A Study on the Safety, Tolerability and Immune Response of SARS-CoV-2 Sclamp (COVID-19) Vaccine in Healthy Adults

Summary

This study is being conducted to look at the safety and immune response (how the immune system of the human body reacts) to a vaccine for SARS-CoV-2 (the virus responsible for COVID-19 infection) when administered as an intramuscular injection (an injection directly into the muscle) to the upper arm of healthy participants, on two occasions at least 28 days apart.

Timeline

Start

2020-07-13

Primary completion

2024-04-30

Completion

2024-04-30

Publications

• Chappell KJ, Mordant FL, Amarilla AA, Modhiran N, Liang B, Li Z, Wijesundara DK, Lackenby JA, Griffin P, Bennet JK, Hensen L, Zhang W, Nguyen THO, Tran MH, Tapley P, Barnes J, Reading PC, Kedzierska K, Ranasinghe C, Subbarao K, Watterson D, Young PR, Munro TP. Long-term safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2 in adults aged 18-55 years or >/=56 years: 12-month results from a randomised, double-blind, placebo-controlled, phase 1 trial. EBioMedicine. 2023 Nov;97:104842. doi: 10.1016/j.ebiom.2023.104842. Epub 2023 Oct 20.
• Chappell KJ, Mordant FL, Li Z, Wijesundara DK, Ellenberg P, Lackenby JA, Cheung STM, Modhiran N, Avumegah MS, Henderson CL, Hoger K, Griffin P, Bennet J, Hensen L, Zhang W, Nguyen THO, Marrero-Hernandez S, Selva KJ, Chung AW, Tran MH, Tapley P, Barnes J, Reading PC, Nicholson S, Corby S, Holgate T, Wines BD, Hogarth PM, Kedzierska K, Purcell DFJ, Ranasinghe C, Subbarao K, Watterson D, Young PR, Munro TP. Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Infect Dis. 2021 Oct;21(10):1383-1394. doi: 10.1016/S1473-3099(21)00200-0. Epub 2021 Apr 19.

Drugs

Indications