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Clinical Trial Summary

This study will include 5 cohorts of 14 flavivirus-naïve female subjects, 18 - 40 years of age (total: up to 70 subjects). Within each cohort, 10 subjects will receive ZIKV and 4 subjects will receive a placebo on Study Day 0. Cohorts 1 and 2 (Dose = 10^2 PFU) will be enrolled first. Cohorts 3 and 4 may be enrolled if dose escalation criteria are met (Section Enrollment into Cohort 5 may occur if dose escalation criteria are met following enrollment into Cohorts 3 and 4. Only one ZIKV strain will be evaluated in Cohort 5.

Clinical Trial Description

This study is a placebo-controlled, double-blind study in normal healthy adult female subjects 18 - 40 years of age, inclusive, recruited from the metropolitan Baltimore/Washington, DC and Burlington, VT areas. The purpose of this study is to evaluate the clinical and virologic response to escalating doses of 2 different ZIKV strains administered subcutaneously in healthy, flavivirus-naïve, non-pregnant, female adult volunteers to identify the most suitable ZIKV strain and dose for use in a ZIKV CHIM. The ZIKV CHIM will then be used to evaluate the protective efficacy of candidate ZIKV vaccines prior to evaluation of these candidates in Phase 2 clinical trials. Both ZIKV strains will be studied at doses of 10^2 PFU and 10^3 PFU. Only one of the ZIKV strains will be studied at a dose of 10^4 PFU. The ZIKV strain to be studied at 10^4 PFU will be determined following review of the data from the 10^2 and 10^3 PFU cohorts. Placebo recipients are included in the study as a control to better assess ZIKV-associated versus non-ZIKV-associated AEs. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05123222
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact Madeleine Blunt
Phone (443) 610-8568
Email [email protected]
Status Recruiting
Phase Phase 1
Start date November 30, 2021
Completion date August 31, 2023

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