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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: Completed Phase 1 study of Schistosomiasis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 72 participants
Start Date 2015-02-04
Est. Completion 2017-01-27
Phase Phase 1

What the finished NCT02337855 record still lists

NCT02337855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).

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 a single indexed study location in 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.

How this trial's enrollment target compares

Where NCT02337855's enrollment target sits among peer trials

72 736th of 2000 higher than 1,254 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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

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Source: ClinicalTrials.gov NCT02337855, the US trial registry maintained by the National Library of Medicine. NCT02337855 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.