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

Zika Virus Clinical Trial

Official title:
Phase I Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults

Clinical Trial Summary

The purpose of this study is 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.

Clinical Trial Description

This study will 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. Participants will be randomly assigned to receive a single dose of either rZIKV/D4Δ30-713 or placebo at study entry (Day 0). Study visits will occur on Days 0, 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, 150, and 180. Visits may include a physical examination; blood, urine, saliva, nasopharyngeal (NP) or midturbinate swab, vaginal secretions, and semen collection; and pregnancy testing. SARS-CoV-2 PCR (nasopharyngeal or mid-turbinate swab) will be performed during screening and on days 0, 8, and 14. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03611946
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Start date July 6, 2018
Completion date March 18, 2022
View Details
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