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New treatment option for Shigellosis
Official title InvaplexAR-Detox and DmLT Adjuvant in the Netherlands and Zambia
ClinicalTrials.gov ID: NCT05961059
What this study is testing
What is 2.5 μg InvaplexAR-Detox?
2.5 μg InvaplexAR-Detox is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for shigellosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Healthy adult, male or female, aged 18 to 50 years (inclusive) at the time of inclusion (=vaccination).
- Provide written informed consent before initiation of any study procedures.
- Available to complete all study visits and procedures.
- Negative stool PCR test for Shigella.
- Women of childbearing potential: negative pregnancy test at screening and before each study vaccine administration. Women are considered not of...
See the full eligibility criteria
- Healthy adult, male or female, aged 18 to 50 years (inclusive) at the time of inclusion (=vaccination).
- Provide written informed consent before initiation of any study procedures.
- Available to complete all study visits and procedures.
- Negative stool PCR test for Shigella.
- 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...
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)
- progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable) 2. intrauterine device (IUD) 3. intrauterine hormone-releasing system (IUS) 4. bilateral tubal...
- Any history or evidence of clinically relevant chronic medical conditions (such as: psychiatric conditions, diabetes mellitus, hypertension [treated by medication], autoimmune disorders, immunodeficiencies...
- Current use of immunosuppressive medications (except for antihistamines and topical or inhalation corticosteroids).
- Women who are a) currently nursing or b) who are pregnant or planning to become pregnant during the study period plus 3 months beyond the last vaccine dose.
- Participation in research involving another investigational product (defined as receipt of an investigational product or exposure to an invasive investigational device) 30 days before the first vaccination or anytime...
- Positive blood test for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Clinically significant abnormalities on basic laboratory screening tests.
- Systemic antimicrobial treatment (i.e., topical treatments are not an exclusion criterion) within 1 week before the first vaccine dose (temporary exclusion).
- Known hypersensitivity to compounds in the vaccine or adjuvant or other known drug allergies that may increase the risk of adverse events.
- Regular use (weekly or more often) of antidiarrheal, anti-constipation, or antacid therapy.
- Abnormal stool pattern (fewer than 3 stools per week or more than 3 stools per day) on a regular basis; loose or liquid stools on other than an occasional basis.
- Personal or family history of inflammatory arthritis.
- Proven allergy to any substance in the InvaplexAR-Detox vaccine or dmLT or history of anaphylactic reaction to any other vaccine.
- Exclusionary skin disease history/findings that would confound assessment or prevent appropriate monitoring of local AEs, or possibly increase the risk of local AEs.
- Recent (\<3 months) history of gastroenteritis.
- Received previous licensed or experimental Shigella vaccine, dmLT or live Shigella challenge.
- Any severe medical condition that might place the participant at increased risk of adverse events according to the clinical judgment of the study clinicians in consultation with the PI.
- Any planned vaccination within 14 days before the first vaccine dose until the last in-clinic study visit, with the exception of SARS-CoV-2 vaccines or influenza vaccines.
The study team makes the final eligibility decision.
Where it's taking place
- Leiden, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leiden, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.