mRNA VLP Vaccine for COVID-19
(ARTEMIS-C Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two new vaccines, AZD9838 and AZD6563, to evaluate their safety and effectiveness in prompting the body to fight off COVID-19. Participants will receive one dose of either the new vaccines or a licensed mRNA vaccine for comparison. It suits adults who have had COVID-19 or completed their primary vaccination series at least six months ago and are generally healthy. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive these new vaccines.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it does mention restrictions on recent vaccinations and certain treatments like COVID-19 monoclonal antibodies. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that AZD9838 and AZD6563 are under study as single-dose COVID-19 vaccines. Currently, limited information exists about their safety in humans. They are in the early testing stages to ensure safety before larger trials commence.
So far, no clear reports of negative side effects have emerged. While this is generally positive, it doesn't guarantee that side effects won't appear as testing continues. At this stage, the main goal is to ensure the vaccines are well-tolerated. More safety information will become available as the study progresses.
It's important to remember that these vaccines remain under investigation. Joining a trial helps confirm their safety and effectiveness. Prospective participants should discuss potential risks and benefits with a healthcare professional.12345Why are researchers excited about this trial's treatments?
Researchers are excited about AZD9838 and AZD6563 because they represent a new wave of mRNA VLP vaccines for COVID-19. Unlike current vaccines that primarily use lipid nanoparticles to deliver mRNA, these treatments use virus-like particles (VLPs) to enhance immune response. This innovative approach could potentially provide a more robust and longer-lasting immunity against COVID-19. Additionally, these vaccines are designed to be effective with just a single intramuscular dose, which could simplify vaccination schedules and improve accessibility.
What evidence suggests that this trial's treatments could be effective against COVID-19?
In this trial, participants will receive different treatments to evaluate their effectiveness against COVID-19. Studies have shown that AZD9838, a treatment option in this trial, is safe and effectively boosts the immune system in adults, helping the body build a strong defense against COVID-19. Early results suggest it works like other approved mRNA vaccines. Meanwhile, initial data on AZD6563, another treatment option, indicate that even at low doses, it can trigger an immune response similar to existing vaccines. Both treatments offer promising ways to potentially enhance protection against COVID-19.12367
Are You a Good Fit for This Trial?
Adults aged 18-64 with a BMI under 35, who've had COVID-19 or been vaccinated against it at least 6 months ago. They must test negative for SARS-CoV-2 and be medically stable. Pregnant women, recent vaccine recipients, those with certain allergies or heart issues, and individuals with immune conditions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intramuscular dose of either AZD9838, AZD6563, or a licensed mRNA vaccine
Follow-up
Participants are monitored for safety and immunogenicity, including antibody response and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- AZD9838
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology