Journal
VACCINE
Volume 31, Issue 47, Pages 5531-5536Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2013.09.021
Keywords
Inactivated poliovirus vaccine; Sabin strains; Aluminum hydroxide; Adjuvant; Phase I trial; Safety; Immunogenicity
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Funding
- World Health Organization
- Bill and Melinda Gates Foundation
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Background: An inactivated poliovirus vaccine (IPV) based on attenuated poliovirus strains (Sabin-1, -2 and -3) was developed for technology transfer to manufacturers in low- and middle income countries in the context of the Global Polio Eradication Initiative. Method: Safety and immunogenicity of the Sabin-IPV was evaluated in a double-blind, randomized, controlled, phase I 'proof-of-concept' trial. Healthy male adults received a single intramuscular injection with Sabin-IPV, Sabin-IPV adjuvanted with aluminum hydroxide or conventional IPV. Virus-neutralizing titers against both Sabin and wild poliovirus strains were determined before and 28 days after vaccination. Results: No vaccine-related serious adverse events were observed, and all local and systemic reactions were mild or moderate and transient. In all subjects, an increase in antibody titer for all types of poliovirus (both Sabin and wild strains) was observed 28 days after vaccination. Conclusion: Sabin-IPV and Sabin-IPV adjuvanted with aluminum hydroxide administered as a booster dose were equally immunogenic and safe as conventional IPV. EudraCTnr: 2010-024581-22, NCT01708720. (C) 2013 Elsevier Ltd. All rights reserved.
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