Randomized controlled clinical trial of fractional doses of inactivated poliovirus vaccine administered intradermally by needle-free device in Cuba

Research output: Contribution to journalArticle

Abstract

BACKGROUND: As part of an evaluation of strategies to make inactivated poliovirus vaccine (IPV) affordable for developing countries, we conducted a clinical trial of fractional doses of IPV in Cuba.

METHODS: We compared the immunogenicity and reactogenicity of fractional-dose IPV (0.1 mL, or 1/5 of a full dose) given intradermally using a needle-free jet injector device compared with full doses given intramuscularly. Subjects were randomized at birth to receive IPV at 6, 10, and 14 weeks.

RESULTS: A total of 471 subjects were randomized to the 2 study groups, and 364 subjects fulfilled the study requirements. No significant differences at baseline were detected. Thirty days after completing the 3-dose schedule of IPV, 52.9%, 85.0%, and 69.0% of subjects in the fractional-dose IPV arm seroconverted for poliovirus types 1, 2, and 3, respectively, whereas 89.3%, 95.5%, and 98.9% of subjects in the full-dose IPV arm seroconverted for poliovirus types 1, 2, and 3, respectively (all comparisons, P < .001). The median titers of each poliovirus serotype were significantly lower in the intradermal arm than in the intramuscular arm (P < .001). Only minor local adverse effects and no moderate or serious adverse events were reported.

CONCLUSIONS: This large-scale evaluation demonstrates the feasibility of fractional doses of IPV given intradermally as an antigen-sparing strategy but also shows that IPV given to infants at 6, 10, and 14 weeks of age results in suboptimal immunogenicity (especially for the fractional-dose arm).

Details

Authors
  • Sonia Resik
  • Alina Tejeda
  • Pedro Mas Lago
  • Manuel Diaz
  • Ania Carmenates
  • Luis Sarmiento
  • Nilda Alemañi
  • Belkis Galindo
  • Anthony Burton
  • Martin Friede
  • Mauricio Landaverde
  • Roland W Sutter
External organisations
  • Pedro Kouri Tropical Medicine Institute (IPK)
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Clinical Medicine

Keywords

  • Cuba, Dose-Response Relationship, Immunologic, Drug Administration Schedule, Female, Humans, Infant, Injections, Intramuscular, Injections, Jet, Male, Poliomyelitis/immunology, Poliovirus Vaccine, Inactivated/administration & dosage
Original languageEnglish
Pages (from-to)1344-52
Number of pages9
JournalThe Journal of infectious diseases
Volume201
Issue number9
Publication statusPublished - 2010 May 1
Publication categoryResearch
Peer-reviewedYes
Externally publishedYes