A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Pandemic Flu Vaccine in Healthy Adults
Public ClinicalTrials.gov record NCT05397119. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Ph1 Randomized Double-Blind Controlled Dose-Range Safety Tolerability & Immunogenicity Study of 2 Doses of Intranasal rH5 Flu Vaccine With & Without Nanoemulsion Adjuvant Followed by 1 Boost of Intramuscular H5N1 Vaccine in Healthy Adults
Study identification
- NCT ID
- NCT05397119
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- BlueWillow Biologics
- Industry
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Interventions
- BW-1014: 100 µg rH5 in 20% NE - pipette - IN Biological
- BW-1014: 25 µg rH5 in 20% NE - pipette - IN Biological
- BW-1014: 50 µg rH5 in 20% NE - pipette - IN Biological
- H5N1 IIV - IM Biological
- Saline (Placebo) - pipette - IN Biological
- rH5 (100 µg) control - pipette - IN Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 6, 2022
- Primary completion
- Oct 11, 2023
- Completion
- Oct 11, 2023
- Last update posted
- Aug 21, 2024
2022 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Center for Vaccine Development and Global Health, University of Maryland School of Medicine | Baltimore | Maryland | 21201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05397119, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 21, 2024 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05397119 live on ClinicalTrials.gov.