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Clinical Trials associated with VRC-FLUMOS0116-00-VPVRC 328: A Phase I Open-Label Clinical Trial to Evaluate the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-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 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 2023-24 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 are 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.
/ Active, not recruitingPhase 1IIT VRC 326 (001614): A Phase I Open-Label Clinical 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 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.
100 Clinical Results associated with VRC-FLUMOS0116-00-VP
100 Translational Medicine associated with VRC-FLUMOS0116-00-VP
100 Patents (Medical) associated with VRC-FLUMOS0116-00-VP
100 Deals associated with VRC-FLUMOS0116-00-VP
