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NCT02231866 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Immunogenicity of the Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO), VRC-EBOADC069-00-VP, in Healthy Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 143
- Enrollment target
NCT02231866 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 143 participants.
The verdict
NCT02231866, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 143 participants
- Enrollment target
Study Summary
Background: \- Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is impossible for someone to get an Ebola infection from this vaccine. Objectives: \- To see if an Ebola vaccine is safe and to study immune responses to it. Eligibility: \- Healthy adults ages 18-65. Design: * Participants will be screened through a separate protocol. * Participants will receive the vaccine injection by needle and syringe into an upper arm muscle. - Participants will stay at the clinic for 3 hours after the injection. * About 2 days later, participants must speak with clinic staff about how they are doing. * Every day for 7 days after the injection, participants will record their temperature and symptoms and look at the injection site. They will get a thermometer and a ruler to measure any redness or swelling. They will report any side effects. * In the first 2 months in the study, participants will have at least 6 clinic visits and 1 phone call. They will have at least 3 other visits over the next 9 months. * At each visit, participants will be checked for health changes or problems since their last visit. They will be asked how they feel and if they have taken any medicine. Blood will be drawn at most visits. Urine samples may be collected.
Interventions
- BIOLOGICAL VRC-EBOADC069-00-VP
- BIOLOGICAL VRC-EBOADC076-00-VP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2014-08-27 |
| Est. Completion | 2017-04-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02231866
The ClinicalTrials.gov registry entry for NCT02231866 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 143 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 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which VRC-EBOADC069-00-VP is the first listed.
NCT02231866 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02231866 about?
NCT02231866 is a clinical study titled "Safety, Tolerability, and Immunogenicity of the Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO), VRC-EBOADC069-00-VP, in Healthy Adults". Background: \- Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is impossible for ...
What is the current status of trial NCT02231866?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 143 participants. The study started on 2014-08-27. Estimated completion is 2017-04-05.
What interventions are being tested in trial NCT02231866?
The interventions under investigation include: VRC-EBOADC069-00-VP (BIOLOGICAL), VRC-EBOADC076-00-VP (BIOLOGICAL).
Who is sponsoring clinical trial NCT02231866?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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