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NCT03527173 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy, Safety and Immunogenicity of a Vaccine Designed to Protect Against Infection With Shigella Sonnei in Healthy Adults
A Phase 2 study of Dysentery, Bacillary, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
- 1
- Study location
NCT03527173 is a Phase 2 study of Dysentery, Bacillary that has completed, run by GlaxoSmithKline. The registered enrollment target is 71 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03527173, a Phase 2 study of Dysentery, Bacillary, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the GSK3536852A vaccine, which was designed to protect against shigellosis caused by Shigella sonnei (S. sonnei) and is using the new Generalized Modules for Membrane Antigens (GMMA) platform technology developed by GlaxoSmithKline (GSK) Vaccines Institute for Global Health (GVGH). The study vaccine could be the stepping stone for the development of a multivalent broadly protective Shigella vaccine for vaccination of impoverished communities where shigellosis is endemic. However, a standalone monovalent vaccine against S. sonnei could be used to protect travelers against diarrheal shigellosis, as the vast majority of travelers' shigellosis is caused by S. sonnei, and even to protect infants in endemic regions where shigellosis is primarily caused by S. sonnei. The GSK3536852A vaccine has been tested in two Phase I dose escalation studies in Europe to assess its safety and immunogenicity via three routes of administration: intramuscular (IM), intranasal (IN) and intradermal (ID). The results from the first study (dose escalation with IM vaccination) have shown that the vaccine has an acceptable safety profile and is well-tolerated up to a dose of 100 micrograms (µg). The results from the second study (dose escalation with ID, IN and IM vaccination) showed that GSK3536852A vaccine is well-tolerated also when administered by the ID and IN routes of vaccination. However, immunogenicity data have shown that GSK3536852A vaccine administered by the ID and IN routes is not as immunogenic as GSK3536852A vaccine administered by the IM route. Therefore, it has been decided to proceed with the clinical development program of this vaccine only using the IM vaccination route. In terms of dosage, the regimen tested in Phase I studies (three doses given one month apart) did not show any significant benefit from the third dose in terms of immunogenicity, therefore a two dose schedule was selected f
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL S.sonnei vaccine
- BIOLOGICAL S. sonnei 53G challenge strain
Study Locations (1)
Ohio
- GSK Investigational Site - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2018-08-29 |
| Est. Completion | 2019-11-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03527173
The ClinicalTrials.gov registry entry for NCT03527173 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Dysentery, Bacillary appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03527173 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT03527173 about?
NCT03527173 is a clinical study titled "A Study to Evaluate the Efficacy, Safety and Immunogenicity of a Vaccine Designed to Protect Against Infection With Shigella Sonnei in Healthy Adults". The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the GSK3536852A vaccine, which was designed to protect against shigellosis caused by Shigella sonnei (S. sonnei) and is using the new Generalized Modules for Membrane Antigens (GMMA) platform technology developed by ...
What is the current status of trial NCT03527173?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2018-08-29. Estimated completion is 2019-11-11.
What conditions does trial NCT03527173 study?
This clinical trial studies the following conditions: Dysentery, Bacillary.
What interventions are being tested in trial NCT03527173?
The interventions under investigation include: Placebo (DRUG), S.sonnei vaccine (BIOLOGICAL), S. sonnei 53G challenge strain (BIOLOGICAL).
Who is sponsoring clinical trial NCT03527173?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03527173 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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