A Study of RBI-4000 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of RBI-4000 in Healthy Volunteers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06048770
• Other study ID #: RBI-4000-101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 1, 2023
• Est. completion date: April 14, 2025

Study information

• Verified date: March 2024
• Source: Replicate Bioscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: April 14, 2025
• Est. primary completion date: April 14, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Any gender participants between 18 and 45 years old, inclusive, at the time of the first vaccination.

2. Body Mass Index >18 kilogram per square meter (Kg/m^2) and less than (<) 32 Kg/m^2.

3. Hematological/biochemical values within these parameters:

1. White Blood Cells and differential, within the study designated laboratory normal range.

2. Platelets = 125,000 - 500,000 cells per cubic millimeter (cells/mm^3)

3. Hemoglobin within normal range of the study designated laboratory

4. Liver function tests including alanine aminotransferase, aspartate aminotransferase, total bilirubin, and alkaline phosphatase within the study designated laboratory normal range.

4. Female participants of non-childbearing potential or male participants with partners of childbearing potential may be enrolled in the study.

5. Female participants of childbearing potential may be enrolled in the study, if the participant

1. has practiced adequate contraception for 30 days prior to vaccination, and

2. has a negative pregnancy test on the day of vaccination (for female participants),

3. 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:

1. History of diagnosis with rabies exposure, infection or disease.

2. History of rabies immunization (licensed or investigational) or human rabies immune globulin.

3. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.

4. Family history of congenital or hereditary immunodeficiency.

5. History of or current autoimmune disease.

6. History of any reaction or hypersensitivity likely to be exacerbated by any components of commercially available rabies vaccines.

7. 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).

8. History of Type I hypersensitivity reactions to any beta-lactam antibiotics.

9. Any acute or chronic, clinically significant disease, by history, physical examination, laboratory findings, subject personal report, and/or General Physician information.

10. Any history of myocarditis and/or pericarditis.

11. 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.

12. 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.

13. Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule.

14. Concomitant or planned administration of antimalarial drugs, including hydroxychloroquine within 30 days of vaccination.

15. Current anti-tuberculosis prophylaxis or therapy.

16. Pregnant or lactating female participant.

17. Female participant planning to become pregnant or planning to discontinue contraceptive precautions.

18. Participants with extensive tattoos covering deltoid region on both the arms that would preclude the assessment of local reactogenicity.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Biological:
• RBI-4000
RBI-4000 intramuscular injection.
• RabAvert
RabAvert intramuscular injection.

Locations

Country	Name	City	State
United States	Cordova Research Institute	Miami	Florida
United States	Velocity Clinical Research	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Replicate Bioscience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Immunogenicity of RBI-4000 Measured by Neutralizing Antibody Titers	Measured by neutralizing antibody titers >=0.5 IU/mL.	Day 1 up to 18 months
Secondary	Titer level of Rabies Virus Neutralizing Antibody		Day 1 and up to 18 months
Secondary	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.	Day 1 and up to 18 months
Secondary	Rate of RBI-4000 Decay Over Time		Day 1 and up to 18 months
Secondary	Length of Time Above the Recognized Antibody Correlate of Protection Value		Day 1 and up to 18 months
Secondary	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