Reproductive toxicity of BioThrax in rabbits.
BACKGROUND
An increasing number of women are being vaccinated during child-bearing years, including vaccination with BioThrax (Anthrax Vaccine Adsorbed, or AVA). As only a limited number of studies exist in humans that have examined the effects of AVA on reproductive health, this study was conducted in order to evaluate the impact AVA vaccination may have on pregnant female rabbits and their offspring.


METHODS
Two hundred female rabbits were vaccinated with saline, adjuvant, or AVA twice prior to mating and on one of two occasions during gestation, in order to have exposure to the antigen during organogenesis. Blood samples were collected from does and fetuses/kits to assess the development and in utero transfer of antibodies to Bacillus anthracis protective antigen (anti-PA IgG). Half of the does underwent Caesarean-sectioning on gestation day 29 and a gross necropsy was performed on both the does and their fetuses. The other half were allowed to naturally deliver and gross necropsy of the does and their kits was performed on lactation day 29.


RESULTS
ELISA results showed that anti-PA IgG was generated by the does and passed to the fetuses/kits at detectable levels.


CONCLUSIONS
AVA directly, or indirectly through the production of anti-PA IgG, did not appear to have an adverse effect on the pregnant females or their offspring, as measured by mating and fertility indices, natural delivery observations, clinical signs, gross lesions, in utero growth and survival, morphological development, or kit viability.
Franco
Cynthia
C
Emergent BioSolutions, Lansing, Michigan 48906, USA. francoc@ebsi.com
Lewis
Elise
E
Morseth
Sandra
S
Simon
Louise
L
Waytes
A Thomas
AT
D000276:Adjuvants, Immunologic / Q000633:toxicity; D000536:Aluminum Hydroxide / Q000633:toxicity; D000818:Animals; D022122:Anthrax Vaccines / Q000276:immunology / Q000633:toxicity*; D000907:Antibodies, Bacterial / Q000097:blood*; D000942:Antigens, Bacterial / Q000276:immunology*; D001427:Bacterial Toxins / Q000276:immunology*; D004622:Embryo, Mammalian / Q000187:drug effects* / Q000276:immunology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D047109:Fetal Development / Q000187:drug effects; D018811:Maternal Exposure; D008431:Maternal-Fetal Exchange / Q000276:immunology; D011247:Pregnancy; D011817:Rabbits; D012098:Reproduction / Q000187:drug effects* / Q000276:immunology; D014614:Vaccines, Synthetic / Q000276:immunology / Q000633:toxicity*
D000276:Adjuvants, Immunologic; D022122:Anthrax Vaccines; D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D001427:Bacterial Toxins; D014614:Vaccines, Synthetic; C030325:anthrax toxin; D000536:Aluminum Hydroxide