Your browser has javascript turned off or blocked. This will lead to some parts of our website to not work properly or at all. Turn on javascript for best performance.

The browser you are using is not supported by this website. All versions of Internet Explorer are no longer supported, either by us or Microsoft (read more here: https://www.microsoft.com/en-us/microsoft-365/windows/end-of-ie-support).

Please use a modern browser to fully experience our website, such as the newest versions of Edge, Chrome, Firefox or Safari etc.

Default user image.

Luis Sarmiento-Pérez

Assistant researcher

Default user image.

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