Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03869333 · ClinicalTrials.gov registry record · Phase 1
Dose Escalating Study of Intramuscular Invaplex[AR-DETOX]
A Phase 1 study of Diarrhea, sponsored by PATH.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT03869333: Completed Phase 1 study of Diarrhea, sponsored by PATH.
NCT03869333 is a Phase 1 study of Diarrhea that has completed, run by PATH. The registered enrollment target is 58 participants, below the 155-participant average among 24 other Diarrhea trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03869333, a Phase 1 study of Diarrhea, has completed, sponsored by PATH.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study Summary
The main purpose of this study is to evaluate the safety of a Shigella flexneri 2a detoxified artificial invasin complex (Invaplex\[AR-Detox\]) vaccine candidate administered by intramuscular immunization.
Primary Outcome
All adverse events (AEs) were assessed for severity by the investigator according to the following scale: Grade 1 (Mild): Does not interfere with routine activities, minimal level of discomfort; Grade 2 (Moderate): Interferes with routine activities, moderate level of discomfort; Grade 3 (Severe): Unable to perform routine activities, significant level of discomfort; Grade 4 (Potentially life-threatening): Hospitalization or ER visit for potentially life-threatening event. An AE was conside
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Invaplex[AR-DETOX]
Study Locations (1)
Maryland
- Walter Reed Army Institute of Research Clinical Trials Center (WRAIR CTC) - Silver Spring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2019-03-18 |
| Est. Completion | 2020-06-12 |
| Phase | Phase 1 |
What the finished NCT03869333 record still lists
NCT03869333 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 155-participant average among 24 other Diarrhea trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Diarrhea appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03869333 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03869333 about?
NCT03869333 is a clinical study titled "Dose Escalating Study of Intramuscular Invaplex[AR-DETOX]". The main purpose of this study is to evaluate the safety of a Shigella flexneri 2a detoxified artificial invasin complex (Invaplex\[AR-Detox\]) vaccine candidate administered by intramuscular immunization.
What is the current status of trial NCT03869333?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2019-03-18. Estimated completion is 2020-06-12.
What conditions does trial NCT03869333 study?
This clinical trial studies the following conditions: Diarrhea.
What interventions are being tested in trial NCT03869333?
The interventions under investigation include: Placebo (OTHER), Invaplex[AR-DETOX] (BIOLOGICAL).
Who is sponsoring clinical trial NCT03869333?
This trial is sponsored by PATH, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03869333 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diarrhea
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03869333's enrollment target sits among peer trials
58 12th of 24 higher than 13 of 24 other Diarrhea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diarrhea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients
RECRUITING · Phase 1
-
First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults
RECRUITING · Phase 1
-
A Study of SER-155 to Treat Diarrhea in People on Immunotherapy
RECRUITING · Phase 1
-
Irinotecan and Celecoxib in Treating Patients With Unresectable or Metastatic Colorectal Cancer
COMPLETED · Phase 1
-
Invaplex 50 Vaccine Dose-Ranging
COMPLETED · Phase 1
-
GI Alpha-Gal Study
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03587844 · 58 participants · Phase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
- NCT03630991 · 58 participants · Phase 1
Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy
- NCT03949855 · 58 participants · Phase 2
Belimumab With Rituximab for Primary Membranous Nephropathy
- NCT04069273 · 58 participants · Phase 2
Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI