InvaplexAR-Detox and DmLT Adjuvant in the Netherlands and Zambia

PHASE1RecruitingINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

October 10, 2024

Primary Completion Date

May 31, 2025

Study Completion Date

May 31, 2025

Conditions
ShigellosisBacillary Dysentery
Interventions
BIOLOGICAL

2.5 μg InvaplexAR-Detox

2.5 μg intramuscular dose of Sfl2a InvaplexAR-Detox.

BIOLOGICAL

10 μg InvaplexAR-Detox

10 μg intramuscular dose of Sfl2a InvaplexAR-Detox.

BIOLOGICAL

0.1 μg of dmLT

0.1 μg intramuscular dose of double mutant (LT R192G/L211A) enterotoxigenic Escherichia coli heat labile toxin (dmLT).

BIOLOGICAL

Placebo

Placebo vaccination with commercially available saline solution.

Trial Locations (1)

2333 ZA

RECRUITING

Leiden University Medical Center, Leiden

All Listed Sponsors
collaborator

Centre for Infectious Disease Research in Zambia

OTHER

collaborator

PATH

OTHER

collaborator

Walter Reed Army Institute of Research (WRAIR)

FED

collaborator

Göteborg University

OTHER

collaborator

European Vaccine Initiative

OTHER

collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

lead

Leiden University Medical Center

OTHER