InvaplexAR-Detox and DmLT Adjuvant in the Netherlands and Zambia
Trial Parameters
Brief 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).
Eligibility Criteria
Inclusion Criteria: 1. Healthy adult, male or female, aged 18 to 50 years (inclusive) at the time of inclusion (=vaccination). 2. Provide written informed consent before initiation of any study procedures. 3. Available to complete all study visits and procedures. 4. Negative stool PCR test for Shigella. 5. Women of childbearing potential: negative pregnancy test at screening and before each study vaccine administration. Women are considered not of childbearing potential if they are postmenopausal (no menses for 12 months without an alternative medical cause), or if they have no uterus or no ovaries. Women of childbearing potential must agree to use continuous adequate contraception to avoid pregnancy during the study, for at least 4 weeks before the first vaccination and for 3 months following the last vaccine dose. Adequate methods of contraception for this study include: 1\. hormonal contraception 1. combined (estrogen and progestogen containing) hormonal contraception associated wit