InvaplexAR-Detox and DmLT Adjuvant in the Netherlands and Zambia

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).

Conditions

• Shigellosis
• Bacillary 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.

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia

  collaborator OTHER

• PATH

  collaborator OTHER

• Walter Reed Army Institute of Research (WRAIR)

  collaborator FED

• Göteborg University

  collaborator OTHER

• European Vaccine Initiative

  collaborator OTHER

• European and Developing Countries Clinical Trials Partnership (EDCTP)

  collaborator OTHER_GOV

• Leiden University Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-10-10

Primary Completion

2025-05-31

Completion

2025-05-31

FDA Drug

Yes

Countries

• Netherlands

Study Locations