CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 56 enrolled
Drug / intervention
ZIKV-SJRP/2016-184 Strain +2 morebiological
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Age 18–40 years, adult
  • ✓ZIKV and dengue-naïve (no prior infection)
  • ✓Good general health by examination, laboratory, and medical history
  • ✓Available for entire ~26 weeks post-inoculation
Key exclusion· 10
  • ✕Pregnant, breastfeeding, or planning pregnancy during 6-month study
  • ✕Significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
  • ✕Recent opiate use on urine toxicology
  • ✕HIV, HCV, or HBV infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05123222
NCT05123222Phase 1Completed
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Phase I Evaluation of Two Zika Viruses for Use in Controlled Human Infection Models (CHIM)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Nov 17, 2021·Updated Apr 11, 2025

In Brief

A Phase 1 clinical trial evaluating ZIKV-SJRP/2016-184 Strain, Experimental: ZIKV-Nicaragua/2016 Strain, and 1 other intervention for Zika Virus. Completed, enrolled 56 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedNov 17, 2021
Enrollment StartFeb 16, 2022
Primary CompletionSep 3, 2024
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 4.6 years ago

Interventions

ZIKV-SJRP/2016-184 Strainbiological

Zika Virus Strain (San Jose Rio Puerto)

Experimental: ZIKV-Nicaragua/2016 Strainbiological

Zika Virus Strain (Nicaragua)

Placebobiological

Saline