title: In vitro assessment of the allergenicity of novel MF59-adjuvanted pandemic H1N1 influenza vaccine produced in dog kidney cells.
abstract: A licensed inactivated MF59-adjuvanted seasonal influenza vaccine (Optaflu) produced in canine kidney cells (MDCK 33016-PF) contained no egg proteins and did not trigger degranulation in rat basophilic leukemia (RBL) cells passively sensitized with human anti-dog IgE, supporting its safe use in dog-allergic individuals. The cell-derived pandemic H1N1 influenza vaccine was also adjuvanted with the emulsion adjuvant MF59, and support for its similar safe use was sought. We sought to evaluate in vitro allergenicity of the MF59-adjuvanted cell-derived pandemic H1N1 influenza vaccine in subjects with dog allergy, with a mediator release assay. RBL-2H3 cells transfected with human Fcε receptor type 1 were sensitized with sera from adult dog-allergic subjects and stimulated with serial dilutions of pandemic H1N1 influenza vaccine and dog dander extract. β-N-hexosaminidase release (NHR) was used as a marker of RBL degranulation.. Median dog dander-specific IgE in 30 dog-allergic subjects was 27.7 kU(A)/L (range 10.1; > 100); and in 5 dog non-allergic subjects was < 0.35 kU(A)/L (UniCAP system). Median (range) maximum NHR in dog-allergic subjects was: pandemic H1N1 influenza vaccine 1.1% (0; 4.4) and dog dander 6.9% (0.7; 37.3), P < 0.001. In conclusion, MF59-adjuvanted pandemic H1N1 influenza vaccine produced in continuous canine kidney cells did not trigger degranulation in RBL cells passively sensitized with human anti-dog IgE, supporting its safe use in dog-allergic individuals.
authors: Mount Sinai School of Medicine, New York, NY, USA. ramonbencharitiwong@gmail.com
authors: Ramon
authors: R
authors: Bencharitiwong
authors: Stephanie
authors: S
authors: Leonard
authors: Theodore
authors: T
authors: Tsai
authors: Anna
authors: A
authors: Nowak-Węgrzyn
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects*; D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000276:immunology; D000818:Animals; D018929:Cell Culture Techniques; D015550:Cell Degranulation; D002460:Cell Line; D004285:Dogs; D004342:Drug Hypersensitivity / Q000453:epidemiology*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D053118:Influenza A Virus, H1N1 Subtype / Q000254:growth & development / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000302:isolation & purification; D007251:Influenza, Human / Q000517:prevention & control / Q000821:virology; D008297:Male; D008875:Middle Aged; D058873:Pandemics / Q000517:prevention & control; D011136:Polysorbates / Q000008:administration & dosage / Q000009:adverse effects*; D051381:Rats; D013185:Squalene / Q000008:administration & dosage / Q000009:adverse effects*; D013678:Technology, Pharmaceutical; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000485:Allergens; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D007073:Immunoglobulin E; D013185:Squalene