Can new vaccines outsmart COVID-19 variants?
NCT ID NCT06147063
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This trial tests two experimental COVID-19 vaccines, AZD9838 and AZD6563, in adults to see if they are safe and trigger a strong immune response. Participants receive a single injection of one of the vaccines or a licensed mRNA vaccine for comparison. The study measures side effects and levels of neutralizing antibodies against the original virus and several Omicron variants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AZD9838 and AZD6563, two experimental COVID-19 vaccines given as a single injection
- What this could lead to
- If successful, these vaccines could offer a new option for boosting immunity against COVID-19, including protection against newer variants.
- What could go wrong
- This is an early-phase trial, so the vaccines may not produce a strong enough immune response or may cause side effects. The results will need confirmation in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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243 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Mar 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Long Beach, California, 90815, United States
-
Research Site
Rolling Hills Estates, California, 90274, United States
-
Research Site
Chicago, Illinois, 60640, United States
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Research Site
Wichita, Kansas, 67207, United States
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Research Site
North Charleston, South Carolina, 29405, United States
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Other studies related to the condition(s) this trial covers.
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