Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05961059
PHASE1

InvaplexAR-Detox and DmLT Adjuvant in the Netherlands and Zambia

Sponsor: Leiden University Medical Center

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test a new Shigella vaccine (InvaplexAR-DETOX) in combination with a new adjuvant (dmLT) in healthy participants. The main questions it aims to answer are: * Is the new Shigella vaccine (with and without the new adjuvant) safe and well tolerated? * How wel does the new Shigella vaccine stimulate the immune system in combination with the new adjuvant, and without the new adjuvant? Participants will receive three vaccinations at 28-day intervals. Researchers will compare the results of participants vaccinated with the vaccine in combination with the adjuvant to the results of participants vaccinated with the vaccine only and to the results of participants vaccinated with a placebo (fake vaccine).

Official title: Phase Ia/b Double-blind, Placebo-controlled, Dose Escalating Safety Study of Detoxified Shigella Flexneri 2a Artificial Invasin Complex (InvaplexAR-Detox) Vaccine Formulated with and Without DmLT Adjuvant Given Intramuscularly to Healthy Adults in the Netherlands and Zambia

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

85

Start Date

2024-10-10

Completion Date

2025-05

Last Updated

2024-11-07

Healthy Volunteers

Yes

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.

Locations (1)

Leiden University Medical Center

Leiden, Netherlands