MedTrace Logo

Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults

NCT03611946 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-08-05

Study results available
· View outcomes & findings →

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.

Conditions

  • Zika Virus

Interventions

BIOLOGICAL

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

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

BIOLOGICAL

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

Administered by subcutaneous injection.

BIOLOGICAL

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

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Anna Durbin, MD · Center for Immunization Research, Johns Hopkins School of Public Health

  • Kristen Pierce, MD · University of Vermont

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-07-06
Primary Completion
2022-03-18
Completion
2022-03-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03611946 on ClinicalTrials.gov