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Luis Sarmiento-Pérez

Assistant researcher

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

Author

  • 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

Summary, in English

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).

Publishing year

2010-05-01

Language

English

Pages

52-1344

Publication/Series

The Journal of infectious diseases

Volume

201

Issue

9

Document type

Journal article

Publisher

Oxford University Press

Topic

  • 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

Status

Published

ISBN/ISSN/Other

  • ISSN: 1537-6613