ARCT-021
ARCT-021 is an investigational vaccine candidate developed by Arcturus Therapeutics for the prevention of COVID-19. It is based on the mRNA technology and utilizes the company's proprietary LUNAR platform for delivery.
Overview
ARCT-021 is a self-replicating RNA vaccine, which means it can produce multiple copies of the SARS-CoV-2 spike protein within the body to stimulate an immune response. This is different from traditional vaccines, which often require a booster shot to achieve the desired level of immunity.
Development and Clinical Trials
The development of ARCT-021 began in early 2020, following the outbreak of the COVID-19 pandemic. The vaccine entered Phase 1/2 clinical trials in August 2020, with preliminary results showing a strong immune response with a single dose.
In December 2020, Arcturus Therapeutics announced that it would proceed to Phase 2 trials, with plans for a Phase 3 trial to follow. The company is also exploring the potential for ARCT-021 to be used as a booster vaccine for individuals who have already received a different COVID-19 vaccine.
Mechanism of Action
ARCT-021 works by introducing a small piece of the SARS-CoV-2 virus's genetic material into the body. This genetic material instructs cells to produce the spike protein found on the surface of the virus. The immune system then recognizes this protein as foreign and produces antibodies to fight it. If the individual is later exposed to the actual virus, their immune system is prepared to fight it off.
Safety and Efficacy
In the Phase 1/2 clinical trials, ARCT-021 was generally well-tolerated with no serious adverse events reported. The most common side effects were mild to moderate and included fatigue, headache, and injection site pain.
The vaccine demonstrated a strong immune response in participants, with high levels of neutralizing antibodies and T cell responses observed. Further studies are needed to confirm these results and to determine the duration of immunity provided by the vaccine.
See Also
References
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Contributors: Prab R. Tumpati, MD