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NCT01489358 · ClinicalTrials.gov registry record · Phase 1
Chikungunya Virus Vaccine Trial in Healthy Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT01489358: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01489358 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01489358, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
Background: \- Chikungunya virus (CHIKV) is transmitted by mosquitoes. It can cause fever, headache, muscle pain, fatigue, and joint pain. The disease usually does not cause death. But the joint pain, which may be directly related to the infecting virus, may be severe and last for several months. CHIKV outbreaks are most common in Africa, India, and Asia. A new experimental vaccine for CHIKV has been developed, and researchers are testing it in healthy adults. Participants cannot develop CHIKV from this vaccine. Objectives: \- To test the safety and effectiveness of a Chikungunya virus vaccine. Eligibility: \- Healthy individuals between 18 and 50 years of age. Design: * This study, including vaccine doses and followup tests, will last about 44 weeks. Participants will have three vaccination visits, six followup clinic visits, and three telephone contacts during this study. Vaccination visits will take about 4 hours. Most other clinic visits will usually take 2 hours. The telephone contacts will take about 15 minutes. * Participants will be screened with a physical exam and medical history. Blood samples will also be collected. * Participants will be assigned to one of three dose groups. Information about doses will be provided before the start of the vaccinations. * Vaccine injections will be given at the start of the study, at 4 weeks, and at 20 weeks. Participants will be asked to keep an eye on the injection site for 7 days and to notify researchers if there are any side effects. * Participants will be monitored throughout the study with blood samples and clinic visits.
Primary Outcome
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.
Interventions
- BIOLOGICAL VRC-CHKVLP059-00-VP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
What the finished NCT01489358 record still lists
NCT01489358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which VRC-CHKVLP059-00-VP is the first listed.
NCT01489358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01489358 about?
NCT01489358 is a clinical study titled "Chikungunya Virus Vaccine Trial in Healthy Adults". Background: \- Chikungunya virus (CHIKV) is transmitted by mosquitoes. It can cause fever, headache, muscle pain, fatigue, and joint pain. The disease usually does not cause death. But the joint pain, which may be directly related to the infecting virus, may be severe and last for several months. C...
What is the current status of trial NCT01489358?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2011-12. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01489358?
The interventions under investigation include: VRC-CHKVLP059-00-VP (BIOLOGICAL).
Who is sponsoring clinical trial NCT01489358?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01489358's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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