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


METHODS
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.


CONCLUSIONS
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.
Institute for Translational Vaccinology (Intravacc), P.O. Box 450, 3720 AL Bilthoven, The Netherlands. Electronic address: pauline.verdijk@intravacc.nl.
Pauline
P
Verdijk
Nynke Y
NY
Rots
Monique G C T
MG
van Oijen
M Steven
MS
Oberste
Claire J
CJ
Boog
Hiromasa
H
Okayasu
Roland W
RW
Sutter
Wilfried A M
WA
Bakker
D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D000536:Aluminum Hydroxide / Q000008:administration & dosage*; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D004311:Double-Blind Method; D064368:Healthy Volunteers; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D011051:Poliomyelitis / Q000517:prevention & control*; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D055815:Young Adult
D000276:Adjuvants, Immunologic; D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D011054:Poliovirus Vaccine, Inactivated; D000536:Aluminum Hydroxide
Adjuvant; Aluminum hydroxide; D-antigen units; DU; IPV; Immunogenicity; Inactivated poliovirus vaccine; Phase I trial; Sabin strains; Safety; cIPV; conventional IPV; inactivated poliovirus vaccine