Status:
TERMINATED
A Study of RBI-4000 in Healthy Participants
Lead Sponsor:
Replicate Bioscience
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The primary purpose of the study is to evaluate the safety, reactogenicity, and immunogenicity of RBI-4000 administered at various dose levels via intramuscular injection and to determine the lowest d...
Eligibility Criteria
Inclusion
- Any gender participants between 18 and 45 years old, inclusive, at the time of the first vaccination.
- Body Mass Index \>18 kilogram per square meter (Kg/m\^2) and less than (\<) 32 Kg/m\^2.
- Hematological/biochemical values within these parameters:
- White Blood Cells and differential, within the study designated laboratory normal range.
- Platelets = 125,000 - 500,000 cells per cubic millimeter (cells/mm\^3)
- Hemoglobin within normal range of the study designated laboratory
- Liver function tests including alanine aminotransferase, aspartate aminotransferase, total bilirubin, and alkaline phosphatase within the study designated laboratory normal range.
- Female participants of non-childbearing potential or male participants with partners of childbearing potential may be enrolled in the study.
- Female participants of childbearing potential may be enrolled in the study, if the participant
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination (for female participants),
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series and agrees to not donate sperm (for male participants).
Exclusion
- History of diagnosis with rabies exposure, infection or disease.
- History of rabies immunization (licensed or investigational) or human rabies immune globulin.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
- History of or current autoimmune disease.
- History of any reaction or hypersensitivity likely to be exacerbated by any components of commercially available rabies vaccines.
- Lymphoproliferative disorder or malignancy within previous 5 years (excluding effectively treated non-melanotic skin cancer, Ductal carcinoma in situ /Lobular carcinoma in situ (DCIS/LCIS).
- History of Type I hypersensitivity reactions to any beta-lactam antibiotics.
- Any acute or chronic, clinically significant disease, by history, physical examination, laboratory findings, subject personal report, and/or General Physician information.
- Any history of myocarditis and/or pericarditis.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs including steroids during the period within 6 months prior to the vaccine dose.
- Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule.
- Concomitant or planned administration of antimalarial drugs, including hydroxychloroquine within 30 days of vaccination.
- Current anti-tuberculosis prophylaxis or therapy.
- Pregnant or lactating female participant.
- Female participant planning to become pregnant or planning to discontinue contraceptive precautions.
- Participants with extensive tattoos covering deltoid region on both the arms that would preclude the assessment of local reactogenicity.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT06048770
Start Date
September 1 2023
End Date
July 31 2024
Last Update
August 6 2024
Active Locations (2)
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1
Cordova Research Institute
Miami, Florida, United States, 33155
2
Velocity Clinical Research
Omaha, Nebraska, United States, 68134