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NCT03028441 · ClinicalTrials.gov registry record · Phase 1
Phase I Trial of Measles Vectored Chikungungya Vaccine
A Phase 1 study of Chikungunya Virus Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 180
- Enrollment target
- 3
- Study locations
NCT03028441 is a Phase 1 study of Chikungunya Virus Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 180 participants, below the 413-participant average among 4 other Chikungunya Virus Infection trials with a reported enrollment target (56% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT03028441, a Phase 1 study of Chikungunya Virus Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 180 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study is a randomized, double-blinded, Phase 1, placebo- controlled, and dose comparison trial to evaluate the safety, immunogenicity and schedule of MV-CHIK. Two dosage levels and 3 immunization schedules will be evaluated. This study will enroll up to 180 healthy subjects aged 18 to 45 years.Study duration is approximately 22 months. Subject participation duration is approximately 8-13 months. The primary objectives are to evaluate the safety and tolerability of 5 x 10\^4 TCID50 and 5 x 10\^5 TCID50 MV-CHIK and placebo following two consecutive intramuscular injections and to assess the CHIKV serum plaque reduction neutralization test (PRNT50) antibody responses to 5 x 10\^4 TCID50, 5 x 10\^5 TCID50 of MV-CHIK or placebo on day 29 following the first dose.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL VRC-CHKVLP059-00-VP
Study Locations (3)
Georgia
- Emory Children's Center - Pediatric Infectious Diseases - Atlanta
Iowa
- University of Iowa - Vaccine Research and Education Unit - Iowa City
Texas
- Baylor College of Medicine - Molecular Virology and Microbiology - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2017-05-30 |
| Est. Completion | 2019-01-17 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03028441
The ClinicalTrials.gov registry entry for NCT03028441 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 413-participant average among 4 other Chikungunya Virus Infection trials with a reported enrollment target (56% lower). 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 Chikungunya Virus Infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03028441 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Georgia, Iowa, Texas.
Frequently Asked Questions
What is clinical trial NCT03028441 about?
NCT03028441 is a clinical study titled "Phase I Trial of Measles Vectored Chikungungya Vaccine". This study is a randomized, double-blinded, Phase 1, placebo- controlled, and dose comparison trial to evaluate the safety, immunogenicity and schedule of MV-CHIK. Two dosage levels and 3 immunization schedules will be evaluated. This study will enroll up to 180 healthy subjects aged 18 to 45 years....
What is the current status of trial NCT03028441?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2017-05-30. Estimated completion is 2019-01-17.
What conditions does trial NCT03028441 study?
This clinical trial studies the following conditions: Chikungunya Virus Infection.
What interventions are being tested in trial NCT03028441?
The interventions under investigation include: Placebo (OTHER), VRC-CHKVLP059-00-VP (BIOLOGICAL).
Who is sponsoring clinical trial NCT03028441?
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 NCT03028441 being conducted?
This trial has 3 study locations across Georgia, Iowa, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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