243 Participants Needed

mRNA VLP Vaccine for COVID-19

(ARTEMIS-C Trial)

Recruiting at 4 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing two new vaccines, AZD9838 and AZD6563, in healthy adults to see if they are safe and help the immune system fight COVID-19.

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 the mRNA VLP Vaccine for COVID-19 safe for humans?

The VLP-based vaccine platform, used in the mRNA VLP Vaccine for COVID-19, is considered safe and has been well-tolerated in studies, with adverse reactions mostly being mild and temporary.12345

How is the mRNA VLP Vaccine for COVID-19 different from other COVID-19 treatments?

The mRNA VLP Vaccine for COVID-19 is unique because it uses virus-like particles (VLPs) that mimic the structure of the virus without containing its genetic material, making it safe and highly effective in triggering a strong immune response. This platform is flexible, allowing for easy updates to address new virus variants, and can be mass-produced and stored efficiently.12678

What data supports the effectiveness of the treatment AZD9838 in the mRNA VLP Vaccine for COVID-19 trial?

Virus-like particle (VLP) vaccines, like the one being studied, have shown to be effective in producing strong immune responses against COVID-19 by mimicking the virus structure without causing disease. Studies have demonstrated that VLP vaccines can induce high levels of neutralizing antibodies, which help block the virus from infecting cells, and have been effective in animal models.267910

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

I had COVID-19 or completed my initial COVID-19 vaccine series over 6 months ago.
Medically stable - according to the judgement of the investigator, hospitalization within the study is not anticipated and participant is likely to remain in the study through the end of the protocol specified follow-up
You need to have a negative COVID-19 test when you first visit the clinic.
See 1 more

Exclusion Criteria

History of hypersensitivity to any component of the study vaccination, severe adverse reaction associated with a vaccine and/or severe allergic reaction
You have or might have an autoimmune condition based on your medical history and physical examination.
Your troponin I levels are higher than normal during the initial screening.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular dose of either AZD9838, AZD6563, or a licensed mRNA vaccine

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, including antibody response and adverse events

12 months
Multiple visits over 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • AZD9838
Trial Overview The trial is testing the safety and effectiveness of AZD9838 as a single-dose mRNA VLP vaccine for COVID-19 in adults who have previously been infected or vaccinated. It's compared to an existing licensed mRNA vaccine.
How Is the Trial Designed?
8Treatment groups
Experimental Treatment
Active Control
Group I: Arm 7: dosage 2 of AZD6563 65 years of age and olderExperimental Treatment1 Intervention
Participants will receive 1 intramuscular dose of AZD6563.
Group II: Arm 6: dosage 1 of AZD6563 65 years of age and olderExperimental Treatment1 Intervention
Participants will receive 1 intramuscular dose of AZD6563.
Group III: Arm 5: dosage 2 of AZD6563 18 to 64 years of ageExperimental Treatment1 Intervention
Participants will receive 1 intramuscular dose of AZD6563.
Group IV: Arm 4: dosage 1 of AZD6563 18 to 64 years of ageExperimental Treatment1 Intervention
Participants will receive 1 intramuscular dose of AZD6563.
Group V: Arm 2: dosage 2 of AZD9838 18 to 64 years of ageExperimental Treatment1 Intervention
Participants will receive 1 intramuscular dose of AZD9838.
Group VI: Arm 1: dosage 1 of AZD9838 18 to 64 years of ageExperimental Treatment1 Intervention
Participants will receive 1 intramuscular dose of AZD9838.
Group VII: Arm 3: licensed mRNA vaccine 18 to 64 years of ageActive Control1 Intervention
Participants will receive 1 intramuscular dose of the licensed mRNA vaccine.
Group VIII: Arm 8: licensed mRNA vaccine 65 years of age and olderActive Control1 Intervention
Participants will receive 1 intramuscular dose of the licensed mRNA vaccine.

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

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

Published Research Related to This Trial

The study analyzed over 7.8 million adverse reactions from COVID-19 vaccines (AstraZeneca, Janssen, Moderna, Pfizer-BioNTech) and found a higher risk of serious adverse reactions compared to influenza vaccines, particularly in individuals aged 65 and older.
Serious adverse reactions typically occurred within the first week after vaccination, with the highest relative risks observed for allergic reactions, cardiovascular events, and thrombosis, highlighting the need for further research into the mechanisms behind these reactions.
Frequency and Associations of Adverse Reactions of COVID-19 Vaccines Reported to Pharmacovigilance Systems in the European Union and the United States.Montano, D.[2022]

Citations

Development and preclinical evaluation of virus-like particle vaccine against COVID-19 infection. [2022]
VLP-Based COVID-19 Vaccines: An Adaptable Technology against the Threat of New Variants. [2022]
Novel virus-like nanoparticle vaccine effectively protects animal model from SARS-CoV-2 infection. [2023]
A perspective on SARS-CoV-2 virus-like particles vaccines. [2023]
Safety, immunogenicity, and protection provided by unadjuvanted and adjuvanted formulations of a recombinant plant-derived virus-like particle vaccine candidate for COVID-19 in nonhuman primates. [2023]
A Review of Virus-Like Particle-Based SARS-CoV-2 Vaccines in Clinical Trial Phases. [2022]
Frequency and Associations of Adverse Reactions of COVID-19 Vaccines Reported to Pharmacovigilance Systems in the European Union and the United States. [2022]
Phase I study of a non-S2P SARS-CoV-2 mRNA vaccine LVRNA009 in Chinese adults. [2023]
Safety and immunogenicity of a heterologous booster with an RBD virus-like particle vaccine following two- or three-dose inactivated COVID-19 vaccine. [2023]
An Overview of Recent Developments in the Application of Antigen Displaying Vaccine Platforms: Hints for Future SARS-CoV-2 VLP Vaccines. [2023]
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