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NCT05123222 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Zika Virus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
56
Enrollment target
1
Study location

NCT05123222 is a Phase 1 study of Zika Virus that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 56 participants, below the 423-participant average among 3 other Zika Virus trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05123222, a Phase 1 study of Zika Virus, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
56 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL ZIKV-SJRP/2016-184 Strain
  • BIOLOGICAL Experimental: ZIKV-Nicaragua/2016 Strain

Study Locations (1)

Maryland

  • Johns Hopkins University, Bloomberg School of Public Health - Baltimore

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2022-02-16
Est. Completion 2024-09-03
Phase Phase 1

What the Registry Record Tells You About NCT05123222

The ClinicalTrials.gov registry entry for NCT05123222 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 423-participant average among 3 other Zika Virus trials with a reported enrollment target (87% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Zika Virus appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT05123222 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT05123222 about?

NCT05123222 is a clinical study titled "Evaluation of Two Zika Viruses for Use in Controlled Human Infection Models (CHIM)". 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...

What is the current status of trial NCT05123222?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2022-02-16. Estimated completion is 2024-09-03.

What conditions does trial NCT05123222 study?

This clinical trial studies the following conditions: Zika Virus.

What interventions are being tested in trial NCT05123222?

The interventions under investigation include: Placebo (BIOLOGICAL), ZIKV-SJRP/2016-184 Strain (BIOLOGICAL), Experimental: ZIKV-Nicaragua/2016 Strain (BIOLOGICAL).

Who is sponsoring clinical trial NCT05123222?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05123222 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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