Safety and immunogenicity of inactivated poliovirus vaccine based on Sabin strains with and without aluminum hydroxide: a phase I trial in healthy adults

Vaccine. 2013 Nov 12;31(47):5531-6. doi: 10.1016/j.vaccine.2013.09.021. Epub 2013 Sep 21.


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.

Keywords: Adjuvant; Aluminum hydroxide; D-antigen units; DU; IPV; Immunogenicity; Inactivated poliovirus vaccine; Phase I trial; Sabin strains; Safety; cIPV; conventional IPV; inactivated poliovirus vaccine.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / administration & dosage*
  • Adolescent
  • Adult
  • Aluminum Hydroxide / administration & dosage*
  • Antibodies, Neutralizing / blood
  • Antibodies, Viral / blood
  • Double-Blind Method
  • Healthy Volunteers
  • Humans
  • Injections, Intramuscular
  • Male
  • Middle Aged
  • Poliomyelitis / prevention & control*
  • Poliovirus Vaccine, Inactivated / administration & dosage
  • Poliovirus Vaccine, Inactivated / adverse effects*
  • Poliovirus Vaccine, Inactivated / immunology*
  • Young Adult


  • Adjuvants, Immunologic
  • Antibodies, Neutralizing
  • Antibodies, Viral
  • Poliovirus Vaccine, Inactivated
  • Aluminum Hydroxide

Associated data