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Cancer Vaccine

mRNA VLP Vaccine for COVID-19 (ARTEMIS-C Trial)

Phase 1

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults ≥ 18 to 64 years at the time of signing informed consent

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 12 months post vaccination

Awards & highlights

ARTEMIS-C Trial Summary

This trial tested a single-dose Covid-19 vaccine in adults to see if it is safe & effective.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include typical reactions to vaccines such as soreness at injection site, fever, fatigue, headache, muscle pain. Severe allergic reactions could occur but are rare.

ARTEMIS-C Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 64 years old.

ARTEMIS-C Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 12 months post vaccination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 12 months post vaccination

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 12 months post vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events of special interest (AESI)

Incidence of immediate unsolicited adverse events (AE)

Incidence of medically attended adverse events (MAAE)

+3 more

Secondary outcome measures

Geometric mean fold rise (GMFR) for SARS-CoV-2 Beta variant S protein binding antibodies

Geometric mean fold rise (GMFR) for SARS-CoV-2 Delta variant S protein binding antibodies

Geometric mean fold rise (GMFR) for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies

+20 more

ARTEMIS-C Trial Design

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.

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,612,360 Total Patients Enrolled

52 Trials studying COVID-19

256,197,282 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widely dispersed is the research being conducted for this investigation?

"Presently, this clinical trial is being administered in 5 different medical centres. These facilities are located in Rolling Hills Estates, Chicago and Wichita among other cities. Patients should select the nearest site to them to minimize travel obligations during their participation."

Answered by AI

Are new participants being sought for this experiment?

"The information on clinicaltrials.gov indicates that this trial is not taking new participants anymore, as the last update was made November 24th 2023. Nevertheless, there are currently 740 other studies available for potential enrolment."

Answered by AI

What characteristics make a person an ideal candidate for this trial?

"This medical trial is seeking 90 individuals who have been diagnosed with covid-19 and are between 18 and 64 years old."

Answered by AI

Does this research embrace individuals aged 20 and above?

"This medical experiment is open to individuals aged 18-64. For those below the age of consent, there are 100 trials available and for those above 65, 646 clinical studies can be accessed."

Answered by AI

Has the FDA given its sanction for AZD9838 dosage 1 to be administered to individuals aged 18-64 in Arm 1?

"Our experts at Power gave Arm 1: dosage 1 of AZD9838 an overall safety score of 1, as this is a Phase 1 clinical trial. This means that there are limited studies demonstrating the medication's efficacy and safety in 18 to 64 year olds."

Answered by AI

What are the prospective goals of this research endeavor?

"According to the trial sponsor, AstraZeneca, the primary outcome will be assessed over a 28-day period post vaccination and is termed Medically Attended Adverse Events (MAAE). This study also examines secondary outcomes such as Proportion of Participants with S protein binding antibody seroresponse against SARS-CoV-2 Omicron subvariant, Geometric Mean Titer for SARS-CoV-2 Omicron XBB.1.5 Neutralizing Antibodies, and Geometric Mean Fold Rise in response to the Delta Variant of SARS CoV-2's Binding Protein Antib"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Randomized Trial Evaluating a mRNA-VLP Vaccine's Immunogenicity and Safety for COVID-19

2023. "A Randomized Trial Evaluating a mRNA-VLP Vaccine's Immunogenicity and Safety for COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06147063.

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