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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.
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Exclusion criteria
DocuSign Envelope ID: C34D91C3-4686-427D-BB78-CF7178216E74 Endpoints 21. Close contact with laboratory-confirmed COVID-19 cases within 10 days prior to vaccination, high risk of exposure or has an occupation with a high risk of exposure to SARS-CoV-2 (emergency response); 22. Pregnancy confirmed by a positive pregnancy test, lactation or intention to become pregnant during the study; 23. Any cancer diagnosed and/or treated within the past 5 years (except basal cell carcinoma of the skin and cervical carcinoma in situ); 24. Veins not suitable for repeated blood sampling; 25. Serious reaction, such as anaphylactic reaction, following primary COVID-19 vaccination; 26. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results; 27. Sponsor employees or Investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted, including children of newly composed families.
Primary purpose
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Interventional model
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38 participants in 8 patient groups
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Central trial contact
Pierre Vandepapeliere, MD,PhD; Janice Henrichs
Data sourced from clinicaltrials.gov
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