A Study of RBI-4000 in Healthy Participants

August 2, 2024 updated by: Replicate Bioscience

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33155
        • Cordova Research Institute
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Velocity Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Multiple Ascending Dose (MAD) Cohorts, Cohort 1: RBI-4000 0.1 mcg
Participants will receive RBI-4000 0.1 micrograms (mcg) via intramuscular injection, once on Day 1 and Day 57.
Biological: RBI-4000
RBI-4000 intramuscular injection.
Experimental: MAD Cohorts, Cohort 2: RBI-4000 1 mcg
Participants will receive RBI-4000 1 mcg via intramuscular injection, once on Day 1 and Day 57.
Biological: RBI-4000
RBI-4000 intramuscular injection.
Experimental: MAD Cohorts, Cohort 3: RBI-4000 10 mcg
Participants will receive RBI-4000 10 mcg via intramuscular injection, single dose on Day 1.
Biological: RBI-4000
RBI-4000 intramuscular injection.
Experimental: MAD Cohorts, Cohort 4: RBI-4000 10 mcg
Participants will receive RBI-4000 ,10 mcg via intramuscular injection, once on Day 1 and Day 57.
Biological: RBI-4000
RBI-4000 intramuscular injection.
Active Comparator: Cohort 5: RabAvert 1 mL
Participants will receive RabAvert 1 milliliter (mL), intramuscular injection, once on Day 1 and Day 8.
Biological: RabAvert
RabAvert intramuscular injection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Day 1 up to 18 months
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.
Day 1 up to 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Titer level of Rabies Virus Neutralizing Antibody
Time Frame: Day 1 and up to 18 months
Day 1 and up to 18 months
Durability of RBI-4000 Against Rabies Assessed by T-cell Levels
Time Frame: Day 1 and up to 18 months
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
Rate of RBI-4000 Decay Over Time
Time Frame: Day 1 and up to 18 months
Day 1 and up to 18 months
Length of Time Above the Recognized Antibody Correlate of Protection Value
Time Frame: Day 1 and up to 18 months
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
Time Frame: Day 1 and up to 18 months
Day 1 and up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Replicate Bioscience

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RBI-4000-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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