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VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents

NCT03110770 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2428

Last updated 2024-01-31

Study results available
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Summary

This was a multicenter, randomized study to evaluate the safety, immunogenicity, and efficacy of VRC-ZKADNA090-00-VP (Zika virus wildtype DNA vaccine) or placebo. In Part A, the primary objective was to evaluate the safety and tolerability of the vaccine in different vaccination regimens. In Part B, the primary objectives were to evaluate the safety and efficacy of the vaccine compared to placebo.

Conditions

  • Zika Virus
  • Zika Virus Infection
  • Virus Diseases
  • Flavivirus Infections
  • Flaviviral Diseases
  • Flaviviridae Infections
  • RNA Virus Infections

Interventions

BIOLOGICAL

VRC-ZKADNA090-00-VP

VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV

OTHER

VRC-PBSPLA043-00-VP

A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Julie Ledgerwood, DO · VRC, NIAID, NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
15 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-29
Primary Completion
2019-10-04
Completion
2019-10-04
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Colombia
  • Costa Rica
  • Ecuador
  • Mexico
  • Panama
  • Peru
  • Puerto Rico

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 NCT03110770 on ClinicalTrials.gov