A Phase 2 Study to Evaluate the Safety and Immunogenicity of Two Oral Poliovirus Vaccine Candidates

PHASE2CompletedINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

October 22, 2018

Primary Completion Date

January 31, 2019

Study Completion Date

May 8, 2019

Conditions
Poliomyelitis
Interventions
BIOLOGICAL

Novel OPV2 candidate 1

"Live-attenuated serotype-2 poliovirus derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells; candidate 1 (S2/cre5/S15domV/rec1/hifi3).~Modifications included the following:~* Changes to the viral nucleotide sequence in part of the 5'-untranslated region to improve the genetic stability of this major attenuating determinant of Sabin type-2 to avoid reversion by single nucleotide changes.~* Two modifications in the polymerase 3D to further improve stability of the attenuation and reduce frequency of recombination events~* Relocation of a key replication element from the 2C coding region to the 5'-untranslated region, to inhibit recombination."

BIOLOGICAL

Novel OPV2 candidate 2

"Live-attenuated serotype-2 poliovirus derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells; candidate 2 (S2/S15domV/CpG40).~Modifications included the following:~* Changes to the viral nucleotide sequence in part of the 5'-untranslated region to improve the genetic stability of this major attenuating determinant of Sabin type-2 to avoid reversion by single nucleotide changes.~* silent non-coding modifications engineered within the capsid (VP1-4) designed to reduce replicative fitness and, potentially, to improve stability of the attenuated phenotype while also reducing transmission."

BIOLOGICAL

Placebo

sugar syrup, propylene glycol (Sirupus simplex, Propylenglycolum, European Pharmacopoeia)

Trial Locations (2)

2610

Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Wilrijk

9000

CEVAC, Center for Vaccinology, Ghent University Hospital, Ghent

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

Centers for Disease Control and Prevention

FED

collaborator

PATH

OTHER

collaborator

Celerion

INDUSTRY

lead

Pierre Van Damme

OTHER

NCT04544787 - A Phase 2 Study to Evaluate the Safety and Immunogenicity of Two Oral Poliovirus Vaccine Candidates | Biotech Hunter | Biotech Hunter