title: Needle-free jet injector intradermal delivery of fractional dose inactivated poliovirus vaccine: Association between injection quality and immunogenicity.
abstract: BACKGROUND
  The World Health Organization recommends that as part of the polio end-game strategy a dose of inactivated poliovirus vaccine (IPV) be introduced by the end of 2015 in all countries currently using only oral poliovirus vaccine (OPV). Administration of fractional dose (1/5 of full dose) IPV (fIPV) by intradermal (ID) injection may reduce costs, but its conventional administration is with Bacillus Calmette-Guerin (BCG) needle and syringe (NS), which is time consuming and technically challenging. We compared injection quality achieved with BCG NS and three needle-free jet injectors and assessed ergonomic features of the injectors.
  
  
  METHODS
  Children between 12 and 20 months of age who had previously received OPV were enrolled in the Camaguey, Cuba study. Subjects received a single fIPV dose administered intradermally with BCG NS or one of three needle-free injector devices: Bioject Biojector 2000® (B2000), Bioject ID Pen® (ID Pen), or PharmaJet Tropis® (Tropis). We measured bleb diameter and vaccine loss as indicators of ID injection quality, with desirable injection quality defined as bleb diameter ≥5mm and vaccine loss <10%. We surveyed vaccinators to evaluate ergonomic features of the injectors. We further assessed the injection quality indicators as predictors of immune response, measured by increase in poliovirus neutralizing antibodies in blood between day 0 (pre-IPV) and 21 (post-vaccination).
  
  
  RESULTS
  Delivery by BCG NS and Tropis resulted in the highest proportion of subjects with desirable injection quality; health workers ranked Biojector2000 and Tropis highest for ergonomic features. We observed that vaccine loss and desirable injection quality were associated with an immune response for poliovirus type 2 (P=0.02, P=0.01, respectively).
  
  
  CONCLUSIONS
  Our study demonstrated the feasibility of fIPV delivery using needle-free injector devices with high acceptability among health workers. We did not observe the indicators of injection quality to be uniformly associated with immune response.
authors.affiliation: Pedro Kouri Institute of Tropical Medicine, Havana, Cuba.
authors.forename: Sonia
authors.initials: S
authors.lastname: Resik
authors.affiliation: Centro Provincial de Higiene, Epidemiologia y Microbilogia, Camaguey, Cuba.
authors.forename: Alina
authors.initials: A
authors.lastname: Tejeda
authors.affiliation: The World Health Organization, Geneva, Switzerland. Electronic address: macho@who.int.
authors.forename: Ondrej
authors.initials: O
authors.lastname: Mach
authors.affiliation: The World Health Organization, Geneva, Switzerland.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Sein
authors.affiliation: The World Health Organization, Geneva, Switzerland.
authors.forename: Natalie
authors.initials: N
authors.lastname: Molodecky
authors.affiliation: PATH, Seattle, WA, USA.
authors.forename: Courtney
authors.initials: C
authors.lastname: Jarrahian
authors.affiliation: PATH, Seattle, WA, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Saganic
authors.affiliation: PATH, Seattle, WA, USA.
authors.forename: Darin
authors.initials: D
authors.lastname: Zehrung
authors.affiliation: Pedro Kouri Institute of Tropical Medicine, Havana, Cuba.
authors.forename: Magile
authors.initials: M
authors.lastname: Fonseca
authors.affiliation: Pedro Kouri Institute of Tropical Medicine, Havana, Cuba.
authors.forename: Manuel
authors.initials: M
authors.lastname: Diaz
authors.affiliation: Centro Provincial de Higiene, Epidemiologia y Microbilogia, Camaguey, Cuba.
authors.forename: Nilda
authors.initials: N
authors.lastname: Alemany
authors.affiliation: Centro Provincial de Higiene, Epidemiologia y Microbilogia, Camaguey, Cuba.
authors.forename: Gloria
authors.initials: G
authors.lastname: Garcia
authors.affiliation: Pedro Kouri Institute of Tropical Medicine, Havana, Cuba.
authors.forename: Lai Heng
authors.initials: LH
authors.lastname: Hung
authors.affiliation: Pedro Kouri Institute of Tropical Medicine, Havana, Cuba.
authors.forename: Yenisleydis
authors.initials: Y
authors.lastname: Martinez
authors.affiliation: The World Health Organization, Geneva, Switzerland.
authors.forename: Roland W
authors.initials: RW
authors.lastname: Sutter
mesh_terms: D003462:Cuba; D005260:Female; D006801:Humans; D007223:Infant; D007271:Injections, Intradermal / Q000379:methods*; D007277:Injections, Jet / Q000379:methods*; D008297:Male; D008969:Molecular Sequence Data; D011051:Poliomyelitis / Q000517:prevention & control*; D017955:Poliovirus / Q000276:immunology; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage* / Q000276:immunology*; D017422:Sequence Analysis, DNA
chemical_list: D011054:Poliovirus Vaccine, Inactivated
keywords: Cuba; Needle-free injector; Poliomyelitis