What side effects are associated with this type of intervention?

Common side effects of COVID-19 vaccines, including those similar to AZD9838 and AZD6563, typically include local reactions at the injection site (pain and tenderness) and systemic reactions (fatigue, headache, muscle pain, chills, fever, and nausea). Rare but serious adverse events, such as thromboembolic and thrombocytopenic events, have also been reported. Overall, these vaccines have a favorable safety profile, with most side effects being mild to moderate and resolving within a few days.

What prior FDA approvals exist?

The FDA has granted Emergency Use Authorization (EUA) for several vaccines that stimulate an immune response against SARS-CoV-2. These include the Pfizer-BioNTech COVID-19 vaccine (BNT162b2), Moderna COVID-19 vaccine (mRNA-1273), and the Johnson & Johnson vaccine (Ad26.COV2.S). Both Pfizer-BioNTech and Moderna vaccines utilize mRNA technology to induce an immune response, while the Johnson & Johnson vaccine uses a viral vector approach. Additionally, the Novavax COVID-19 vaccine (NVX-CoV2373) has been approved, which uses a protein subunit method to stimulate immunity. These vaccines have shown efficacy in preventing COVID-19 and have been critical in controlling the pandemic.

What other types of research exist?

Promising alternatives to AZD9838 and AZD6563 include the Moderna-1273 mRNA vaccine, which has shown efficacy in various patient groups, including those with immune-mediated diseases. Additionally, the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, and the monoclonal antibody cocktail ZRC-3308 have demonstrated protective efficacy against multiple SARS-CoV-2 variants.

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Cancer Vaccine

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

Phase 1

Waitlist Available

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

Must not have

Woman who are pregnant, lactating, or of child-bearing potential and not using a contraception or abstinence from at least 4 weeks prior to study vaccination and until at least 6 months after study vaccination

Known or suspected congenital or acquired immunodeficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 12 months post vaccination

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, and if capable of becoming pregnant, I am using effective contraception or practicing abstinence.

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I have a weak immune system due to a condition I was born with or acquired later.

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I was not sick or had an infection the day before or on the day of treatment.

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I do not have an active hepatitis B or C infection.

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I have had myocarditis or pericarditis before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for COVID-19 include vaccines, antiviral drugs, and immune modulators. Vaccines like AZD9838 and AZD6563 work by introducing a component of the virus, such as the spike protein, to the immune system, prompting it to produce antibodies and activate T-cells that can recognize and fight the virus. This preemptive immune response is crucial for COVID-19 patients as it helps prevent severe illness by enabling the body to quickly and effectively combat the virus upon exposure. Antiviral drugs inhibit the replication of the virus within the host cells, while immune modulators help regulate the body's immune response to prevent excessive inflammation. Together, these treatments aim to reduce the severity and duration of the disease, ultimately improving patient outcomes.

Antimicrobial peptides: features, applications and the potential use against covid-19.TLR4 as a therapeutic target for respiratory and neurological complications of SARS-CoV-2.COVID-19 Drug Treatment in China.