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

NCT05123222 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-04-11

Study results available
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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.

Conditions

  • Zika Virus

Interventions

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Anna Durbin, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-02-16
Primary Completion
2024-09-03
Completion
2024-09-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT05123222 on ClinicalTrials.gov