VRC 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
National Institute of Allergy and Infectious Diseases (NIAID)
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.
Description
Design: This is a phase I, open-label, dose escalation study to evaluate the safety, tolerability, and immunogenicity of the stem quadrivalent influenza vaccine VRC-FLUMOS0122-00-VP (SteMos1) with and without Army Liposome Formulation containing saponin QS-21 (ALFQ) adjuvant. The hypotheses are that the SteMos1 vaccine is safe and tolerable when administered alone or with ALFQ adjuvant, that this vaccine elicits vaccine specific immune responses, and that addition of the ALFQ adjuvant increases the magnitude and breadth of the elicited immune responses. The primary objective is to evaluate th…
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- Yes
* INCLUSION CRITERIA: A participant must meet all of the following criteria: * Healthy adults between the ages of 18-50 years, inclusive * Based on history and physical examination, be in good general health and without a history of any of the conditions listed in the exclusion criteria * Received at least one licensed influenza vaccine from the 2020-2021 influenza season through the 2024-2025 influenza season * Able and willing to complete the informed consent process * The ability to read and comprehend English as all consent and recruitment materials are in English. * Available for clinic…
Interventions
- BiologicalVRC-FLUMOS0122-00-VP
The VRC-FLUMOS0122-00-VP (SteMos1) is composed of de novo engineered pentamer assembled with de novo engineered trimeric domains to an icosahedral core, projecting 20 HA stabilized stem trimers from four influenza A strains representing both Group 1 (H2, H5) and Group 2 (H7, H10) viruses.
- OtherALFQ
The ALFQ drug product is a sterile suspension that contains 240 mcg of monophosphoryl 3-deacyl Lipid A (3D-PHAD) and 120 mcg QS-21
Location
- National Institutes of Health Clinical CenterBethesda, Maryland