Inactivated Poliovirus Vaccine (IPV) With or Without E.Coli Double Mutant Heat-Labile Toxin (dmLT) Challenge Study in Healthy Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

87

Participants

Timeline

Start Date

January 22, 2020

Primary Completion Date

February 1, 2021

Study Completion Date

February 1, 2021

Conditions
Polio
Interventions
BIOLOGICAL

Inactivated Poliomyelitis Vaccine (IPV)

"IMOVAX® Polio is a highly purified, inactivated poliovirus vaccine. Each 0.5 mL dose contains:~* Type 1 (Mahoney) 40 D-antigen units~* Type 2 (MEF1) 8 D-antigen units~* Type 3 (Saukett) 32 D-antigen units"

BIOLOGICAL

E.coli Double Mutant Heat-Labile Toxin (dmLT) (adjuvant)

"LT (R192G/L211A), or dmLT, is a protein toxoid derived from wild-type enterotoxigenic Escherichia coli (ETEC) labile toxin (LT). The LT toxin has been shown to have inherent mucosal adjuvant properties for co-administered antigens and thus has potential as a mucosal adjuvant for different co-administered vaccines. LT has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites, which are critical for activation of the secreted toxin molecules."

BIOLOGICAL

Bivalent Oral Polio Vaccine (bOPV)

"Polio Sabin™ One and Three (oral) is a bivalent, live attenuated poliomyelitis virus vaccine of the Sabin strains Type 1 (LSc, 2ab) and Type 3 (Leon 12a, 1b), propagated in MRC5 human diploid cells.~Each dose (0.1 mL) contains not less than 10⁶ 50% cell culture infectious dose (CCID₅₀) of Type 1 and 10⁵·⁸ CCID₅₀ of Type 3."

Trial Locations (1)

Unknown

University of Antwerpen, Antwerp

All Listed Sponsors
lead

PATH

OTHER

NCT04232943 - Inactivated Poliovirus Vaccine (IPV) With or Without E.Coli Double Mutant Heat-Labile Toxin (dmLT) Challenge Study in Healthy Adults | Biotech Hunter | Biotech Hunter