An Open Label, Randomized, Dose and Route of Administration Comparison Phase 1 Study to Evaluate the Safety and Immunogenicity of the ACM-SARS-CoV-2-beta With ACM-CpG Vaccine Candidate (ACM-001), Administered Intramuscularly or Intranasally as a Booster Dose in Healthy Adults Aged 18 to 55 Years, Who Were Previously Vaccinated Against SARS-CoV-2.

Detailed Summary

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.

Study Details

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