CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 56 enrolled
Drug / intervention
Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml) +2 morebiological
Likely dose
Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml)from 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/NCT03611946
NCT03611946Phase 1Completed
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Phase I Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 2, 2018·Updated Aug 5, 2025

In Brief

A Phase 1 clinical trial evaluating Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml), Single dose of placebo via subcutaneous injection (0.5ml)., and 1 other intervention for Zika Virus. Completed, enrolled 56 participants across 2 sites.

Detailed Summary

This is a phase 1 double-blind, placebo controlled trial designed to evaluate the safety, reactogenicity, and immunogenicity of a single dose of the live attenuated Zika vaccine rZIKV/D4Δ30-713 in adults with no history of previous flavivirus infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsZika Virus
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedAug 2, 2018
Enrollment StartJul 6, 2018
Primary CompletionMar 18, 2022
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 7.9 years ago

Interventions

Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml)biological

Administered at a dose of 10\^3 plaque-forming units (PFUs) by subcutaneous injection

Single dose of placebo via subcutaneous injection (0.5ml).biological

Administered by subcutaneous injection.

Single dose of rZIKV/D4Δ30-713 (10^4 PFU) via subcutaneous injection (0.5ml)biological

Administered at a dose of using 10\^4 plaque-forming units (PFUs) by subcutaneous injection.