RNA Vaccines for COVID-19
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests three new COVID-19 RNA vaccines to evaluate their safety and ability to trigger an immune response in healthy adults. It includes different groups: some participants have never received a COVID-19 vaccine, while others have been vaccinated before. Participants will receive one of the vaccines—ARCT-021, ARCT-154, or ARCT-165—and the trial will assess their body's reaction. Individuals who have not had COVID-19 and have not been vaccinated in the past five months might be suitable candidates. As a Phase 1 and Phase 2 trial, this research aims to understand how the vaccines work in people and measure their effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it does exclude people who have received certain treatments like allergy injections, interferon, or immunomodulators, so it's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the investigational COVID-19 vaccines ARCT-021, ARCT-154, and ARCT-165 are generally safe for people.
Studies have found that ARCT-021 has a good safety record. Most side effects, such as pain at the injection site or mild flu-like symptoms, were mild or moderate and resolved on their own.
Similarly, trials showed that ARCT-154 was well tolerated. Most side effects were mild to moderate, like slight pain at the injection site. Unexpected side effects were rare and similar to those seen with a placebo.
For ARCT-165, data collection is ongoing, but early results are promising. It is being studied alongside ARCT-154 and has shown encouraging safety data.
Overall, these vaccines have been well tolerated, with mostly mild and temporary side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about ARCT-021, ARCT-154, and ARCT-165 because these COVID-19 vaccines use RNA technology, which is a newer approach compared to the traditional vaccines like those using inactivated virus or protein subunits. Unlike current options such as mRNA vaccines (e.g., Pfizer-BioNTech or Moderna), these vaccines might offer different delivery mechanisms or dosing schedules. These investigational vaccines could potentially enhance immune response or offer more flexibility in storage and distribution. This innovation could be crucial in improving global vaccination strategies and addressing variants of the virus more effectively.
What evidence suggests that this trial's treatments could be effective against COVID-19?
Research has shown that ARCT-021, one of the treatments in this trial, yields promising results. Early studies indicate strong immune responses and 100% antibody production after just one dose, suggesting effectiveness with a single shot. For ARCT-154, another treatment option in this trial, studies have revealed it is 56.6% effective against COVID-19 and 95.3% effective against severe cases, indicating strong protection against serious illness. The ARCT-165 vaccine, also under study in this trial, uses similar technology and has shown potential for a strong and lasting immune response even at lower doses. Overall, these vaccines appear promising in boosting immunity against COVID-19.12346
Who Is on the Research Team?
Clinical Program Director
Principal Investigator
Arcturus Therapeutics
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive study vaccines as 1 or 2 doses depending on cohort, with doses separated by 28 days for some groups
Follow-up
Participants are monitored for safety and effectiveness after treatment, including antibody response and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- ARCT-021
- ARCT-154
- ARCT-165
Find a Clinic Near You
Who Is Running the Clinical Trial?
Arcturus Therapeutics, Inc.
Lead Sponsor