A Study of RBI-4000 in Healthy Participants
Study Details
Study Description
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 dose of RBI-4000 necessary to elicit the rabies virus neutralizing antibody titer of equal or greater than (>=) 0.5 international unit per milliliter (IU/mL).
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Multiple Ascending Dose (MAD) Cohorts, Cohort 1: RBI-4000 0.1 mcg Participants will receive RBI-4000 0.1 micrograms (mcg) via intramuscular injection, once on Day 1 and Day 57. |
Biological: RBI-4000
RBI-4000 intramuscular injection.
|
Experimental: MAD Cohorts, Cohort 2: RBI-4000 1 mcg Participants will receive RBI-4000 1 mcg via intramuscular injection, once on Day 1 and Day 57. |
Biological: RBI-4000
RBI-4000 intramuscular injection.
|
Experimental: MAD Cohorts, Cohort 3: RBI-4000 10 mcg Participants will receive RBI-4000 10 mcg via intramuscular injection, single dose on Day 1. |
Biological: RBI-4000
RBI-4000 intramuscular injection.
|
Experimental: MAD Cohorts, Cohort 4: RBI-4000 10 mcg Participants will receive RBI-4000 ,10 mcg via intramuscular injection, once on Day 1 and Day 57. |
Biological: RBI-4000
RBI-4000 intramuscular injection.
|
Active Comparator: Cohort 5: RabAvert 1 mL Participants will receive RabAvert 1 milliliter (mL), intramuscular injection, once on Day 1 and Day 8. |
Biological: RabAvert
RabAvert intramuscular injection.
|
Outcome Measures
Primary Outcome Measures
- Frequency of any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Day 1 up to 18 months]
TEAEs and SAEs measured per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA 2007).
- Immunogenicity of RBI-4000 Measured by Neutralizing Antibody Titers [Day 1 up to 18 months]
Measured by neutralizing antibody titers >=0.5 IU/mL.
Secondary Outcome Measures
- Titer level of Rabies Virus Neutralizing Antibody [Day 1 and up to 18 months]
- Durability of RBI-4000 Against Rabies Assessed by T-cell Levels [Day 1 and up to 18 months]
Durability of RBI-4000 against rabies assessed by quantifying cytokine-producing T cells by ELISpot and flow cytometry.
- Rate of RBI-4000 Decay Over Time [Day 1 and up to 18 months]
- Length of Time Above the Recognized Antibody Correlate of Protection Value [Day 1 and up to 18 months]
- Lowest Dose of RBI-4000 that Provides Durable (greater than [>] 6 months) Coverage Above the Correlate of Protection [Day 1 and up to 18 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Any gender participants between 18 and 45 years old, inclusive, at the time of the first vaccination.
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Body Mass Index >18 kilogram per square meter (Kg/m2) and less than (<) 32 Kg/m2.
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Hematological/biochemical values within these parameters:
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White Blood Cells and differential, within the study designated laboratory normal range.
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Platelets = 125,000 - 500,000 cells per cubic millimeter (cells/mm^3)
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Hemoglobin within normal range of the study designated laboratory
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Liver function tests including alanine aminotransferase, aspartate aminotransferase, total bilirubin, and alkaline phosphatase within the study designated laboratory normal range.
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Female participants of non-childbearing potential or male participants with partners of childbearing potential may be enrolled in the study.
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Female participants of childbearing potential may be enrolled in the study, if the participant
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has practiced adequate contraception for 30 days prior to vaccination, and
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has a negative pregnancy test on the day of vaccination (for female participants),
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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 Criteria:
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History of diagnosis with rabies exposure, infection or disease.
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History of rabies immunization (licensed or investigational) or human rabies immune globulin.
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Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
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Family history of congenital or hereditary immunodeficiency.
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History of or current autoimmune disease.
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History of any reaction or hypersensitivity likely to be exacerbated by any components of commercially available rabies vaccines.
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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).
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History of Type I hypersensitivity reactions to any beta-lactam antibiotics.
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Any acute or chronic, clinically significant disease, by history, physical examination, laboratory findings, subject personal report, and/or General Physician information.
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Any history of myocarditis and/or pericarditis.
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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.
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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.
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Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule.
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Concomitant or planned administration of antimalarial drugs, including hydroxychloroquine within 30 days of vaccination.
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Current anti-tuberculosis prophylaxis or therapy.
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Pregnant or lactating female participant.
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Female participant planning to become pregnant or planning to discontinue contraceptive precautions.
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Participants with extensive tattoos covering deltoid region on both the arms that would preclude the assessment of local reactogenicity.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cordova Research Institute | Miami | Florida | United States | 33155 |
2 | Velocity Clinical Research | Omaha | Nebraska | United States | 68134 |
Sponsors and Collaborators
- Replicate Bioscience
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RBI-4000-101