan, J., Deshmukh, U., Ganga, S., Mandokhot, A., Gupta, A. Inter.natiomI Centrr, Genetic Enginwring Biotechnolog-J), Ne\v Delhi 110067, In&l [American Journal of Reproductive Immunology 37/Z 1533 160 (1997)]