title: Intradermal fractional booster dose of inactivated poliomyelitis vaccine with a jet injector in healthy adults.
abstract: For global eradication of poliomyelitis, inactivated poliovirus vaccine (IPV) needs to become available in all countries. Using fractional-doses (reduced-doses) may impact affordability and optimize the utilization of the production capacity. Intradermal administration has the potential to lower the dose without reducing immunogenicity. A needle-free jet injector may be a reliable way to administer vaccines intradermally. The primary objective of this randomized controlled trial was to compare the immunogenicity and tolerability of fractional-dose intradermal IPV (Netherlands Vaccine Institute, NVI) booster vaccination administered with a jet injector (PharmaJet) to full-dose and fractional-dose intramuscular vaccination with a needle and syringe. Immunogenicity was assessed by comparing the differences in the post-vaccination log2 geometric mean concentrations of neutralizing antibodies (GMC) between the study groups. A total of 125 Dutch adult volunteers with a well-documented vaccination history were randomized to one of four groups: full-dose intramuscular needle (IM-NS-0.5), full-dose intramuscular jet injector (IM-JI-0.5), 1/5th dose intramuscular needle (IM-NS-0.1), 1/5th dose intradermal jet injector (ID-JI-0.1). Vaccination with the JI was less painful (87% no pain) than vaccination with a NS (60% no pain), but caused more transient erythema (JI 85%, NS 24%) and swelling (JI 50%, NS 5%). Intradermal vaccination caused less vaccination site soreness (ID 16%, IM 52%). At baseline all subjects had seroprotective antibody concentrations. After 28 days, GMC were slightly lower in the ID-JI-0.1 group than in the reference group (IM-NS-0.5). The differences were not statistically significant, but the stringent non-inferiority criterion (i.e. a difference of 1 serum dilution in the microneutralization assay) was not met. After one year, differences in GMC were no longer apparent. In contrast, intramuscular vaccination with a fractional dose administered with a needle (IM-NS-0.1) was statistically inferior to full-dose intramuscular vaccination. This shows that intradermal but not intramuscular delivery of fractional-dose IPV may be sufficient for routine polio vaccination.
authors.affiliation: Leiden University Medical Center (LUMC), Department of Infectious Diseases, Leiden, The Netherlands. d.soonawala@lumc.nl
authors.forename: Darius
authors.initials: D
authors.lastname: Soonawala
authors.forename: Pauline
authors.initials: P
authors.lastname: Verdijk
authors.forename: Alienke J
authors.initials: AJ
authors.lastname: Wijmenga-Monsuur
authors.forename: Claire J
authors.initials: CJ
authors.lastname: Boog
authors.forename: Patrick
authors.initials: P
authors.lastname: Koedam
authors.forename: Leo G
authors.initials: LG
authors.lastname: Visser
authors.forename: Nynke Y
authors.initials: NY
authors.lastname: Rots
mesh_terms: D000328:Adult; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D000917:Antibody Formation; D005260:Female; D006801:Humans; D007117:Immunization, Secondary; D007271:Injections, Intradermal; D007273:Injections, Intramuscular; D007277:Injections, Jet; D008297:Male; D009426:Netherlands; D011051:Poliomyelitis / Q000517:prevention & control*; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage* / Q000009:adverse effects; D014611:Vaccination / Q000295:instrumentation* / Q000379:methods; D055815:Young Adult
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D011054:Poliovirus Vaccine, Inactivated
keywords: Intradermal; Jet injector; Needle-free; Polio; Vaccination