Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
VaxInnate Corporation
With
Bill and Melinda Gates Foundation
VAX102 is a cross-protective influenza A vaccine based on a recombinant protein expressed in E. coli. The protein comprises Salmonella typhimurium flagellin type 2 (STF2; TLR5 ligand) fused to Human M2e. The active component of the VAX102 vaccine is manufactured by a standard fermentation process. Unlike the HA and NA viral proteins, the amino acid sequence of M2e has remained remarkably stable in all human influenza A virus isolates. Thus an influenza vaccine based on the M2e antigen could elicit cross-protective immunity against most human influenza A virus strains. VAX102 vaccine relies on a single cross-reactive influenza A virus antigen manufactured by a recombinant protein fermentation-production process.
Age
18–49
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy adults aged 18-49 years inclusive who provide written informed consent to participate.
Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
You may not be if
Presence of significant acute or chronic, uncontrolled medical or psychiatric illness
Documented influenza infection in the 6 months prior to study entry.
Presently receiving or history of receiving any medications or treatments that affects the immune system
Acute disease within 72 hours prior to vaccinations Investigational product (test article) administrations will occur on Days 0 and 28 (± 3).
In-clinic safety evaluations will be performed at screening, before each test article dose, and at Days 1, 7 (± 2), 14 (± 2), 29, 35 (± 2), 42 (± 2), 60 (± 2), 120 (± 7), and 180 (± 7).
Completion of a Memory Aid for seven days following each vaccine dose will be requested of subjects for use in accurate recall of local and systemic reactions.
Clareo Health | Phase I Safety and Immunogenicity Study of VAX102 [Flagellin.HuM2e] Influenza Vaccine in Healthy Adults
