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NCT07019883 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Immunogenicity of Two Doses of a Novel H5 Central Antigen mRNA-LNP in Healthy Adults
A Phase 1 study of Avian Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 3
- Study locations
NCT07019883 is a Phase 1 study of Avian Influenza that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 80 participants. The trial reports 3 study locations across 3 states.
The verdict
NCT07019883, a Phase 1 study of Avian Influenza, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a phase 1, multicenter, randomized, double-blind trial of two influenza A/H5 mRNA-based vaccines on healthy adult participants, 18-49 years of age. Stage 1 will serve as the open-label, dose finding stage. The first 10 participants will receive 12.5 mcg of H5 AC-Anhui RNA vaccine (Group 1), and the second 10 participants will receive 25 mcg of H5 AC-Anhui RNA vaccine (Group 2). After Protocol Safety Review Team (PSRT) review of reactogenicity and safety data through Day 8 for both Groups 1 and 2, another 10 participants may be enrolled to receive 50 mcg of H5 AC-Anhui RNA vaccine (Group 3). Safety data from 7 days after dose 2 for Groups 1 and 2 participants will be reviewed by the PSRT prior to clearing Group 3 participants for the second dose of vaccine. Individual participants will be followed for approximately 6 months following the second dose of vaccine. The primary objective is to assess the safety of two doses of H5 AC-Anhui RNA vaccine or H5-Astrakhan RNA vaccine administered intramuscularly in healthy adults (18-49 years). Once the Day 36 data from Group 3 are reviewed by the PSRT, a dose will be chosen (12.5 mcg, 25 mcg, or 50 mcg) for advancement to Stage 2 where 50 participants will be randomized 1:1 to receive either H5 AC-Anhui RNA (Group 4) or H5 Astrakhan RNA (Group 5) in a double-blinded manner.
Conditions Studied
Interventions
- OTHER Sodium Chloride, 0.9%
- BIOLOGICAL H5 AC-Anhui RNA Vaccine
- BIOLOGICAL H5 Astrakhan RNA Vaccine
Study Locations (3)
North Carolina
- Duke Vaccine and Trials Unit - Durham
Tennessee
- Vanderbilt University Medical Center - Nashville
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-06-12 |
| Est. Completion | 2026-05-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07019883
The ClinicalTrials.gov registry entry for NCT07019883 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 Avian Influenza appearing as the primary indexed condition, and to 3 interventions - of which Sodium Chloride, 0.9% is the first listed.
NCT07019883 reports 3 study locations spanning 3 distinct geographic areas - top geographies include North Carolina, Tennessee, Texas.
Frequently Asked Questions
What is clinical trial NCT07019883 about?
NCT07019883 is a clinical study titled "A Study to Evaluate the Safety and Immunogenicity of Two Doses of a Novel H5 Central Antigen mRNA-LNP in Healthy Adults". This is a phase 1, multicenter, randomized, double-blind trial of two influenza A/H5 mRNA-based vaccines on healthy adult participants, 18-49 years of age. Stage 1 will serve as the open-label, dose finding stage. The first 10 participants will receive 12.5 mcg of H5 AC-Anhui RNA vaccine (Group 1), ...
What is the current status of trial NCT07019883?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2025-06-12. Estimated completion is 2026-05-15.
What conditions does trial NCT07019883 study?
This clinical trial studies the following conditions: Avian Influenza.
What interventions are being tested in trial NCT07019883?
The interventions under investigation include: Sodium Chloride, 0.9% (OTHER), H5 AC-Anhui RNA Vaccine (BIOLOGICAL), H5 Astrakhan RNA Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT07019883?
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 NCT07019883 being conducted?
This trial has 3 study locations across North Carolina, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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