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

Resik, Sonia ; Tejeda, Alina ; Lago, Pedro Mas ; Diaz, Manuel ; Carmenates, Ania ; Sarmiento, Luis LU ; Alemañi, Nilda ; Galindo, Belkis ; Burton, Anthony and Friede, Martin , et al. (2010) In The Journal of infectious diseases 201(9). p.52-1344
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%,... (More)

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).

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keywords
Cuba, Dose-Response Relationship, Immunologic, Drug Administration Schedule, Female, Humans, Infant, Injections, Intramuscular, Injections, Jet, Male, Poliomyelitis/immunology, Poliovirus Vaccine, Inactivated/administration & dosage
in
The Journal of infectious diseases
volume
201
issue
9
pages
9 pages
publisher
Oxford University Press
external identifiers
  • pmid:20350164
ISSN
1537-6613
DOI
10.1086/651611
language
English
LU publication?
no
id
bb09384e-befc-4ebc-999a-6165fb88767a
date added to LUP
2019-07-08 14:42:19
date last changed
2019-10-08 04:01:03
@article{bb09384e-befc-4ebc-999a-6165fb88767a,
  abstract     = {<p>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.</p><p>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.</p><p>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 &lt; .001). The median titers of each poliovirus serotype were significantly lower in the intradermal arm than in the intramuscular arm (P &lt; .001). Only minor local adverse effects and no moderate or serious adverse events were reported.</p><p>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).</p>},
  author       = {Resik, Sonia and Tejeda, Alina and Lago, Pedro Mas and Diaz, Manuel and Carmenates, Ania and Sarmiento, Luis and Alemañi, Nilda and Galindo, Belkis and Burton, Anthony and Friede, Martin and Landaverde, Mauricio and Sutter, Roland W},
  issn         = {1537-6613},
  language     = {eng},
  month        = {05},
  number       = {9},
  pages        = {52--1344},
  publisher    = {Oxford University Press},
  series       = {The Journal of infectious diseases},
  title        = {Randomized controlled clinical trial of fractional doses of inactivated poliovirus vaccine administered intradermally by needle-free device in Cuba},
  url          = {http://dx.doi.org/10.1086/651611},
  doi          = {10.1086/651611},
  volume       = {201},
  year         = {2010},
}