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NCT07111078 · ClinicalTrials.gov registry record · Phase 1
Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP (SteMos1) With and Without ALFQ Adjuvant in Healthy Adults
A Phase 1 study of Influenza Prevention and Pandemic Influenza Prevention, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT07111078: Recruiting Phase 1 study of Influenza Prevention and Pandemic Influenza Prevention, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT07111078 is a Phase 1 study of Influenza Prevention and Pandemic Influenza Prevention that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07111078, a Phase 1 study of Influenza Prevention and Pandemic Influenza Prevention, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Influenza (flu) is a contagious respiratory illness caused by viruses. Flu symptoms can range from mild to severe, and the illness can be fatal. Vaccines help the body learn to prevent or fight infections such as flu. Some vaccines are combined with adjuvants. Adjuvants are special salts or fats that help vaccines work better. Researchers are looking for ways to make flu vaccines more effective. Objective: To test a new flu vaccine with and without a new adjuvant. Eligibility: Healthy adults aged 18 to 50. They must have had at least 1 flu vaccine since 2020. Design: Participants will have 12 clinic visits over 15 months. The vaccine is given as an injection into the muscle of the upper arm. Participants will be vaccinated during 2 visits spaced 4 months apart. Half will receive just the vaccine; half will receive the vaccine plus the adjuvant. They will be monitored for at least 30 minutes after each shot. Participants will keep a diary for 7 days after each shot. They check their temperature every day and record any symptoms. Participants will have 10 follow-up clinic visits plus 4 phone calls. They will have 4 to 10 tablespoons of blood drawn at each clinic visit. Fluid samples will be collected from their nose and mouth. They will be checked for any health changes. Participants may opt to undergo apheresis: Blood will be taken from the body through a needle inserted into a vein. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be returned to the body through a different needle.
Primary Outcome
Assessed by:-Frequency and severity of solicited local reactogenicity symptoms reported for 7 days following each injection, through resolution of symptoms.-Frequency and severity of solicited systemic reactogenicity symptoms reported for 7 days following each injection, through the resolution of symptoms.-Frequency and grade of any unsolicited AEs, including abnormal safety laboratory measures, during the 28-day follow-up period post each product administration.-Frequency and grade of unsolicit
Conditions Studied
Interventions
- BIOLOGICAL VRC-FLUMOS0122-00-VP (SteMos1) with and without Army Liposome Formulation containing saponin QS-21 (ALFQ) Adjuvant
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2025-08-27 |
| Est. Completion | 2027-08-18 |
| Phase | Phase 1 |
What NCT07111078 shows while recruiting
NCT07111078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 2 conditions, with Influenza Prevention appearing as the primary indexed condition, and to 1 intervention - of which VRC-FLUMOS0122-00-VP (SteMos1) with and without Army Liposome Formulation containing saponin QS-21 (ALFQ) Adjuvant is the first listed.
NCT07111078 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT07111078 about?
NCT07111078 is a clinical study titled "Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP (SteMos1) With and Without ALFQ Adjuvant in Healthy Adults". Background: Influenza (flu) is a contagious respiratory illness caused by viruses. Flu symptoms can range from mild to severe, and the illness can be fatal. Vaccines help the body learn to prevent or fight infections such as flu. Some vaccines are combined with adjuvants. Adjuvants are special salt...
What is the current status of trial NCT07111078?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2025-08-27. Estimated completion is 2027-08-18.
What conditions does trial NCT07111078 study?
This clinical trial studies the following conditions: Influenza Prevention, Pandemic Influenza Prevention.
What interventions are being tested in trial NCT07111078?
The interventions under investigation include: VRC-FLUMOS0122-00-VP (SteMos1) with and without Army Liposome Formulation containing saponin QS-21 (ALFQ) Adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT07111078?
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 NCT07111078 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07111078's enrollment target sits among peer trials
56 903rd of 2000 higher than 1,083 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
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