“Dose, Safety, Tolerability and Immunogenicity of an Influenza H1 Stabilized Stem Ferritin Vaccine, VRCFLUNPF099-00-VP, in Healthy Adults”
Background: The flu is a common viral infection that can be deadly for certain people. Vaccines against flu have been developed to teach the body to prevent or fight the infection. A new vaccine may help the body to make an immune response to H1 flu, a flu strain that infects humans. Objective: To test the safety and effectiveness of the H1 Stabilized Stem Ferritin vaccine (VRC-FLUNPF099-00-VP). Eligibility: Healthy people ages 18-70 years old who got at least 1 licensed flu vaccine since January 1, 2014. Design: Participants will have 1 or 2 vaccination visits over 4 months. Each will take about 4-6 hours. They will get the vaccine by injections (shots) in the upper arm muscle. Women who can get pregnant will have a pregnancy test before each injection. After each vaccination, participants will complete a diary card for 7 days. They will record their temperature, skin changes, and any symptoms that they may have. Participants will have 9-11 follow-up visits over 12-15 months. They will be checked for any health changes or problems. They will give blood samples and may give nose and throat swabs. Participants may have apheresis. A needle will be placed into a vein in both arms. Blood will be removed through a needle in the vein of one arm. A machine will remove the white blood cells and then the rest of the blood is returned to the participant through a needle in the other arm. Participants may sign a separate consent for genetic testing on their samples.
Biological - VRC-FLUNPF099-00-VP (H1ssF_3928)
The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/l999 (HlNl) genetically fused to the ferritin protein from H. pylori. Purified HlssF_3928 displays eight well-formed HA trimers that antigenically resemble the native Hl stem viral spikes.
VRC 321: A Phase I Open-Label Clinical Trial to Evaluate Dose, Safety, Tolerability, and Immunogenicity of an Influenza HI Stabilized Stem Ferritin Vaccine, VRCFLUNPF099-00-VP, in Healthy Adults