NCT05123222

Evaluation of Two Zika Viruses for Use in Controlled Human Infection Models (CHIM)

Phase I Evaluation of Two Zika Viruses for Use in Controlled Human Infection Models (CHIM)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study will include 4 cohorts of 14 ZIKV and DENV-naïve female and male subjects, 18 - 40 years of age (total: up to 56 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 and will enroll only women. Cohorts 3 and 4 (Dose = 10\^2 PFU) will enroll men.

Detailed description

This study is a placebo-controlled, double-blind study in normal healthy adult male and non-pregnant 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, ZIKV and DENV-naïve, male and 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. Placebo recipients are included in the study as a control to better assess ZIKV-associated versus non-ZIKV-associated AEs.

Conditions

• Zika Virus

Interventions

Type	Name	Description
BIOLOGICAL	ZIKV-SJRP/2016-184 Strain	Zika Virus Strain (San Jose Rio Puerto)
BIOLOGICAL	Experimental: ZIKV-Nicaragua/2016 Strain	Zika Virus Strain (Nicaragua)
BIOLOGICAL	Placebo	Saline

Timeline

• Start date: 2022-02-16
• Primary completion: 2024-09-03
• Completion: 2024-09-03
• First posted: 2021-11-17
• Last updated: 2025-04-11
• Results posted: 2025-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study