Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA085-00-VP, in Healthy Adults
VRC 319: A Phase I/Ib, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of A Zika Virus DNA Vaccine, VRC-ZKADNA085-00-VP, in Healthy Adults
Other study identifiers
Sponsor study identifier
Secondary identifiers
interventional
80
1 country
3
Study Start
August 2, 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 14, 2019
Actual (reported)Study Completion
March 14, 2019
Actual (reported)Brief 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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 80 participants
- Study completion date
March 14, 2019
Actual (reported)- Listed locations
- 1 countries · 3 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
July 19, 2016
Actual (reported)First Posted
July 21, 2016
Actual (reported)Study Start
August 2, 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 14, 2019
Actual (reported)Study Completion
March 14, 2019
Actual (reported)
- Last Updated
- March 18, 2019
- Status Verified
- March 14, 2019
- Last Update Submitted
- March 15, 2019