Recruiting

Quadrivalent Influenza HA Stem Vaccine Safety and Immune Response in Healthy Adults

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What is being tested

VRC-FLUMOS0122-00-VP (SteMos1) with and without Army Liposome Formulation containing saponin QS-21 (ALFQ) Adjuvant

Biological
Who is being recruted

From 18 to 50 Years
+50 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 1
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Study ContactVRC Clinic
Last updated: January 23, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 27, 2025

Actual date on which the first participant was enrolled.

This study focuses on testing a new flu vaccine called SteMos1, which aims to protect against four types of influenza viruses. The vaccine's safety, how well it is tolerated, and its ability to trigger an immune response are being evaluated. The study includes healthy adults and looks at different doses of the vaccine, both with and without an additional substance called ALFQ, which may enhance the vaccine's effectiveness. The goal is to ensure the vaccine is safe and effective, potentially leading to better flu protection in the future. Participants in this study receive two doses of the vaccine through an injection in the muscle. Researchers observe any side effects or reactions for a week following each injection and monitor for any other health issues over a month. The study measures immune responses by checking antibody levels two weeks after each dose. Some participants receive the vaccine with the ALFQ adjuvant, while others do not, allowing researchers to compare the effects. The study also explores different types of immune responses over time, contributing valuable information on how well the vaccine might work in preventing flu.

Official TitleVRC 329: A Phase I Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP (STEMos1) With and Without ALFQ Adjuvant in Healthy Adults 
NCT07111078
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Study ContactVRC Clinic
Last updated: January 23, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

56 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

22 inclusion criteria required to participate
Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on the day of enrollment (applicable to women of childbearing potential)
Agrees to use an effective means of birth control from at least 21 days prior to enrollment through the end of the study (applicable to women of childbearing potential)
Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) <= 35 within the 56 days before enrollment
Total lymphocyte count >= 800 cells/microliter
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28 exclusion criteria prevent from participating
Receipt of any licensed influenza vaccine or lab-confirmed influenza infection within 6 months prior to enrollment.
Plan to or are required to receive the 2025-2026 or 2026-2027 licensed influenza vaccines
Live attenuated vaccines within 4 weeks prior to enrollment
Inactivated vaccines within 2 weeks prior to enrollment
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
60 mcg of SteMos1 on Day 0 and Week 16

Group II

Experimental
180 mcg of SteMos1 on Day 0 and Week 16

Group III

Experimental
60 mcg of SteMos1 + 0.5 ml of ALFQ on Day 0 and Week 16

Group IV

Experimental
180 mcg of SteMos1 + 0.5 ml of ALFQ on Day 0 and Week 16

Group 5

Experimental
SteMos1 \[dose TBD based on interim analysis of data from Groups 3-4\] + 0.5 ml of ALFQ on Day 0 and Week 16

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Institutes of Health Clinical Center

Bethesda, United StatesSee the location
Recruiting
One Study Center