Not provided
Not provided
Not provided
Not provided
Not provided
Strategic business decision (not related to safety, efficacy, or quality)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple Ascending Dose (MAD) Cohorts, Cohort 1: RBI-4000 0.1 mcg | Experimental | Participants will receive RBI-4000 0.1 micrograms (mcg) via intramuscular injection, once on Day 1 and Day 57. |
|
| MAD Cohorts, Cohort 2: RBI-4000 1 mcg | Experimental | Participants will receive RBI-4000 1 mcg via intramuscular injection, once on Day 1 and Day 57. |
|
| MAD Cohorts, Cohort 3: RBI-4000 10 mcg | Experimental | Participants will receive RBI-4000 10 mcg via intramuscular injection, single dose on Day 1. |
|
| MAD Cohorts, Cohort 4: RBI-4000 10 mcg | Experimental | Participants will receive RBI-4000 ,10 mcg via intramuscular injection, once on Day 1 and Day 57. |
|
| Cohort 5: RabAvert 1 mL | Active Comparator | Participants will receive RabAvert 1 milliliter (mL), intramuscular injection, once on Day 1 and Day 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBI-4000 | Biological | RBI-4000 intramuscular injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs and SAEs measured per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA 2007). | Day 1 up to 18 months |
| Immunogenicity of RBI-4000 Measured by Neutralizing Antibody Titers | Measured by neutralizing antibody titers >=0.5 IU/mL. | Day 1 up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Durability of RBI-4000 against rabies assessed by quantifying cytokine-producing T cells by ELISpot and flow cytometry. |
Not provided
Inclusion Criteria:
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:
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
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cordova Research Institute | Miami | Florida | 33155 | United States | ||
| Velocity Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40993199 | Derived | Maine CJ, Picarda G, Miyake-Stoner SJ, Essink B, Somodevilla G, Sparks J, Geall AJ, Wang NS, Goldberg Z, Aliahmad P. Durability of next-generation self-replicating RNA vaccine RBI-4000: a phase 1, randomized open label clinical trial. Commun Med (Lond). 2025 Sep 24;5(1):392. doi: 10.1038/s43856-025-01147-4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| RabAvert | Biological | RabAvert intramuscular injection. |
|
| Day 1 and up to 18 months |
| 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 |
| Omaha |
| Nebraska |
| 68134 |
| United States |