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VRC 320: A Phase I, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA090-00-VP, Administered Via Needle and Syringe or Needle-free Injector, PharmaJet, inHealthy Adults

NCT02996461 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-12-17

No results posted yet for this study

Summary

Background:

People get Zika virus from infected mosquitos. They usually don t get very sick. But birth defects were reported in babies born to mothers who had Zika infection. In rare cases, people with Zika infection had a nervous system disease that causes severe muscle weakness and can be life threatening. A new vaccine made from DNA in the code for a Zika virus protein could help the body build an immune response against the virus.

Objectives:

To see if a new vaccine against Zika virus disease is safe and causes any side effects. To study specific immune responses to the vaccine.

Eligibility:

Healthy people ages 18-50

Design:

Participants will be screened with:

Medical history

Physical exam

Urine tests

Participants will have 18 visits over 2 years.

Participants will be randomly assigned to 1 of 3 groups. All will get 3 vaccines at 3 separate monthly visits. They will receive the vaccine in the upper arm muscle. Some will get it by needle and syringe, others by a device that uses high pressure to push the vaccine through the skin.

Vaccine visits last 4-6 hours. Participants will get a thermometer to measure their temperature and a ruler to measure any skin changes at the injection site. They will record this data for 7 days after each injection.

Other visits last 1-2 hours. These include:

Evaluation of any health changes or problems

Blood tests: Some samples may be used for future research.

Participants with side effects may have extra visits.

...

Conditions

  • Prevention of Zika Infection
  • Zika-Specific Immune Response

Interventions

BIOLOGICAL

VRC-ZKADNA090-00-VP

VRC-ZKADNA090-00-VP is an investigational ZIKV DNA vaccine that is intended to prevent Zika virus infection.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Grace L Chen, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-12
Primary Completion
2019-09-03
Completion
2019-09-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02996461 on ClinicalTrials.gov