COVID-19Phase 1ARTEMIS-CNCT06147063
A Randomized Trial Evaluating a mRNA-VLP Vaccine's Immunogenicity and Safety for COVID-19
A Phase 1 study testing AZD9838, Licensed SARS-CoV-2 mRNA vaccine and AZD6563 in people with COVID-19 and SARS-CoV-2 Infection, run by AstraZeneca at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection
- What is being tested?
- AZD9838, Licensed SARS-CoV-2 mRNA vaccine and AZD6563
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Nov 2023to 27 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Research Site
Chicago, Illinois, 60640
Research Site
Long Beach, California, 90815
Research Site
North Charleston, South Carolina, 29405
Research Site
Rolling Hills Estates, California, 90274
Research Site
Wichita, Kansas, 67207
About this study
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)
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.
Read the 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
- Being tested
- AZD9838, Licensed SARS-CoV-2 mRNA vaccine, AZD6563
- Keywords
- COVID-19, Coronavirus, Vaccine, SARS-CoV-2, mRNA vaccine
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9838Biological
Intramuscular (IM) injection.
Licensed SARS-CoV-2 mRNA vaccineBiological
Intramuscular (IM) injection.
AZD6563Biological
Intramuscular (IM) injection.
| Study group | Role | What they receive |
|---|---|---|
| AZ BA.4/5 5µg, 18-64 years | Experimental | Participants received a single intramuscular dose of AZD9838. Receives: Biological: AZD9838 |
| AZ BA.4/5 10µg, 18-64 years | Experimental | Participants received a single intramuscular dose of AZD9838. Receives: Biological: AZD9838 |
| Pfizer XBB.1.5, 18-64 years | Active comparator | Participants received a single intramuscular dose of the Pfizer XBB.1.5 vaccine. Receives: Biological: Licensed SARS-CoV-2 mRNA vaccine |
| AZ XBB.1.5 5µg, 18-64 years | Experimental | Participants received a single intramuscular dose of AZD6563. Receives: Biological: AZD6563 |
| AZ XBB.1.5 10µg, 18-64 years | Experimental | Participants received a single intramuscular dose of AZD6563. Receives: Biological: AZD6563 |
| AZ XBB.1.5 5µg, >=65 years | Experimental | Participants received a single intramuscular dose of AZD6563. Receives: Biological: AZD6563 |
| AZ XBB.1.5 10µg, >=65 years | Experimental | Participants received a single intramuscular dose of AZD6563. Receives: Biological: AZD6563 |
| Pfizer XBB.1.5, >=65 years | Active comparator | Participants received a single intramuscular dose of the Pfizer XBB.1.5 vaccine. Receives: Biological: Licensed SARS-CoV-2 mRNA vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with immediate unsolicited adverse events (AE)
Immediate unsolicited AEs were defined as having an onset within 30 minutes post vaccination.
Measured: Within 30 minutes post vaccination
Number of participants with injection site and systemic solicited adverse reactions (ARs)
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).
Measured: Through 7 days post vaccination
Number of participants with any unsolicited adverse events (AEs)
Unsolicited AEs were any AEs reported in addition to predefined solicited ARs.
Measured: Through 28 days post vaccination
Number of participants with serious adverse events (SAEs), Medically-attended adverse events (MAAEs), and Adverse Events of Special Interest (AESIs)
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.
Measured: Through 12 months post vaccination
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 ancestral strain neutralizing antibodies
Model-adjusted GMTs and 95% CIs for SARS-CoV-2 ancestral strain neutralizing antibodies
Measured: Day 29
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies
Model-adjusted GMTs and 95% CIs for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies
Measured: Day 29
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies
Model-adjusted GMTs and 95% CIs for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies
Measured: Day 29
Geometric mean fold rise (GMFR) for SARS-CoV-2 ancestral strain neutralizing antibodies
GMFR for SARS-CoV-2 ancestral strain neutralizing antibodies
Measured: Day 1 to Day 29
Geometric mean fold rise (GMFR) for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies
GMFR for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies
Measured: Day 1 to Day 29
Geometric mean fold rise (GMFR) for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies
GMFR for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies
Measured: Day 1 to Day 29
Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 ancestral strain
Seroresponse was defined as GMFR >=4 from baseline
Measured: Day 1 to Day 29
Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 Omicron BA.4/5
Seroresponse was defined as GMFR >=4 from baseline
Measured: Day 1 to Day 29
Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 Omicron XBB.1.5
Seroresponse was defined as GMFR >=4 from baseline
Measured: Day 1 to Day 29
Secondary outcomes (28)
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 ancestral strain neutralizing antibodies
Model-adjusted GMTs and 95% CIs for SARS-CoV-2 ancestral strain neutralizing antibodies by visit.
Measured: Day 1 to Day 360
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies
Model-adjusted GMTs and 95% CIs for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies by visit.
Measured: Day 1 to Day 360
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies
Model-adjusted GMTs and 95% CIs for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies by visit.
Measured: Day 1 to Day 360
Geometric mean fold rise (GMFR) for SARS-CoV-2 ancestral strain neutralizing antibodies
GMFR for SARS-CoV-2 ancestral strain neutralizing antibodies by visit.
Measured: Day 1 to Day 360
Geometric mean fold rise (GMFR) for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies
GMFR for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies by visit.
Measured: Day 1 to Day 360
Geometric mean fold rise (GMFR) for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies
GMFR for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies by visit.
Measured: Day 1 to Day 360
Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 ancestral strain
Seroresponse was defined as GMFR >=4 from baseline by visit.
Measured: Day 1 to Day 360
Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 Omicron BA.4/5
Seroresponse was defined as GMFR >=4 from baseline by visit.
Measured: Day 1 to Day 360
Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 Omicron XBB.1.5
Seroresponse was defined as GMFR >=4 from baseline by visit.
Measured: Day 1 to Day 360
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 ancestral strain S protein binding antibodies
Model-adjusted GMTs and 95% CIs for SARS-CoV-2 ancestral strain S protein binding antibodies by visit.
Measured: Day 1 to Day 360
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Beta variant S protein binding antibodies
Model-adjusted GMTs and 95% CIs for SARS-CoV-2 Beta variant S protein binding antibodies by visit.
Measured: Day 1 to Day 360
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Delta variant S protein binding antibodies
Model-adjusted GMTs and 95% CIs for SARS-CoV-2 Delta variant S protein binding antibodies by visit.
Measured: Day 1 to Day 360
Geometric mean titer (GMT) for SARS-CoV-2 Omicron subvariant S protein binding antibodies
GMT for SARS-CoV-2 Omicron subvariant S protein binding antibodies by visit.
Measured: Day 1 to Day 360
Geometric mean fold rise (GMFR) for SARS-CoV-2 ancestral strain S protein binding antibodies
GMFR for SARS-CoV-2 ancestral strain S protein binding antibodies by visit.
Measured: Day 1 to Day 360
Geometric mean fold rise (GMFR) for SARS-CoV-2 Beta variant S protein binding antibodies
GMFR for SARS-CoV-2 Beta variant S protein binding antibodies by visit.
Measured: Day 1 to Day 360
Geometric mean fold rise (GMFR) for SARS-CoV-2 Delta variant S protein binding antibodies
GMFR for SARS-CoV-2 Delta variant S protein binding antibodies by visit.
Measured: Day 1 to Day 360
Geometric mean fold rise (GMFR) for SARS-CoV-2 Omicron subvariant S protein binding antibodies
GMFR for SARS-CoV-2 Omicron subvariant S protein binding antibodies by visit.
Measured: Day 1 to Day 360
Proportion of participants with S protein binding antibody seroresponse against SARS-CoV-2 ancestral strain
Seroresponse was defined as GMFR >=4 from baseline by visit.
Measured: Day 1 to Day 360
Proportion of participants with S protein binding antibody seroresponse against SARS-CoV-2 Beta variant
Seroresponse was defined as GMFR >=4 from baseline by visit.
Measured: Day 1 to Day 360
Proportion of participants with S protein binding antibody seroresponse against SARS-CoV-2 Delta variant
Seroresponse was defined as GMFR >=4 from baseline by visit.
Measured: Day 1 to Day 360
Proportion of participants with S protein binding antibody seroresponse against SARS-CoV-2 Omicron subvariant
Seroresponse was defined as GMFR >=4 from baseline by visit.
Measured: Day 1 to Day 360
Geometric mean response of S-specific CD4+ T-cells expressing Th1 cytokines
Geometric mean response of S-specific T cells by phenotype as measured by an intracellular cytokine staining assay over time.
Measured: Day 1 to Day 180
Geometric mean response of S-specific CD4+ T-cells expressing Th2 cytokines
Geometric mean response of S-specific T cells by phenotype as measured by an intracellular cytokine staining assay over time.
Measured: Day 1 to Day 180
Geometric mean response of S-specific CD8+ T-cells expressing cytokines
Geometric mean response of S-specific T cells by phenotype as measured by an intracellular cytokine staining assay over time.
Measured: Day 1 to Day 180
Incidence of H. pylori anti-ferritin antibodies
Incidence of H. pylori anti-ferritin antibodies.
Measured: Day 1 to Day 360
Titer of H. pylori anti-ferritin antibodies
Titer of H. pylori anti-ferritin antibodies.
Measured: Day 1 to Day 360
Incidence of human anti-ferritin antibodies (light and/or heavy)
Incidence of human anti-ferritin antibodies (light and/or heavy).
Measured: Day 1 to Day 360
Titer of human anti-ferritin antibodies (light and/or heavy)
Incidence of human anti-ferritin antibodies (light and/or heavy).
Measured: Day 1 to Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start27 Nov 2023
- Primary completion30 Apr 2024
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147063
- Sponsor's protocol ID
- D8670C00001
- Acronym
- ARTEMIS-C
- Status last verified
- Aug 2026
- First submitted
- 24 Nov 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 ID
- NCT06147063
- Acronym / sponsor ID
- ARTEMIS-C / D8670C00001
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Keywords
- COVID-19, Coronavirus, Vaccine, SARS-CoV-2, mRNA vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| AZ BA.4/5 5µg, 18-64 years | Experimental | Biological: AZD9838Participants received a single intramuscular dose of AZD9838. |
| AZ BA.4/5 10µg, 18-64 years | Experimental | Biological: AZD9838Participants received a single intramuscular dose of AZD9838. |
| Pfizer XBB.1.5, 18-64 years | Active comparator | Biological: Licensed SARS-CoV-2 mRNA vaccineParticipants received a single intramuscular dose of the Pfizer XBB.1.5 vaccine. |
| AZ XBB.1.5 5µg, 18-64 years | Experimental | Biological: AZD6563Participants received a single intramuscular dose of AZD6563. |
| AZ XBB.1.5 10µg, 18-64 years | Experimental | Biological: AZD6563Participants received a single intramuscular dose of AZD6563. |
| AZ XBB.1.5 5µg, >=65 years | Experimental | Biological: AZD6563Participants received a single intramuscular dose of AZD6563. |
| AZ XBB.1.5 10µg, >=65 years | Experimental | Biological: AZD6563Participants received a single intramuscular dose of AZD6563. |
| Pfizer XBB.1.5, >=65 years | Active comparator | Biological: Licensed SARS-CoV-2 mRNA vaccineParticipants received a single intramuscular dose of the Pfizer XBB.1.5 vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD9838Intramuscular (IM) injection. | Biological | AZ BA.4/5 10µg, 18-64 years, AZ BA.4/5 5µg, 18-64 years |
| Licensed SARS-CoV-2 mRNA vaccineIntramuscular (IM) injection. | Biological | Pfizer XBB.1.5, 18-64 years, Pfizer XBB.1.5, >=65 years |
| AZD6563Intramuscular (IM) injection. | Biological | AZ XBB.1.5 10µg, 18-64 years, AZ XBB.1.5 10µg, >=65 years, AZ XBB.1.5 5µg, 18-64 years, AZ XBB.1.5 5µg, >=65 years |
Primary outcome
Number of participants with immediate unsolicited adverse events (AE)
Time frame: Within 30 minutes post vaccination
Immediate unsolicited AEs were defined as having an onset within 30 minutes post vaccination.
Number of participants with injection site and systemic solicited adverse reactions (ARs)
Time frame: 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).
Number of participants with any unsolicited adverse events (AEs)
Time frame: Through 28 days post vaccination
Unsolicited AEs were any AEs reported in addition to predefined solicited ARs.
Number of participants with serious adverse events (SAEs), Medically-attended adverse events (MAAEs), and Adverse Events of Special Interest (AESIs)
Time frame: 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.
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 ancestral strain neutralizing antibodies
Time frame: Day 29
Model-adjusted GMTs and 95% CIs for SARS-CoV-2 ancestral strain neutralizing antibodies
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies
Time frame: Day 29
Model-adjusted GMTs and 95% CIs for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies
Time frame: Day 29
Model-adjusted GMTs and 95% CIs for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies
Geometric mean fold rise (GMFR) for SARS-CoV-2 ancestral strain neutralizing antibodies
Time frame: Day 1 to Day 29
GMFR for SARS-CoV-2 ancestral strain neutralizing antibodies
Geometric mean fold rise (GMFR) for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies
Time frame: Day 1 to Day 29
GMFR for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies
Geometric mean fold rise (GMFR) for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies
Time frame: Day 1 to Day 29
GMFR for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies
Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 ancestral strain
Time frame: Day 1 to Day 29
Seroresponse was defined as GMFR >=4 from baseline
Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 Omicron BA.4/5
Time frame: Day 1 to Day 29
Seroresponse was defined as GMFR >=4 from baseline
Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 Omicron XBB.1.5
Time frame: Day 1 to Day 29
Seroresponse was defined as GMFR >=4 from baseline
28 secondary outcomes
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 ancestral strain neutralizing antibodies
Time frame: Day 1 to Day 360
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies
Time frame: Day 1 to Day 360
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies
Time frame: Day 1 to Day 360
Geometric mean fold rise (GMFR) for SARS-CoV-2 ancestral strain neutralizing antibodies
Time frame: Day 1 to Day 360
Geometric mean fold rise (GMFR) for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies
Time frame: Day 1 to Day 360
Geometric mean fold rise (GMFR) for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies
Time frame: Day 1 to Day 360
Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 ancestral strain
Time frame: Day 1 to Day 360
Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 Omicron BA.4/5
Time frame: Day 1 to Day 360
Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 Omicron XBB.1.5
Time frame: Day 1 to Day 360
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 ancestral strain S protein binding antibodies
Time frame: Day 1 to Day 360
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Beta variant S protein binding antibodies
Time frame: Day 1 to Day 360
Model-adjusted geometric mean titer (GMT) for SARS-CoV-2 Delta variant S protein binding antibodies
Time frame: Day 1 to Day 360
Geometric mean titer (GMT) for SARS-CoV-2 Omicron subvariant S protein binding antibodies
Time frame: Day 1 to Day 360
Geometric mean fold rise (GMFR) for SARS-CoV-2 ancestral strain S protein binding antibodies
Time frame: Day 1 to Day 360
Geometric mean fold rise (GMFR) for SARS-CoV-2 Beta variant S protein binding antibodies
Time frame: Day 1 to Day 360
Geometric mean fold rise (GMFR) for SARS-CoV-2 Delta variant S protein binding antibodies
Time frame: Day 1 to Day 360
Geometric mean fold rise (GMFR) for SARS-CoV-2 Omicron subvariant S protein binding antibodies
Time frame: Day 1 to Day 360
Proportion of participants with S protein binding antibody seroresponse against SARS-CoV-2 ancestral strain
Time frame: Day 1 to Day 360
Proportion of participants with S protein binding antibody seroresponse against SARS-CoV-2 Beta variant
Time frame: Day 1 to Day 360
Proportion of participants with S protein binding antibody seroresponse against SARS-CoV-2 Delta variant
Time frame: Day 1 to Day 360
Proportion of participants with S protein binding antibody seroresponse against SARS-CoV-2 Omicron subvariant
Time frame: Day 1 to Day 360
Geometric mean response of S-specific CD4+ T-cells expressing Th1 cytokines
Time frame: Day 1 to Day 180
Geometric mean response of S-specific CD4+ T-cells expressing Th2 cytokines
Time frame: Day 1 to Day 180
Geometric mean response of S-specific CD8+ T-cells expressing cytokines
Time frame: Day 1 to Day 180
Incidence of H. pylori anti-ferritin antibodies
Time frame: Day 1 to Day 360
Titer of H. pylori anti-ferritin antibodies
Time frame: Day 1 to Day 360
Incidence of human anti-ferritin antibodies (light and/or heavy)
Time frame: Day 1 to Day 360
Titer of human anti-ferritin antibodies (light and/or heavy)
Time frame: Day 1 to Day 360
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- CSR Synopsis (redacted)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD9838, Licensed SARS-CoV-2 mRNA vaccine and AZD6563 in people with COVID-19 and SARS-CoV-2 Infection, run by AstraZeneca at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with immediate unsolicited adverse events (AE) (time frame: Within 30 minutes post vaccination). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.