Reactogenicity and immunogenicity of inactivated poliovirus vaccine produced from Sabin strains: A phase I Trial in healthy adults in Cuba

• Published in: Vaccine Vol. 32; no. 42; pp. 5399 - 5404
• Main Authors: Resik, Sonia, Tejeda, Alina, Fonseca, Magilé, Alemañi, Nilda, Diaz, Manuel, Martinez, Yenisleidys, Garcia, Gloria, Okayasu, Hiromasa, Burton, Anthony, Bakker, Wilfried A.M, Verdijk, Pauline, Sutter, Roland W
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 22.09.2014; Elsevier; Elsevier Limited
• Subjects: Adjuvant; Adjuvants, Immunologic - administration & dosage; Adult; Allergy and Immunology; Aluminum; Aluminum hydroxide; Antibodies, Neutralizing - blood; Antibodies, Viral - blood; Antigens; Applied microbiology; Biological and medical sciences; Blood & organ donations; Body temperature; Cuba; Developing countries; Ethics; Fundamental and applied biological sciences. Psychology; Humans; Immunogenicity; Inactivated poliovirus vaccine; Laboratories; LDCs; Male; Microbiology; Miscellaneous; Neutralization; Phase I trial; Poliomyelitis; Poliomyelitis - prevention & control; Poliovirus Vaccine, Inactivated - adverse effects; Poliovirus Vaccine, Inactivated - immunology; Poliovirus Vaccine, Inactivated - therapeutic use; Poliovirus Vaccine, Oral - adverse effects; Poliovirus Vaccine, Oral - immunology; Poliovirus Vaccine, Oral - therapeutic use; Sabin strains; Safety; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Virology; Young Adult; Central America; Cuba; America; West Indies; Nigeria; Pakistan; ASW, Caribbean Sea, Greater Antilles, Cuba; Sabin strains; Inactivated poliovirus vaccine; Immunogenicity; Aluminum hydroxide; Phase I trial; Adjuvant; Safety; Picornaviridae; Vaccine strain; Toxicity; Tropical zone; Enterovirus; Poliovirus; Virus; Immunological adjuvant; Inactivated strain
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2014.07.109

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. Discussion 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.