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

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.

Timeline

Start

2022-07-01

Primary completion

2023-06-30

Completion

2023-08-22

Publications

• Dress RJ, Ho WW, Ho V, Lam JH, Decaillot FM, Sinsinbar G, Soo J, Rengasamy G, Khan AK, Cornell TA, Chia TW, Venkataraman S, Nallani M, Ginhoux F. A Novel Polymersome Nanocarrier Promotes Anti-Tumour Immunity by Improved Priming of CD8 + T Cells. Immunology. 2025 May;175(1):21-35. doi: 10.1111/imm.13903. Epub 2025 Jan 28.
• Nakahashi-Ouchida R, Fujihashi K, Kurashima Y, Yuki Y, Kiyono H. Nasal vaccines: solutions for respiratory infectious diseases. Trends Mol Med. 2023 Feb;29(2):124-140. doi: 10.1016/j.molmed.2022.10.009. Epub 2022 Nov 23.
• Lam JH, Shivhare D, Chia TW, Chew SL, Sinsinbar G, Aw TY, Wong S, Venkataraman S, Lim FWI, Vandepapeliere P, Nallani M. Artificial Cell Membrane Polymersome-Based Intranasal Beta Spike Formulation as a Second Generation Covid-19 Vaccine. ACS Nano. 2022 Oct 25;16(10):16757-16775. doi: 10.1021/acsnano.2c06350. Epub 2022 Oct 12.

Drugs

Indications