Purpose: The Vaccine Research Center (VRC) at the NIH is developing a developed a series of pandemic flu vaccine candidate centered around self-assembling Ferritin-Hemagglutinin nanoparticle (HAF), intended to elicit responses across multiple influenza strains (Group 1 and Group 2). The VRC has optimized the formulation for Group 1 stabilized stem and currently working on optimal formulation for Group 2 stabilized stem. The goal is to combine stabilized stem flu vaccine candidates from Groups 1 and 2 to create a Universal flu vaccine candidate targeting all Flu strains. This study describes pre-formulation development studies of stabilized stem universal flu nano-particle vaccine candidates for a Phase I clinical trial.
Methods: CD, DSC, FTIR, DLS, SEC, GXII, ICD and Fluorescence
Results: Group 2 stabilized stem showed comparable basal biophysical properties similar to Group 1 stabilized stem.
Conclusion: Preliminary ICD results suggests an optimal pH range of 7-7.5. Currently optimizing solution conditions for stability evaluation.