title: Comparison of the Immunogenicity of Various Booster Doses of Inactivated Polio Vaccine Delivered Intradermally Versus Intramuscularly to HIV-Infected Adults.
abstract: BACKGROUND
  Inactivated polio vaccine (IPV) is necessary for global polio eradication because oral polio vaccine can rarely cause poliomyelitis as it mutates and may fail to provide adequate immunity in immunocompromised populations. However, IPV is unaffordable for many developing countries. Intradermal IPV shows promise as a means to decrease the effective dose and cost of IPV, but prior studies, all using 20% of the standard dose used in intramuscular IPV, resulted in inferior antibody titers.
  
  
  METHODS
  We randomly assigned 231 adults with well-controlled human immunodeficiency virus infection at a ratio of 2:2:2:1 to receive 40% of the standard dose of IPV intradermally, 20% of the standard dose intradermally, the full standard dose intramuscularly, or 40% of the standard dose intramuscularly. Intradermal vaccination was done using the NanoPass MicronJet600 microneedle device.
  
  
  RESULTS
  Baseline immunity was 87%, 90%, and 66% against poliovirus serotypes 1, 2, and 3, respectively. After vaccination, antibody titers increased a median of 64-fold. Vaccine response to 40% of the standard dose administered intradermally was comparable to that of the standard dose of IPV administered intramuscularly and resulted in higher (although not significantly) antibody titers. Intradermal administration had higher a incidence of local side effects (redness and itching) but a similar incidence of systemic side effects and was preferred by study participants over intramuscular administration.
  
  
  CONCLUSIONS
  A 60% reduction in the standard IPV dose without reduction in antibody titers is possible through intradermal administration.
authors.affiliation: Department of Internal Medicine.
authors.forename: Stephanie B
authors.initials: SB
authors.lastname: Troy
authors.affiliation: Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Diana
authors.initials: D
authors.lastname: Kouiavskaia
authors.affiliation: Department of Internal Medicine.
authors.forename: Julia
authors.initials: J
authors.lastname: Siik
authors.affiliation: NanoPass Technologies, Nes Ziona, Israel.
authors.forename: Efrat
authors.initials: E
authors.lastname: Kochba
authors.affiliation: Graduate Program in Public Health, Eastern Virginia Medical School, Norfolk.
authors.forename: Hind
authors.initials: H
authors.lastname: Beydoun
authors.affiliation: Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Olga
authors.initials: O
authors.lastname: Mirochnitchenko
authors.affiliation: NanoPass Technologies, Nes Ziona, Israel.
authors.forename: Yotam
authors.initials: Y
authors.lastname: Levin
authors.affiliation: Department of Internal Medicine.
authors.forename: Nancy
authors.initials: N
authors.lastname: Khardori
authors.affiliation: Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Konstantin
authors.initials: K
authors.lastname: Chumakov
authors.affiliation: Department of Pediatrics, Stanford University School of Medicine, California.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Maldonado
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D005260:Female; D015658:HIV Infections / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods*; D007271:Injections, Intradermal; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D011051:Poliomyelitis / Q000276:immunology* / Q000517:prevention & control*; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000276:immunology*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D011054:Poliovirus Vaccine, Inactivated
keywords: HIV; fractional dose; inactivated polio vaccine; intradermal; polio; vaccine