Leidos Biomedical Research, Inc., in support of the National Institute of Allergy and Infectious Diseases (NIAID) Division of Microbiology and Infectious Diseases (DMID) NextGen COVID-19 vaccine program, is advancing the development of a novel mRNA-LNP vaccine candidate with plans for a Phase 1 clinical trial in the United States. The initiative aims to bolster the arsenal of available vaccines against emerging SARS-CoV-2 variants.
To facilitate the clinical trial, Leidos Biomed is seeking a U.S.-based Contract Development and Manufacturing Organization (CDMO) to provide fill & finish services for the vaccine. The selected CDMO will be responsible for filling single-dose vials of the mRNA-LNP vaccine, utilizing ready-to-fill (RTF) bulk drug product supplied in single-use polyethylene terephthalate glycol (PETG) bottles.
The project is being conducted in accordance with current Good Manufacturing Practices (cGMP). Leidos Biomed is targeting the initiation of fill & finish services in the November – December 2024 timeframe, requiring the subcontractor to confirm their facility's capability to meet this timeline. The subcontractor will furnish all necessary services, qualified personnel, materials, equipment, and facilities.
The NIAID DMID NextGen program is designed to accelerate the development of next-generation COVID-19 vaccines that offer broader and more durable protection against the constantly evolving SARS-CoV-2 virus. This Phase 1 trial represents a crucial step in evaluating the safety and immunogenicity of the mRNA-LNP vaccine candidate.
With the ongoing evolution of SARS-CoV-2 and the potential for future pandemics, the development of novel vaccine platforms remains a critical priority for public health. The NextGen program and the planned Phase 1 trial underscore the commitment to staying ahead of the virus and ensuring continued protection against COVID-19.
