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).

Timeline

Start

2024-10-10

Primary completion

2025-05

Completion

2025-05

Publications

• Roozen GVT, Sukwa N, Chirwa M, White JA, Estrada M, Maier N, Turbyfill KR, Laird RM, Suvarnapunya AE, Sayeh A, D'Alessio F, Marion C, Pattacini L, Hoogerwerf MA, Murugan R, Terrinoni M, Holmgren JR, Sirima SB, Houard S, Simuyandi M, Roestenberg M. Safety, Tolerability, and Immunogenicity of the InvaplexAR-DetoxShigella Vaccine Co-Administered with the dmLT Adjuvant in Dutch and Zambian Adults: Study Protocol for a Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase Ia/b Clinical Trial. Vaccines (Basel). 2025 Jan 8;13(1):48. doi: 10.3390/vaccines13010048.

Drugs

Indications