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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: Completed Phase 1 study of Zika Virus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
measured by count of solicited adverse events recorded following ZIKV administration
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
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2022-02-16 |
| Est. Completion | 2024-09-03 |
| Phase | Phase 1 |
What the finished NCT05123222 record still lists
NCT05123222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 423-participant average among 3 other Zika Virus trials with a reported enrollment target (87% lower).
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 a single indexed study location in 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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