
Luis Sarmiento-Pérez
Assistant researcher

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