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

NCT06147063
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Completed
clinicaltrials.gov
Participants
243
clinicaltrials.gov
Lead sponsor
AstraZeneca
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Start date
2023-11-27
clinicaltrials.gov
Number of sites
5
clinicaltrials.gov

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.
clinicaltrials.gov
Acronym
ARTEMIS-C
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Short title
A Randomized Trial Evaluating a mRNA-VLP Vaccine's Immunogenicity and Safety for COVID-19
clinicaltrials.gov
Official title
A Phase I, Open-label, Randomized, Active-Controlled Study in Adults to Characterize the Safety and Immunogenicity of AZD9838 and AZD6563 Vaccine (ARTEMIS-C)
clinicaltrials.gov

Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2025-03-27
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First posted
2023-11-27
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Registry last updated
2026-08-31
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Primary completion date
2024-04-30
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Start date
2023-11-27
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Actual participants
243
clinicaltrials.gov
Participants
243
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
5
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06147063
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ClinicalTrials.gov ID
NCT06147063
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of participants with immediate unsolicited adverse events (AE)

    Timeframe: Within 30 minutes post vaccination

    Immediate unsolicited AEs were defined as having an onset within 30 minutes post vaccination.

  2. Number of participants with injection site and systemic solicited adverse reactions (ARs)

    Timeframe: Through 7 days post vaccination

    Injection site solicited ARs included injection site pain, injection site erythema (redness), and injection site swelling. Systemic solicited ARs included fever, chills, headache, myalgia (muscle aches and pains), and fatigue (physical or mental tiredness).

  3. Number of participants with any unsolicited adverse events (AEs)

    Timeframe: Through 28 days post vaccination

    Unsolicited AEs were any AEs reported in addition to predefined solicited ARs.

  4. Number of participants with serious adverse events (SAEs), Medically-attended adverse events (MAAEs), and Adverse Events of Special Interest (AESIs)

    Timeframe: Through 12 months post vaccination

    An SAE is an AE meeting one or more of: resulted in death; was immediately life-threatening; required or prolonged in-patient hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or was an important medical event that may have jeopardized the participant or required intervention to prevent the above. MAAEs are AEs leading to medically attended visits that were not routine physical examination or vaccination visits (eg, urgent care, emergency room, or unscheduled visits to/from medical personnel, including telemedicine). An AESI was an event of scientific and medical interest, specific to understanding the safety profile of the investigational vaccine, requiring close monitoring and rapid communication by Investigators to the Sponsor.

  5. Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 ancestral strain neutralizing antibodies

    Timeframe: Day 29

    Model-adjusted GMTs and 95% CIs for SARS-CoV-2 ancestral strain neutralizing antibodies

  6. Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies

    Timeframe: Day 29

    Model-adjusted GMTs and 95% CIs for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies

  7. Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies

    Timeframe: Day 29

    Model-adjusted GMTs and 95% CIs for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies

  8. Geometric mean fold rise (GMFR) for SARS-CoV-2 ancestral strain neutralizing antibodies

    Timeframe: Day 1 to Day 29

    GMFR for SARS-CoV-2 ancestral strain neutralizing antibodies

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

    Timeframe: Day 1 to Day 29

    GMFR for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies

  10. Geometric mean fold rise (GMFR) for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies

    Timeframe: Day 1 to Day 29

    GMFR for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies

  11. Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 ancestral strain

    Timeframe: Day 1 to Day 29

    Seroresponse was defined as GMFR \>=4 from baseline

  12. Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 Omicron BA.4/5

    Timeframe: Day 1 to Day 29

    Seroresponse was defined as GMFR \>=4 from baseline

  13. Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 Omicron XBB.1.5

    Timeframe: Day 1 to Day 29

    Seroresponse was defined as GMFR \>=4 from baseline

  1. Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 ancestral strain neutralizing antibodies

    Timeframe: Day 1 to Day 360

    Model-adjusted GMTs and 95% CIs for SARS-CoV-2 ancestral strain neutralizing antibodies by visit.

  2. Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies

    Timeframe: Day 1 to Day 360

    Model-adjusted GMTs and 95% CIs for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies by visit.

  3. Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies

    Timeframe: Day 1 to Day 360

    Model-adjusted GMTs and 95% CIs for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies by visit.

  4. Geometric mean fold rise (GMFR) for SARS-CoV-2 ancestral strain neutralizing antibodies

    Timeframe: Day 1 to Day 360

    GMFR for SARS-CoV-2 ancestral strain neutralizing antibodies by visit.

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

    Timeframe: Day 1 to Day 360

    GMFR for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies by visit.

  6. Geometric mean fold rise (GMFR) for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies

    Timeframe: Day 1 to Day 360

    GMFR for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies by visit.

  7. Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 ancestral strain

    Timeframe: Day 1 to Day 360

    Seroresponse was defined as GMFR \>=4 from baseline by visit.

  8. Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 Omicron BA.4/5

    Timeframe: Day 1 to Day 360

    Seroresponse was defined as GMFR \>=4 from baseline by visit.

  9. Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 Omicron XBB.1.5

    Timeframe: Day 1 to Day 360

    Seroresponse was defined as GMFR \>=4 from baseline by visit.

  10. Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 ancestral strain S protein binding antibodies

    Timeframe: Day 1 to Day 360

    Model-adjusted GMTs and 95% CIs for SARS-CoV-2 ancestral strain S protein binding antibodies by visit.

  11. Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Beta variant S protein binding antibodies

    Timeframe: Day 1 to Day 360

    Model-adjusted GMTs and 95% CIs for SARS-CoV-2 Beta variant S protein binding antibodies by visit.

  12. Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Delta variant S protein binding antibodies

    Timeframe: Day 1 to Day 360

    Model-adjusted GMTs and 95% CIs for SARS-CoV-2 Delta variant S protein binding antibodies by visit.

  13. Geometric mean titer (GMT) for SARS-CoV-2 Omicron subvariant S protein binding antibodies

    Timeframe: Day 1 to Day 360

    GMT for SARS-CoV-2 Omicron subvariant S protein binding antibodies by visit.

  14. Geometric mean fold rise (GMFR) for SARS-CoV-2 ancestral strain S protein binding antibodies

    Timeframe: Day 1 to Day 360

    GMFR for SARS-CoV-2 ancestral strain S protein binding antibodies by visit.

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

    Timeframe: Day 1 to Day 360

    GMFR for SARS-CoV-2 Beta variant S protein binding antibodies by visit.

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

    Timeframe: Day 1 to Day 360

    GMFR for SARS-CoV-2 Delta variant S protein binding antibodies by visit.

  17. Geometric mean fold rise (GMFR) for SARS-CoV-2 Omicron subvariant S protein binding antibodies

    Timeframe: Day 1 to Day 360

    GMFR for SARS-CoV-2 Omicron subvariant S protein binding antibodies by visit.

  18. Proportion of participants with S protein binding antibody seroresponse against SARS-CoV-2 ancestral strain

    Timeframe: Day 1 to Day 360

    Seroresponse was defined as GMFR \>=4 from baseline by visit.

  19. Proportion of participants with S protein binding antibody seroresponse against SARS-CoV-2 Beta variant

    Timeframe: Day 1 to Day 360

    Seroresponse was defined as GMFR \>=4 from baseline by visit.

  20. Proportion of participants with S protein binding antibody seroresponse against SARS-CoV-2 Delta variant

    Timeframe: Day 1 to Day 360

    Seroresponse was defined as GMFR \>=4 from baseline by visit.

  21. Proportion of participants with S protein binding antibody seroresponse against SARS-CoV-2 Omicron subvariant

    Timeframe: Day 1 to Day 360

    Seroresponse was defined as GMFR \>=4 from baseline by visit.

  22. Geometric mean response of S-specific CD4+ T-cells expressing Th1 cytokines

    Timeframe: Day 1 to Day 180

    Geometric mean response of S-specific T cells by phenotype as measured by an intracellular cytokine staining assay over time.

  23. Geometric mean response of S-specific CD4+ T-cells expressing Th2 cytokines

    Timeframe: Day 1 to Day 180

    Geometric mean response of S-specific T cells by phenotype as measured by an intracellular cytokine staining assay over time.

  24. Geometric mean response of S-specific CD8+ T-cells expressing cytokines

    Timeframe: Day 1 to Day 180

    Geometric mean response of S-specific T cells by phenotype as measured by an intracellular cytokine staining assay over time.

  25. Incidence of H. pylori anti-ferritin antibodies

    Timeframe: Day 1 to Day 360

    Incidence of H. pylori anti-ferritin antibodies.

And 3 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

Key Inclusion Criteria:

  • Adults ≥ 18 years at the time of signing informed consent.
  • Self-reported History of SARS-CoV-2 infection at least 6 months prior to study vaccination AND/OR prior completion of primary series vaccination against COVID-19, with the final dose received at least 6 months prior to study vaccination
  • Negative SARS-CoV-2 RT-PCR test at Visit 1
  • Body mass index (BMI) of <35 kg/m2 at screening
  • 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.

Key Exclusion Criteria:

  • Acute illness/infection on day prior or day of dosing
  • History of hypersensitivity to any component of the study vaccination, severe adverse reaction associated with a vaccine and/or severe allergic reaction
  • Positive COVID-19 test result within 6 months of Visit 1
  • Receipt of licensed, authorized, or investigational COVID-19 vaccines in the 6 months prior to administration of study intervention or expected receipt through completion of Visit 5.
  • Receipt of any COVID-19 monoclonal antibody (licensed or investigational) within 3 months or receipt of immunoglobulin (non-COVID related) or blood products within 6 months prior to administration of study intervention, or expected receipt during the study
  • Receipt of any licensed or investigational vaccine (other than licensed influenza vaccines or non-study COVID-19 vaccines) within 30 days prior to Visit 1 or expected receipt prior to completion of Visit 4. Licensed influenza vaccines are permitted beginning > 14 days before and > 14 days after administration of study intervention.
  • Previous history of myocarditis or pericarditis
  • 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
  • Lab values above ULN (Serum creatinine, AST, ALT), below LLN (hemoglobin, WBC, Platelet count) or any lab value that in the opinion of the investigator is clinically significant or might confound analysis of the study results. Participants with laboratory values outside of the normal range may have the abnormal test repeated within the screening window and if the values are normal, then the participant can be randomized. If the repeated value remains outside of the normal range but it is not felt to be clinically significant by the Investigator, the case can be discussed with the AstraZeneca study physician and if they both agree the value is not clinically significant, the participant can be randomized
  • History of malignancy within 5 years (treated non-melanoma skin cancer and locally treated cervical cancers allowed)
  • Known or suspected congenital or acquired immunodeficiency
  • Known or suspected autoimmune conditions as determined by history and /or physical examination
  • Active infection with hepatitis B or C
  • Troponin I levels above the normal range at the screening visit
  • History of hypersensitivity to kanamycin or any aminoglycoside antibiotics (eg, neomycin, streptomycin, tobramycin, and gentamicin).
Sources for eligibility
clinicaltrials.gov

  • Research SiteLong Beach, United States
  • Research SiteRolling Hills Estates, United States
  • Research SiteChicago, United States
  • Research SiteWichita, United States
  • Research SiteNorth Charleston, United States
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)