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New vaccine aims to shield against multiple coronavirus types

NCT ID NCT07280858

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study tests a new vaccine called GBP511, designed to protect against several sarbecoviruses (a group that includes SARS-CoV-2). About 368 healthy adults will receive one or two doses at different strengths, with or without an adjuvant to boost immune response. The goal is to check safety and how well the vaccine triggers the body's defenses.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GBP511 vaccine (with or without CAS-1 adjuvant)
What this could lead to
If successful, this could lead to a vaccine that protects against multiple sarbecoviruses (like SARS-CoV-2 and related viruses), potentially reducing the need for frequent updates.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 368 participants, so safety and immune response are still being tested. The vaccine may not produce strong enough immunity or could have side effects.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 368 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Inclusion Criteria: Age 1. For Stage 1, participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. For Stage 2, participant must be 18 years of age and older, at the time of signing the informed consent. Type of Participant and Disease Characteristics 2. Participants who are healthy as determined by medical evaluation including medical history, vital signs, physical examination, clinical laboratory tests, and medical judgement of the investigator. 3. Participants who are willing and able to attend all scheduled visits and comply with all study procedures. 4. Body mass index (BMI) within the range of 18.5-32.0 kg/m2 (revised) at screening 5. Participants who received a primary series and at least one booster dose of an authorized COVID-19 vaccine at least 24 weeks prior to the 1st study vaccination. Sex and Contraceptive/Barrier Requirements 6. All participants must agree to be abstinent from heterosexual intercourse or agree to consistently use at least one acceptable method of contraception from at least 4 weeks prior to the 1st study vaccination to 12 weeks after the last study vaccination (See Appendix 10.4 for detailed contraceptive methods). 7. Women of childbearing potential (WOCBP) with a negative urine or serum pregnancy test at screening. \* Female participants who are surgically sterile (e.g., having undergone a full hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal with at least 12 months amenorrhoea not considered to be caused by any other medical condition, are not subject to a pregnancy test. Informed Consent 8. Participants who are capable of giving signed informed consent as described in Appendix 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol before initiation of any trial-specific procedures. Exclusion Criteria: Medical Conditions 1. Any clinically significant respiratory symptoms (e.g., cough, sore throat), febrile illness (tympanic temperature \>38°C), or acute illness within 24 hours prior to the 1st study vaccination. Prospective participants with these conditions cannot be included until 24 hours after resolution. 2. Concurrent or a history of virologically or serologically confirmed SARS-CoV-2 infection, or suspected SARS-CoV-2 infection as determined by the investigator, within 24 weeks prior to the 1st study vaccination. 3. History of virologically or serologically confirmed SARS-CoV-1, or MERS disease. 4. History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease. 5. Any positive test results for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening. 6. History of bleeding disorder or thrombocytopenia which is contraindicating intramuscular vaccination in the investigator's opinion. 7. History of hypersensitivity and severe allergic reaction (e.g., anaphylaxis) to any vaccines or components of the study intervention. 8. History of neurologic diseases (e.g., Guillain-Barre syndrome, myelitis, or encephalomyelitis). 9. History of myocarditis, pericarditis or myopericarditis, as assessed by the investigator, indicating probable or possible myocarditis, pericarditis, or myopericarditis, or demonstrating clinically significant abnormalities that could affect participant safety or the interpretation of study findings. 10. History of malignancy within 1 year prior to first study vaccination, except for cutaneous non-melanoma malignancy, melanoma-in-situ, or cervical carcinoma in situ that have been fully treated with completed follow-up prior to screening. Malignancy considered to carry minimal risk of recurrence may also be permitted at the discretion of the investigator. 11. Significant unstable chronic or acute illness that, in the opinion of the investigator, might pose a health risk to the participant if enrolled, or could interfere with the protocol-specified activities, or interpretation of study results. 12. Any other conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives (e.g., alcohol or drug abuse, neurologic or psychiatric conditions). 13. Female participants who are pregnant or breastfeeding. Prior/Concomitant therapy 14. Receipt of any COVID-19 vaccination including investigational vaccines within 24 weeks prior to the 1st study vaccination or planned receipt at any time during the study period. 15. Receipt of any vaccinations intended to prevent SARS-CoV-1 or MERS, including investigational vaccines. 16. Receipt of any vaccine within 4 weeks prior to the 1st study vaccination or planned receipt of any vaccine through 4 weeks after the last study vaccination, except for influenza vaccination, which may be received at least 2 weeks prior to the 1st study vaccination. 17. Receipt of any immunoglobulins and/or blood-derived products within 12 weeks prior to the 1st study vaccination or planned receipt at any time during the study period. 18. Receipt of immunosuppressive therapy, such as any use of anti-cancer chemotherapy or radiation therapy; or chronic use of systemic corticosteroid (≥10 mg prednisone/day or equivalent more than 14 consecutive days) within 12 weeks prior to the 1st study vaccination and throughout the entire study period. The use of intranasal, inhaled, topical, or intra-articular corticosteroid is permitted. Prior/Concurrent Clinical Study Experience 19. Participation in another clinical study and receipt of study intervention within 4 weeks prior to the 1st study vaccination, or concurrent, planned participation in another clinical study with study intervention during this study period. Other Exclusions 20. Investigators, or study staff who are directly involved in the conduct of this study or supervised by the investigator, and their respective family members. 21. Donation of ≥450mL of blood product within 4 weeks prior to screening, or planned donation of blood product from enrollment through 12 weeks after the last study vaccination.

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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

  • Linear

    Joondalup, Western Australia, 6027, Australia

  • Linear

    Nedlands, Western Australia, 6009, Australia

  • Momentum Clinical Research Darlinghurst

    Sydney, Kent Street, 309, Level 9, Australia

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