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

• Published in: The Journal of infectious diseases Vol. 201; no. 9; pp. 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: Journal Article
• Language: English
• Published: United States The University of Chicago Press 01.05.2010; University of Chicago Press
• 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; Cuba
• ISSN: 0022-1899; 1537-6613; 1537-6613
• DOI: 10.1086/651611

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). Trial Registration. Controlled-trials.com identifier: ISRCTN19673867.