Actively Recruiting
InvaplexAR-Detox and DmLT Adjuvant in the Netherlands and Zambia
Led by Leiden University Medical Center · Updated on 2024-11-07
85
Participants Needed
1
Research Sites
29 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
C
Centre for Infectious Disease Research in Zambia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
InvaplexAR-Detox and DmLT Adjuvant in the Netherlands and Zambia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 50 years at time of vaccination
- Provide written informed consent before starting any study procedures
- Available to complete all study visits and procedures
- Negative stool PCR test for Shigella
- Women of childbearing potential must have negative pregnancy tests at screening and before each vaccination
- Women of childbearing potential must agree to use effective contraception from 4 weeks before first vaccination until 3 months after last vaccine dose
- Acceptable contraception methods include hormonal contraception, intrauterine devices or systems, bilateral tubal ligation, vasectomized partner, or sexual abstinence
You will not qualify if you...
- History or evidence of significant chronic medical conditions such as psychiatric disorders, diabetes, hypertension treated with medication, autoimmune disorders, immunodeficiencies, cardiovascular or renal disease, or inflammatory bowel disease
- Current use of immunosuppressive drugs except antihistamines and topical or inhaled corticosteroids
- Women who are pregnant, nursing, or planning pregnancy during the study and 3 months after last vaccine dose
- Participation in other investigational studies involving products or devices 30 days before or during this study
- Positive tests for hepatitis B surface antigen, hepatitis C virus, or HIV
- Significant abnormalities in basic lab screening tests
- Use of systemic antimicrobial treatment within 1 week before first vaccine dose
- Known allergies to vaccine or adjuvant components or other drug allergies increasing risk of adverse events
- Regular use of antidiarrheal, anti-constipation, or antacid medications
- Abnormal stool patterns with fewer than 3 stools per week or more than 3 stools per day regularly
- Personal or family history of inflammatory arthritis
- History of anaphylaxis to vaccines
- Skin diseases that interfere with assessment or monitoring of injection site
- Recent gastroenteritis within 3 months
- Previous receipt of licensed or experimental Shigella vaccine, dmLT, or live Shigella challenge
- Any severe medical condition increasing risk of adverse events per clinical judgment
- Planned vaccinations other than SARS-CoV-2 or influenza vaccines within 14 days before first dose until last safety visit
AI-Screening
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Trial Site Locations
Total: 1 location
1
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
Actively Recruiting
Research Team
M
Meta Roestenberg, MD, PhD
CONTACT
M
Maxim Bax, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
5
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