CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2,428 enrolled
Drug / intervention
VRC-ZKADNA090-00-VP +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03110770
NCT03110770Phase 2Completed
CompareCT.gov

VRC 705: A Phase 2/2B, Randomized Trial to Evaluate the Safety, Immunogenicity and Efficacy of a Zika Virus DNA Vaccine in Healthy Adults and Adolescents

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Apr 12, 2017·Updated Jan 31, 2024

In Brief

A Phase 2 clinical trial evaluating VRC-ZKADNA090-00-VP and VRC-PBSPLA043-00-VP for Zika Virus and 6 related conditions. Completed, enrolled 2,428 participants across 17 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsZika Virus, Zika Virus Infection, Virus Diseases, Flavivirus Infections, Flaviviral Diseases, Flaviviridae Infections, RNA Virus Infections
CountriesBrazil, Colombia, Costa Rica, Ecuador, Mexico, Panama, Peru, Puerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 12, 2017
Enrollment StartMar 29, 2017
Primary CompletionOct 4, 2019
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.2 years ago

Interventions

VRC-ZKADNA090-00-VPbiological

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

VRC-PBSPLA043-00-VPother

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