Phase 1 Novel Live Attenuated Serotype 2 Oral Polio Vaccine Study in Inactivated Polio Vaccine (IPV) Primed Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 16, 2017

Primary Completion Date

September 30, 2017

Study Completion Date

October 27, 2017

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."

Trial Locations (1)

2610

university of Antwerp - centre for the evaluation of vaccination, Wilrijk

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

NCT03430349 - Phase 1 Novel Live Attenuated Serotype 2 Oral Polio Vaccine Study in Inactivated Polio Vaccine (IPV) Primed Adults | Biotech Hunter | Biotech Hunter