Booster Dose Study to Assess the Safety and Immunogenicity of ACM-001 Administered Intramuscularly or Intranasally.

An open label, randomized, dose comparison, sequential cohorts study design in healthy volunteers (young adults) is a frequently used design in vaccine Phase 1 studies. ACM-001 is developed as a booster vaccine against SARS-CoV-2 after a full primary vaccination with or without 1-2 booster doses (2 or 3 or 4 doses) schedule with any registered and commercial SARS-CoV-2 vaccines. The plan is to start with a low dosage of antigen alone, followed by a combination of antigen and adjuvant and then to progress to higher dosages to define the safety profile of the candidate vaccine as primary endpoint, and its immunogenicity as secondary endpoint.