Document Detail

Developmental toxicity testing of vaccines.
MedLine Citation:
PMID:  23138897     Owner:  NLM     Status:  In-Data-Review    
Preventative and therapeutic vaccines are increasingly used during pregnancy and present special considerations for developmental toxicity testing. The various components of the vaccine formulation (i.e., protein or polysaccharide antigen, adjuvants, and excipients) need to be assessed for direct effects on the developing conceptus. In addition, possible adverse influences of the induced antibodies on fetal and/or postnatal development need to be evaluated. A guidance document on the preclinical testing of preventative and therapeutic vaccines for developmental toxicity was issued by the FDA in 2006. Preclinical studies are designed to assess possible influences of vaccines on pre- and postnatal development. The choice of model animal for these experiments is influenced by species differences in the timing and extent of the transfer of the induced maternal antibodies to the fetus. The cross-placental transport of maternal immunoglobulins generally only occurs in late gestation and tends to be greater in humans and monkeys than in non-primate species. For many vaccines, the rabbit shows a greater rate of prenatal transfer of the induced antibodies than rodents. For biotechnology-derived vaccines that are not immunogenic in lower species, nonhuman primates may be the only appropriate models. It may be advisable to test new adjuvants using the ICH study designs for conventional pharmaceuticals in addition to the developmental toxicity study with the final vaccine formulation.
Paul C Barrow; Linda Allais
Related Documents :
21093497 - Analysis of porcine circovirus type 1 detected in rotarix vaccine.
7354427 - New compounds: derivatives of fluorene xxxvii: 9-substituted 3-nitrofluorenes.
21412797 - Phenotypic and genomic analysis of serotype 3 sabin poliovirus vaccine produced in mrc-...
4396127 - Beta-adrenoceptor antagonist activity of 3-methoxyisoprenaline.
15629357 - Epitope analysis for influenza vaccine design.
12669247 - Tumor-derived chaperone-rich cell lysates are effective therapeutic vaccines against a ...
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Methods in molecular biology (Clifton, N.J.)     Volume:  947     ISSN:  1940-6029     ISO Abbreviation:  Methods Mol. Biol.     Publication Date:  2013  
Date Detail:
Created Date:  2012-11-09     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9214969     Medline TA:  Methods Mol Biol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  81-9     Citation Subset:  IM    
CiToxLAB, Evreux, France,
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Previous Document:  The teratology testing of food additives.
Next Document:  The teratology testing of cosmetics.