title: Reactogenicity and immunogenicity of inactivated poliovirus vaccine produced from Sabin strains: a phase I Trial in healthy adults in Cuba.
abstract: BACKGROUND
  To ensure that developing countries have the option to produce inactivated poliovirus vaccine (IPV), the Global Polio Eradication Initiative has promoted the development of an IPV using Sabin poliovirus strains (Sabin IPV). This trial assessed the reactogenicity and immunogenicity of Sabin IPV and adjuvanted Sabin IPV in healthy adults in Cuba.
  
  
  METHODS
  This is a randomized, controlled phase I trial, enrolling 60 healthy (previously vaccinated) male human volunteers, aged 19-23 years to receive one dose of either Sabin IPV (20:32:64 DU/dose), adjuvanted Sabin IPV (10:16:32 DU/dose), or conventional Salk IPV (40:8:32 DU/dose). The primary endpoint for reactogenicity relied on monitoring of adverse events. The secondary endpoint measured boosting immune responses (i.e. seroconversion or 4-fold rise) of poliovirus antibody, assessed by neutralization assays.
  
  
  RESULTS
  Sixty subjects fulfilled the study requirements. No serious adverse events reported were attributed to trial interventions during the 6-month follow-up period. Twenty-eight days after vaccination, boosting immune responses against poliovirus types 1-3 were between 90% and 100% in all vaccination groups. There was a more than 6-fold increase in median antibody titers between pre- and post-vaccination titers in all vaccination groups.
  
  
  CONCLUSIONS
  Both Sabin IPV and adjuvanted Sabin IPV were well tolerated and immunogenic against all poliovirus serotypes. This result suggests that the aluminum adjuvant may allow a 50% (or higher) dose reduction.
authors.affiliation: Institute Pedro Kouri, Havana, Cuba.
authors.forename: Sonia
authors.initials: S
authors.lastname: Resik
authors.affiliation: Provincial Health Office, Camagüey, Cuba.
authors.forename: Alina
authors.initials: A
authors.lastname: Tejeda
authors.affiliation: Institute Pedro Kouri, Havana, Cuba.
authors.forename: Magilé
authors.initials: M
authors.lastname: Fonseca
authors.affiliation: Provincial Health Office, Camagüey, Cuba.
authors.forename: Nilda
authors.initials: N
authors.lastname: Alemañi
authors.affiliation: Institute Pedro Kouri, Havana, Cuba.
authors.forename: Manuel
authors.initials: M
authors.lastname: Diaz
authors.affiliation: Institute Pedro Kouri, Havana, Cuba.
authors.forename: Yenisleidys
authors.initials: Y
authors.lastname: Martinez
authors.affiliation: Institute Pedro Kouri, Havana, Cuba.
authors.forename: Gloria
authors.initials: G
authors.lastname: Garcia
authors.affiliation: World Health Organization, Geneva, Switzerland. Electronic address: okayasuhi@who.int.
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Okayasu
authors.affiliation: World Health Organization, Geneva, Switzerland.
authors.forename: Anthony
authors.initials: A
authors.lastname: Burton
authors.affiliation: Intravacc, Bilthoven, The Netherlands.
authors.forename: Wilfried A M
authors.initials: WA
authors.lastname: Bakker
authors.affiliation: Intravacc, Bilthoven, The Netherlands.
authors.forename: Pauline
authors.initials: P
authors.lastname: Verdijk
authors.affiliation: World Health Organization, Geneva, Switzerland.
authors.forename: Roland W
authors.initials: RW
authors.lastname: Sutter
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000328:Adult; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D003462:Cuba; D006801:Humans; D008297:Male; D011051:Poliomyelitis / Q000517:prevention & control*; D011054:Poliovirus Vaccine, Inactivated / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use; D011055:Poliovirus Vaccine, Oral / Q000009:adverse effects / Q000276:immunology* / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D011054:Poliovirus Vaccine, Inactivated; D011055:Poliovirus Vaccine, Oral
keywords: Adjuvant; Aluminum hydroxide; Immunogenicity; Inactivated poliovirus vaccine; Phase I trial; Sabin strains; Safety