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Phase I Trial of Measles Vectored Chikungungya Vaccine
NCT03028441 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 180 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 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03028441 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Georgia, Iowa, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03028441?
The interventions under investigation include: Placebo (OTHER), VRC-CHKVLP059-00-VP (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03028441?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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