title: A simplified mycobacterial growth inhibition assay (MGIA) using direct infection of mouse splenocytes and the MGIT system.
abstract: We describe a simplified Mycobacterial Growth Inhibition Assay (MGIA) for pre-clinical assessment of vaccine-mediated protection in mice. The assay is accomplished by directly infecting splenocytes from vaccinated mice with Mycobacterium tuberculosis and quantifying mycobacteria using Mycobacterial Growth Indicator Tubes (MGIT). Vaccine-mediated immunogenicity detected by this assay correlated with protection.
authors.affiliation: Center for Biologics Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Amy L
authors.initials: AL
authors.lastname: Yang
authors.affiliation: Center for Biologics Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Schmidt
authors.affiliation: Center for Biologics Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Stibitz
authors.affiliation: Center for Biologics Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA. Electronic address: steven.derrick@fda.hhs.gov.
authors.forename: Steven C
authors.initials: SC
authors.lastname: Derrick
authors.affiliation: Center for Biologics Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Sheldon L
authors.initials: SL
authors.lastname: Morris
authors.affiliation: Center for Biologics Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Marcela
authors.initials: M
authors.lastname: Parra
mesh_terms: D000818:Animals; D001500:BCG Vaccine / Q000276:immunology*; D001431:Bacteriological Techniques / Q000379:methods*; D002478:Cells, Cultured; D015169:Colony Count, Microbial; D003141:Communicable Diseases / Q000175:diagnosis*; D003470:Culture Media; D004195:Disease Models, Animal; D004341:Drug Evaluation; D051379:Mice; D009161:Mycobacterium / Q000254:growth & development*; D009169:Mycobacterium tuberculosis / Q000254:growth & development; D013154:Spleen / Q000276:immunology / Q000382:microbiology*; D014376:Tuberculosis / Q000276:immunology
chemical_list: D001500:BCG Vaccine; D003470:Culture Media
keywords: BCG; MGIA; MGIT; Tuberculosis; Vaccine