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NCT06863142 · ClinicalTrials.gov registry record · Phase 1
Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults
A Phase 1 study of Seasonal Influenza and Influenza Prevention, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT06863142: Recruiting Phase 1 study of Seasonal Influenza and Influenza Prevention, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06863142 is a Phase 1 study of Seasonal Influenza and Influenza Prevention that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 45 participants, below the 436-participant average among 3 other Seasonal Influenza trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06863142, a Phase 1 study of Seasonal Influenza and Influenza Prevention, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Vaccines help the body learn to fight infections. Some vaccines are combined with adjuvants, which are added substances that make vaccines work better. FluMos-v2 is an experimental flu vaccine; ALFQ is an experimental adjuvant. Objective: To test FluMos-v2, with and without the ALFQ adjuvant, in healthy adults. Eligibility: Healthy adults aged 18 to 50 years. They must have received at least one flu vaccine from the 2020-21 season through the 2024-25 flu season. They must also agree not to receive the licensed 2025-26 flu vaccine. Design: Participants will have 12 clinic visits over 15 months. Participants will be screened. They will have a physical exam and blood tests. On 2 visits, about 4 months apart, participants will receive a vaccination. The shots will be given into the muscle of the upper arm. They will get a follow-up call the day after each shot. They will keep a daily diary for 7 days; they will record their temperature and any other symptoms they feel after each shot. All clinic visits will include collection of blood, saliva, and nasal secretions. If participants develop flu symptoms (such as fever, runny nose, sore throat), they will be asked to come to the clinic. About 2 weeks after each vaccination, participants may opt to undergo apheresis: Blood will be taken from the body through a needle inserted into one arm. 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 needle in the other arm.
Primary Outcome
To evaluate the safety and tolerability of a 2 dose regimen with ALFQ adjuvant.
Conditions Studied
Interventions
- BIOLOGICAL VRC-FLUMOS0116-00-VP
- OTHER ALFQ
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2025-04-28 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 1 |
What NCT06863142 shows while recruiting
NCT06863142 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 436-participant average among 3 other Seasonal Influenza trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Seasonal Influenza appearing as the primary indexed condition, and to 2 interventions - of which VRC-FLUMOS0116-00-VP is the first listed.
NCT06863142 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06863142 about?
NCT06863142 is a clinical study titled "Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults". Background: Vaccines help the body learn to fight infections. Some vaccines are combined with adjuvants, which are added substances that make vaccines work better. FluMos-v2 is an experimental flu vaccine; ALFQ is an experimental adjuvant. Objective: To test FluMos-v2, with and without the ALFQ a...
What is the current status of trial NCT06863142?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2025-04-28. Estimated completion is 2026-07-31.
What conditions does trial NCT06863142 study?
This clinical trial studies the following conditions: Seasonal Influenza, Influenza Prevention.
What interventions are being tested in trial NCT06863142?
The interventions under investigation include: VRC-FLUMOS0116-00-VP (BIOLOGICAL), ALFQ (OTHER).
Who is sponsoring clinical trial NCT06863142?
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 NCT06863142 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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