GMP Production and Clinical Trial of a Self-Assembling Protein Nanoparticle and Toll-Like Receptor Liposomal MPL Adjuvanted Malaria Vaccine
Abstract
A novel vaccine FMP014, adjuvanted with the Army Liposomal Formulation containing QS-21 (ALFQ) was assessed in a first-in human trial for safety and immunogenicity. FMP014 is a self-assembling icosahedral nanoparticle displaying the alpha-TSR domain of PfCSP, (NANP)6 CSP repeats, as well as two additional universal CD4+ epitopes specific to lymphatic choriomeningitis virus and influenza A virus. The vaccine was formulated in ALFQ, a liposomal adjuvant containing anionic vesicles 50 nm-30 mu m in size, composed of cholesterol, synthetic phospholipids containing dimyristoyl fatty acid groups, 3D-PHAD (a synthetic Monophosphoryl Lipid A analog) and the immune-stimulator QS-21 (a saponin derived from the bark of the Quillaja saponaria). The trial enrolled ten subjects. Five subjects assigned to the low dose group received 20 mu g of antigen (FMP014) with 0.5 mL of ALFQ, which contains 100 mu g 3D-PHAD and 50 mu g of QS-21. Five subjects were assigned to the high dose groups received 40 mu g of antigen (FMP014) and 1.0 mL of ALFQ, which contains 200 mu g 3D-PHAD and 100 mu g of QS-21. The trial included a 3-dose regimen with vaccinations at 0, 29, and 57 days. Solicited adverse events were collected for 7 days post each vaccination. Unsolicited adverse events and serious adverse events (SAEs) are being collected through the studies final visit. Antibody responses were assessed via ELISA. Initial data collected up to day 71 revealed that the vaccine displayed acceptable safety profiles and was immunogenic. Local solicited adverse events were generally mild and resolved by 72 hours. Systemic solicited adverse events were generally mild or absent in the low dose group and generally moderate in the high dose group. There were no related SAEs. Lab abnormalities were generally mild.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 01, 2022
- Accession Number
- AD1177036
Entities
People
- Evelina Angov