A Study of RBI-4000 in Healthy Participants

Stopped early · Phase 1

Conditions studied: Healthy Volunteers

In brief

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).

Key facts

Study ID

NCT06048770

Run by

Replicate Bioscience

People needed

89

Starts

2023-09-01

Expected to finish

2024-07-31

Last updated by the study team

2024-08-06

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.
• 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.
• 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.
• Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule.
• Concomitant or planned administration of antimalarial drugs, including hydroxychloroquine within 30 days of vaccination.
• Current anti-tuberculosis prophylaxis or therapy.
• Pregnant or lactating female participant.
• Female participant planning to become pregnant or planning to discontinue contraceptive precautions.
• Participants with extensive tattoos covering deltoid region on both the arms that would preclude the assessment of local reactogenicity.

Where it is running

• Cordova Research Institute — Miami, Florida, United States
• Velocity Clinical Research — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.