Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02337855 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel® With or Without GLA-AF for Intestinal Schistosomiasis in Healthy Adults
A Phase 1 study of Schistosomiasis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT02337855 is a Phase 1 study of Schistosomiasis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 72 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02337855, a Phase 1 study of Schistosomiasis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase I, first-in-human study of a vaccine against S. mansoni infection.The study will recruit 72 healthy adult males and non-pregnant females from a single clinical center to test two formulations of Sm-TSP-2 vaccine (using the Alhydrogel® only, and using Alhydrogel® plus GLA-AF), each at 3 different doses: 10ug, 30ug, and 100ug. The primary objective is to assess the safety and reactogenicity of ascending doses of Sm-TSP-2/Alhydrogel® (10ug, 30ug, or 100ug) with or without GLA-AF vaccine given as three doses administered on Days 1, 57, and 113.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Sm-TSP-2/Alhydrogel
- BIOLOGICAL Sm-TSP-2/Alhydrogel/GLA-AF
Study Locations (1)
Texas
- Baylor College of Medicine - Molecular Virology and Microbiology - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2015-02-04 |
| Est. Completion | 2017-01-27 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02337855
The ClinicalTrials.gov registry entry for NCT02337855 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Schistosomiasis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02337855 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT02337855 about?
NCT02337855 is a clinical study titled "A Phase I Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel® With or Without GLA-AF for Intestinal Schistosomiasis in Healthy Adults". This is a Phase I, first-in-human study of a vaccine against S. mansoni infection.The study will recruit 72 healthy adult males and non-pregnant females from a single clinical center to test two formulations of Sm-TSP-2 vaccine (using the Alhydrogel® only, and using Alhydrogel® plus GLA-AF), each at...
What is the current status of trial NCT02337855?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2015-02-04. Estimated completion is 2017-01-27.
What conditions does trial NCT02337855 study?
This clinical trial studies the following conditions: Schistosomiasis.
What interventions are being tested in trial NCT02337855?
The interventions under investigation include: Placebo (OTHER), Sm-TSP-2/Alhydrogel (BIOLOGICAL), Sm-TSP-2/Alhydrogel/GLA-AF (BIOLOGICAL).
Who is sponsoring clinical trial NCT02337855?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02337855 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.