Maternal immunization with Group B Streptococcus six-valent polysaccharide conjugate vaccine supported by lack of toxicity in rat and rabbit fertility and developmental toxicity studies.

Autor: Catlin NR; Drug Safety Research and Development, Pfizer Worldwide Research and Development, Groton, Connecticut, USA., Cappon GD; Drug Safety Research and Development, Pfizer Worldwide Research and Development, Groton, Connecticut, USA., Engel S; Drug Safety Research and Development, Pfizer Worldwide Research and Development, Groton, Connecticut, USA., Rohde C; Drug Safety Research and Development, Pfizer Worldwide Research and Development, Pearl River, New York, USA., Nowland WS; Drug Safety Research and Development, Pfizer Worldwide Research and Development, Groton, Connecticut, USA., Buitrago S; Vaccine Research and Development, Pfizer Worldwide Research and Development, Pearl River, New York, USA., Scully I; Vaccine Research and Development, Pfizer Worldwide Research and Development, Pearl River, New York, USA., Anderson AS; Vaccine Research and Development, Pfizer Worldwide Research and Development, Pearl River, New York, USA., Bowman CJ; Drug Safety Research and Development, Pfizer Worldwide Research and Development, Groton, Connecticut, USA.
Jazyk: angličtina
Zdroj: Birth defects research [Birth Defects Res] 2021 Nov 15; Vol. 113 (19), pp. 1343-1356. Date of Electronic Publication: 2021 Sep 13.
DOI: 10.1002/bdr2.1953
Abstrakt: A maternal Group B Streptococcus (GBS) six-valent polysaccharide conjugate vaccine (GBS6) is being developed to protect neonates and infants up to 3 months of age through passive transfer of antibodies from the mother to the infant. Fertility and developmental toxicity studies were conducted in female Sprague Dawley rats and New Zealand White rabbits with GBS6 (20 μg capsular polysaccharide/serotype formulated with or without AlPO 4 , the highest clinical dose). Females were administered the full human dose of the GBS6 formulation intramuscularly twice prior to mating and twice during gestation, to ensure that high antibody levels were maintained throughout gestation and lactation. Approximately, half of the rats and rabbits were evaluated at the end of gestation, and the remainder were evaluated at the end of lactation. Maternal blood for GBS6 serology, to measure antibody titers to the GBS6 antigens, was collected prior to the first dose, prior to mating, and at each necropsy. Blood for serology was also collected from offspring at the end of gestation and lactation. In both species, there was no evidence of vaccine-related effects on fertility, embryo-fetal development, or postnatal development of the offspring, supporting regulatory guidance that single-species evaluation would have been sufficient. Functional serum antibodies to all six serotypes in the vaccine were confirmed in maternal animals and functional serum antibodies to one or more of the six serotypes was also confirmed in some rat offspring and most of the rabbit offspring. The results of these studies supported the safety of GBS6 vaccine administration to pregnant women.
(© 2021 Wiley Periodicals LLC.)
Databáze: MEDLINE
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