Investigational COVID-19 Vaccine Trial
Brief description of study
This clinical research trial is being conducted to find out whether the administration of two investigational dMab products (not approved by the US FDA) with an investigational device is safe, tolerated, and can produce enough antibodies in your blood that may indicate the ability to prevent infection of COVID-19.
Detailed description of study
If you agree to join the study, you will be asked to complete research procedures including blood draws, physical exams, vital signs, ECGs and receive the study drug injections.
Participation in the study lasts for approximately 18 months.
The most common risks of participation are injection site reactions (such as redness, pain, inflammation)
We encourage you to be vaccinated against COVID-19. Being vaccinated against COVID-19 will not keep you from participating in this study.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
BMI between 20-30
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Age: Between 18 Years - 60 Years
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Gender: All
- Able to provide consent to participate and having signed an Informed Consent Form (ICF)
- Able and willing to comply with all study procedures
- Body mass index (BMI) between 20 and 30, inclusive
- Screening laboratory within normal limits or have only Grade 0-1 findings
- Normal screening ECG or screening ECG with no clinically significant findings
- Women of child-bearing potential agree to use medically effective contraception or have a partner who is sterile/unable to induce pregnancy from enrollment to 6 months following the last injection
- Sexually active men who are considered sexually fertile must agree to use either a barrier method of contraception during the study, and agree to continue the use for at least 6 months following the last injection, or have a partner who is permanently sterile or is medically unable to become pregnant.
- No history of clinically significant immunosuppressive or autoimmune disease. Individuals with HIV infection who have been virologically suppressed for more than 1 year and with current CD4 cell count entry greater than 500 cells/ul will be allowed into the study.
Updated on
09 Mar 2024.
Study ID: 850355
Pre-Screener
