NCT06147063

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

A Phase I, Open-label, Randomized, Active-Controlled Study in Adults to Characterize the Safety and Immunogenicity of AZD9838 and AZD6563 Vaccine (ARTEMIS-C)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to characterize the safety and immunogenicity of AZD9838 and AZD6563 when administered as a single dose vaccination against SARS-CoV-2 in adults.

Detailed description

This is a Phase I, open-label, randomized, active-controlled study to assess the safety and immunogenicity of 2 dosages of AZD9838 and 2 dosages of AZD6563 compared with a licensed SARS-CoV-2 mRNA vaccine in approximately 240 healthy participants. AZD6563 will be assessed in adults 18 years of age and older. AZD9838 will be assessed in adults 18 to 64 years of age only. The duration of each participant's involvement in the study will be approximately 12 months following administration of study vaccination.

Conditions

• COVID-19
• SARS-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	AZD9838	Intramuscular (IM) injection.
BIOLOGICAL	Licensed mRNA vaccine	Intramuscular (IM) injection.
BIOLOGICAL	AZD6563	Intramuscular (IM) injection.

Timeline

• Start date: 2023-11-27
• Primary completion: 2024-04-30
• Completion: 2025-03-27
• First posted: 2023-11-27
• Last updated: 2025-06-29

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study