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NCT02840487 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA085-00-VP, in Healthy Adults
A Phase 1 study of Prevention of Zika Infection and Zika-Specific Immune Response, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 3
- Study locations
NCT02840487 is a Phase 1 study of Prevention of Zika Infection and Zika-Specific Immune Response that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 80 participants. The trial reports 3 study locations across 2 states.
The verdict
NCT02840487, a Phase 1 study of Prevention of Zika Infection and Zika-Specific Immune Response, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 3
- Study locations
Study Summary
Background: The Zika virus is passed to humans by infected mosquitos. It usually causes fever, rash, joint pain, and red eyes. Recently, some cases of microcephaly (abnormally small head) were reported in babies born to mothers infected with the Zika virus. Rare cases of a severe nerve weakness called Guillain-Barr(SqrRoot)(Copyright) syndrome were reported in some people with Zika virus infection. There is currently no cure for or vaccine against the infection. VRC-ZKADNA085-00-VP is a new vaccine that instructs the body to make a small amount of Zika virus protein. The body may use this to build an immune response. Objective: To see if VRC-ZKADNA085-00-VP is safe and causes any side effects. Eligibility: Healthy people ages 18 35 Design: Participants will be screened through a separate protocol with: * Medical history * Physical exam * Lab and urine tests Participants will be randomly assigned to 1 of 4 study groups. They will have about 18 clinic visits over 2 years. Most will occur in the first year, with long-term follow-up visits at months 18 and 24. Visits include a physical exam and blood and urine tests. Participants will have vaccine injections. A high-pressure device pushes the vaccine through the skin and into the muscle of the upper arm. They will have 2-3 injections depending on their group. Vaccine visits last 4-6 hours. Others last 1-2 hours. Participants will keep a diary for 7 days after each injection. They will record their temperature and measure any skin changes at the injection site each day. Participants might have extra visits and blood tests if they have health changes.
Conditions Studied
Interventions
- BIOLOGICAL VRC-ZKADNA085-00-VP
Study Locations (3)
Maryland
- University of Maryland Ctr. for Vaccine Development - Baltimore
- National Institutes of Health Clinical Center - Bethesda
Georgia
- Hope Clinic - Emory Vaccine Ctr - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2016-08-02 |
| Est. Completion | 2019-03-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02840487
The ClinicalTrials.gov registry entry for NCT02840487 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 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 2 conditions, with Prevention of Zika Infection appearing as the primary indexed condition, and to 1 intervention - of which VRC-ZKADNA085-00-VP is the first listed.
NCT02840487 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Maryland, Georgia.
Frequently Asked Questions
What is clinical trial NCT02840487 about?
NCT02840487 is a clinical study titled "Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA085-00-VP, in Healthy Adults". Background: The Zika virus is passed to humans by infected mosquitos. It usually causes fever, rash, joint pain, and red eyes. Recently, some cases of microcephaly (abnormally small head) were reported in babies born to mothers infected with the Zika virus. Rare cases of a severe nerve weakness cal...
What is the current status of trial NCT02840487?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2016-08-02. Estimated completion is 2019-03-14.
What conditions does trial NCT02840487 study?
This clinical trial studies the following conditions: Prevention of Zika Infection, Zika-Specific Immune Response.
What interventions are being tested in trial NCT02840487?
The interventions under investigation include: VRC-ZKADNA085-00-VP (BIOLOGICAL).
Who is sponsoring clinical trial NCT02840487?
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 NCT02840487 being conducted?
This trial has 3 study locations across Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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