title: Safety, tolerability, and immunogenicity of inactivated trivalent seasonal influenza vaccine administered with a needle-free disposable-syringe jet injector.
abstract: BACKGROUND
  Jet injectors (JIs) avoid safety drawbacks of needle-syringe (N-S) while generating similar immune responses. A new generation of disposable-syringe jet injectors (DSJIs) overcomes the cross-contamination risk of multi-use-nozzle devices used in 20th-century campaigns. In the first study in humans, the newly-US-licensed LectraJet(®) model M3 RA DSJI was compared to N-S.
  
  
  METHODS
  Sixty healthy adults received one 0.5 mL intramuscular dose of the 2009-2010 seasonal, trivalent, inactivated influenza vaccine (TIV) in randomized, double-masked fashion by either DSJI (n=30) or N-S (n=30). Adverse reactions were monitored for 90 days after injection, and serologic responses assayed by hemagglutination inhibition (HI) at days 28 and 90.
  
  
  RESULTS
  There were no related serious adverse events (SAEs), nor differing rates of unsolicited AEs between DSJI and N-S. Solicited erythema and induration occurred more often after DSJI, but were transient and well-tolerated; a trend was noted for fewer systemic reactions by DSJI. Pre-vaccination HI geometric mean titers (GMT) increased by 28 days for H1N1, H3N2, and B antigens by 13-, 14-, and 8-fold via DSJI, and by 7-, 10-, and 7-fold for N-S, respectively. No trending differences in GMT, seroconversion, or seroprotection were noted; sample sizes precluded non-inferiority assessment.
  
  
  CONCLUSIONS
  DSJI delivery of TIV is well-tolerated and immunogenic.
authors: Division of Geomedicine, Department of Medicine, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, United States. jakub.simon@nanobio.com
authors: Jakub K
authors: JK
authors: Simon
authors: Mihaela
authors: M
authors: Carter
authors: Marcela F
authors: MF
authors: Pasetti
authors: Marcelo B
authors: MB
authors: Sztein
authors: Karen L
authors: KL
authors: Kotloff
authors: Bruce G
authors: BG
authors: Weniger
authors: James D
authors: JD
authors: Campbell
authors: Myron M
authors: MM
authors: Levine
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000096:biosynthesis; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology; D009981:Influenza B virus / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D007251:Influenza, Human / Q000276:immunology* / Q000517:prevention & control; D007273:Injections, Intramuscular; D007277:Injections, Jet / Q000009:adverse effects / Q000379:methods; D008297:Male; D008875:Middle Aged; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated