Clinical trial NCT06048770: A Study of RBI-4000 in Healthy Participants
Official title: A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of RBI-4000 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Replicate Bioscience
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to 18 months
measure: Immunogenicity of RBI-4000 Measured by Neutralizing Antibody Titers
timeFrame: Day 1 up to 18 months
Secondary outcomes:
measure: Titer level of Rabies Virus Neutralizing Antibody
timeFrame: Day 1 and up to 18 months
measure: Durability of RBI-4000 Against Rabies Assessed by T-cell Levels
timeFrame: Day 1 and up to 18 months
measure: Rate of RBI-4000 Decay Over Time
timeFrame: Day 1 and up to 18 months
measure: Length of Time Above the Recognized Antibody Correlate of Protection Value
timeFrame: Day 1 and up to 18 months
measure: Lowest Dose of RBI-4000 that Provides Durable (greater than [>] 6 months) Coverage Above the Correlate of Protection
timeFrame: Day 1 and up to 18 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Cordova Research Institute
state: Florida
city: Omaha
country: United States
facility: Velocity Clinical Research
state: Nebraska
Study officials:
References: