Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 1 study of Avian Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT07019883 still lists
NCT07019883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Avian Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07019883's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01243931 · 80 participants · NA
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
- NCT01659203 · 80 participants · Phase 1
Proton or Photon RT for Retroperitoneal Sarcomas
- NCT01803451 · 80 participants · Early Phase 1
Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass
- NCT01964859 · 80 participants · Phase 2
Feasibility Study for Fibroblast Autologous Skin Grafts
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI