NCT06048770
Terminated
Phase 1
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of RBI-4000 in Healthy Volunteers
Replicate Bioscience2 sites in 1 country89 target enrollmentSeptember 1, 2023
ConditionsHealthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy Volunteers
- Sponsor
- Replicate Bioscience
- Enrollment
- 89
- Locations
- 2
- Primary Endpoint
- Frequency of any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- Status
- Terminated
- Last Updated
- last year
Overview
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).
Investigators
Eligibility Criteria
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\^
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Frequency of any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: 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
Time Frame: Day 1 up to 18 months
Measured by neutralizing antibody titers \>=0.5 IU/mL.
Secondary Outcomes
- 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)
- Rate of RBI-4000 Decay Over Time(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)
- Length of Time Above the Recognized Antibody Correlate of Protection Value(Day 1 and up to 18 months)
Study Sites (2)
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Related News
Replicate Bioscience's Self-Replicating RNA Rabies Vaccine Shows Superior Durability in Phase I Trial- Replicate Bioscience's RBI-4000, a self-replicating RNA rabies vaccine, demonstrated durable immune responses lasting up to 8 months in Phase I trials with 100% of participants retaining detectable antibodies at 6 months.
- The vaccine showed superior durability compared to traditional inactivated rabies vaccines, with antibody half-lives extended by at least 6-fold and protective immunity achieved at doses as low as 0.1 micrograms.
- This represents the first demonstration that an RNA vaccination can elicit protective immunity with comparable or superior durability to approved traditional vaccine platforms.
- The findings, published in Communications Medicine, support further development of RBI-4000 as a next-generation approach to address rabies, which causes 59,000 deaths annually worldwide.Replicate's Single-Dose RNA Rabies Vaccine Shows Promise in Phase I Trial- Phase I trial demonstrates Replicate Bioscience's RBI-4000, a self-replicating RNA vaccine, achieves WHO-established immune threshold for rabies protection with a single dose.
- The vaccine showed comparable efficacy to Bavarian Nordic's RavAvert across all tested doses (0.1mg, 1mg, 10mg) with no serious adverse events reported in 89 healthy volunteers.
- Results published in Nature position RBI-4000 as a potential breakthrough in rabies prevention, particularly significant for addressing the 59,000 annual rabies deaths worldwide.