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Tests treatment safety and results for Healthy Participants
Official title A Phase I/II, Dose-finding Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Broadly Protective Sarbecovirus Vaccine (GBP511) in Healthy Adults.
ClinicalTrials.gov ID: NCT07280858
What this study is testing
What is Test Drug 1-1 (GBP511 low dose)?
Test Drug 1-1 (GBP511 low dose) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for healthy participants.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research study is to evaluate the safety of and the body's immune response to single and multiple vaccinations in healthy men and women. We want to find out what effects GBP511 has on you and your health.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Participants who are healthy as determined by medical evaluation including medical history, vital signs, physical examination, clinical laboratory...
- Participants who are willing and able to attend all scheduled visits and comply with all study procedures.
- Body mass index (BMI) within the range of 18.5-32.0 kg/m2 (revised) at screening
- 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...
You likely can't join if
- Medical Conditions
- Any clinically significant respiratory symptoms (e.g., cough, sore throat), febrile illness (tympanic temperature \>38°C), or acute illness within 24...
- Concurrent or a history of virologically or serologically confirmed SARS-CoV-2 infection, or suspected SARS-CoV-2 infection as determined by the...
- History of virologically or serologically confirmed SARS-CoV-1, or MERS disease.
- History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease.
- Any positive test results for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening.
See the full eligibility criteria
Who can join
- 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...
- 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.
- Participants who are willing and able to attend all scheduled visits and comply with all study procedures.
- Body mass index (BMI) within the range of 18.5-32.0 kg/m2 (revised) at screening
- 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
- 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...
- 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...
- 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...
What rules you out
- Medical Conditions
- 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...
- 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.
- History of virologically or serologically confirmed SARS-CoV-1, or MERS disease.
- History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease.
- Any positive test results for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening.
- History of bleeding disorder or thrombocytopenia which is contraindicating intramuscular vaccination in the investigator's opinion.
- History of hypersensitivity and severe allergic reaction (e.g., anaphylaxis) to any vaccines or components of the study intervention.
- History of neurologic diseases (e.g., Guillain-Barre syndrome, myelitis, or encephalomyelitis).
- History of myocarditis, pericarditis or myopericarditis, as assessed by the investigator, indicating probable or possible myocarditis, pericarditis, or myopericarditis, or demonstrating clinically significant...
- 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...
- 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...
- 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).
- Female participants who are pregnant or breastfeeding. Prior/Concomitant therapy
- 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.
- Receipt of any vaccinations intended to prevent SARS-CoV-1 or MERS, including investigational vaccines.
- 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...
- 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.
- 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)...
- 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...
- Investigators, or study staff who are directly involved in the conduct of this study or supervised by the investigator, and their respective family members.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, Kent Street, Australia
- Nedlands, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, Kent Street, Australia; Nedlands, Western Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.