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NCT05968989 · ClinicalTrials.gov registry record · Phase 1
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) in Healthy Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT05968989: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05968989 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05968989, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
Background: Influenza (flu) virus causes 3 to 5 million cases of severe illness and up to 650,000 deaths per year worldwide. Current vaccines work well against single strains of flu virus. But no single vaccine works well against all flu viruses that can cause illness. Objective: To test an experimental flu vaccine (FluMos-v2) in healthy adults. Eligibility: Healthy adults aged 18 to 50 years. Design: Participants will have 11 clinic visits in 10 months. They must agree not to get a licensed flu vaccine while taking part in this study. FluMos-v2 will be given with a needle injected into a muscle in the upper arm. Participants will receive a follow-up phone call the following day. Participants will be given a diary card, a ruler, and a thermometer. They will take their temperature every day for 7 days after receiving the shot. They will measure any skin changes at the injection site. They will record their findings and how they feel. Participants will receive a second FluMos-v2 shot after 4 months. They will repeat the other follow-up steps. Participants will have 9 other clinic follow-up visits. Blood will be drawn at each visit. Participants should also come to the clinic if they develop flu-like symptoms during the study. Participants may opt for an apheresis 2 weeks after each shot: Blood will be removed through a needle in the vein of 1 arm. The blood will run through a machine that separates out the white blood cells. The remaining blood is returned through a needle in the other arm.
Primary Outcome
A 60 mcg dose of FluMos-v2 vaccine administered IM via needle on Day 0 and Week 16 to healthy adults.
Interventions
- BIOLOGICAL VRC-FLUMOS0116-00-VP( FLUMos-v2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-08-09 |
| Est. Completion | 2025-11-01 |
| Phase | Phase 1 |
What the finished NCT05968989 record still lists
NCT05968989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which VRC-FLUMOS0116-00-VP( FLUMos-v2) is the first listed.
NCT05968989 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05968989 about?
NCT05968989 is a clinical study titled "Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) in Healthy Adults". Background: Influenza (flu) virus causes 3 to 5 million cases of severe illness and up to 650,000 deaths per year worldwide. Current vaccines work well against single strains of flu virus. But no single vaccine works well against all flu viruses that can cause illness. Objective: To test an exper...
What is the current status of trial NCT05968989?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-08-09. Estimated completion is 2025-11-01.
What interventions are being tested in trial NCT05968989?
The interventions under investigation include: VRC-FLUMOS0116-00-VP( FLUMos-v2) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05968989?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05968989's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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