Randomized Controlled Clinical Trial of Fractional Doses of Inactivated Poliovirus Vaccine Administered Intradermally by Needle-Free Device in Cuba

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...

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Bibliographic Details
Published in:The Journal of infectious diseases 2010-05, Vol.201 (9), p.1344-1352
Main Authors: Resik, Sonia, Tejeda, Alina, Mas Lago, Pedro, Diaz, Manuel, Carmenates, Ania, Sarmiento, Luis, Alemañi, Nilda, Galindo, Belkis, Burton, Anthony, Friede, Martin, Landaverde, Mauricio, Sutter, Roland W.
Format: Article
Language:English
Subjects:
Antibodies
Cuba
Dosage
Dose-Response Relationship, Immunologic
Drug Administration Schedule
Experimentation
Female
Health care administration
Humans
Immune response
Inactivated poliovirus vaccine
Infant
Injections, Intramuscular
Injections, Jet
Male
Polio
Poliomyelitis
Poliomyelitis - immunology
Poliomyelitis - prevention & control
Poliovirus
Poliovirus Vaccine, Inactivated - administration & dosage
Poliovirus Vaccine, Inactivated - immunology
Vaccination
VIRUSES
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Summary: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
ISSN:0022-1899
1537-6613
DOI:10.1086/651611