ChAd155-RG for Rabies

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Emory Vaccine Center - The Hope Clinic, Decatur, GA
Rabies+1 More
ChAd155-RG - Biological
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new vaccine may be effective for preventing rabies.

See full description

Eligible Conditions

  • Rabies
  • Rabies Immunisation

Treatment Effectiveness

Study Objectives

This trial is evaluating whether ChAd155-RG will improve 13 primary outcomes and 3 secondary outcomes in patients with Rabies. Measurement will happen over the course of Day 1 through Day 22.

Day 22
Frequency of study vaccine-related lab Adverse Events (AEs)
Severity of study vaccine-related lab Adverse Events (AEs)
Day 29
Frequency of solicited injection site events
Frequency of systemic reactogenicity events
Severity of solicited injection site events
Severity of systemic reactogenicity events
Day 381
Frequency of Serious Adverse Events (SAEs) considered study vaccine-related
Frequency of any Serious Adverse Events (SAEs)
Geometric Mean Titer (GMT) (as measured by rabies VNA using a standard, WHO-approved, RFFIT)
Number of subjects with new onset of a chronic medical condition
Peak Geometric Mean Titer (GMT) (defined as highest GMT measured across all post-vaccination antibody time points)
Proportion of subjects seroconverting to rabies virus (defined as VNA concentration > / = 0.5 IU/mL)
Severity of Serious Adverse Events (SAEs) considered study vaccine-related
Severity of any Serious Adverse Events (SAEs)
Day 50
Frequency of unsolicited study vaccine-related Adverse Events (AEs)
Severity of unsolicited study vaccine-related Adverse Events (AEs)

Trial Safety

Trial Design

4 Treatment Groups

Arm D
1 of 4
Arm A
1 of 4
Arm B
1 of 4
Arm C
1 of 4
Active Control
Experimental Treatment

This trial requires 43 total participants across 4 different treatment groups

This trial involves 4 different treatments. ChAd155-RG is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Arm AOne dose (1 ml (5x10^10 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, 22. N=14 (3 sentinel, 11 non-sentinel)
Arm BOne dose (1 ml (1x10^11 vp)) of ChAd155-RG vaccine administered intramuscularly on Day 1, and 1 ml of matching placebo administered intramuscularly on Days 8, 15, 22. N=14 (3 sentinel, 11 non-sentinel)
Arm CTwo doses (1 ml (1x10^11 vp) each) of ChAd155-RG vaccine administered intramuscularly on Day 1 (first dose) and Day 15 (second dose), and 1 ml of matching placebo administered intramuscularly on Days 8 and 22. N=10
Arm DThree doses (1 ml each) of RABAVERT vaccine administered intramuscularly on Day 1 (first dose), Day 8 (second dose), and Day 22 (third dose), and 1 ml of matching placebo administered intramuscularly on Day 15. N=12 (2 sentinel, 10 non-sentinel)

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 through day 381
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 1 through day 381 for reporting.

Closest Location

Emory Vaccine Center - The Hope Clinic - Decatur, GA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Must be a male or female aged 18-49 years old (inclusive) at the time of first vaccination.
Must be able to provide written informed consent.
Must have a body mass index (BMI) = / >18.5 and <35.0 kg/m^2
Must be in good health based on physical examination, vital signs*, medical history, safety labs**, and the investigator's clinical judgment.
*Vital signs must be within the normal ranges. If a subject has elevated systolic or diastolic blood pressure, subject may rest for 10 minutes in a quiet room and the blood pressure may be retaken.
**Safety lab normal ranges will be those used by the reference clinical lab. Protocol-specific criteria for individual subjects are listed in criteria #5.
Hemoglobin: women >11.6 g/dL, men >13.1 g/dL
White blood cells: >3,700 but <10,900 cells/mm^3
Absolute neutrophil count: = / >1,500 cells/mm^3
Absolute lymphocyte count: = / >850 cells/mm^3

Patient Q&A Section

What is rabies?

"Rabies is a deadly disease that kills over a million people annually and is caused by a virus that is transmitted by a bite from a bite infected animal. In the United States, rabid animals are most commonly skunks, stray cats and raccoons.\n" - Anonymous Online Contributor

Unverified Answer

What causes rabies?

"The rabies virus lives in the saliva of infected animals and is a potential means of transmission of the disease. Transmission can occur by bites or saliva transmission.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for rabies?

"Of the six therapies described, only nerve grafting and nerve graft plus antiviral therapy resulted in survival. Nerve grafting was the only therapy to result in full recovery. Nerve grafting, which has been shown to be effective in some other species, and the antiviral therapy may, by analogy, be considered first-line therapies to treat rabies." - Anonymous Online Contributor

Unverified Answer

How many people get rabies a year in the United States?

"An estimated 2,500 deaths have been associated with rabies annually in the United States. Rabies is most commonly contracted through a bite from an infected animal. Most cases occur in children from the age of 4 to 10 years old. The number of cases of human rabies in the United States is decreasing, probably due to public education and increased awareness of rabies. This article demonstrates the steps a community can take to prevent rabies through rabies vaccination programs." - Anonymous Online Contributor

Unverified Answer

Can rabies be cured?

"Rabies can be easily, safely, and quickly eradicated by a human antibody. Rabies was eradicated from a domestic cat in as little as 24 hours. This should be expected to occur in all patients treated with an experimental rabies treatment in clinical trials of a human rabies vaccine. Rabies can be quickly, safely, and successfully eradicated by a neutralizing human monoclonal antibody, once the rabies virus is in the process of entering into the central nervous system." - Anonymous Online Contributor

Unverified Answer

What are the signs of rabies?

"The symptoms of rabies are a combination of the symptoms of other diseases with rabies. The initial symptoms after exposure to the infectious agent are generally nonspecific. Fever, headache, chills, and malaise are common, but a headache more often persists than others. Later, a series of neurological symptoms develops. These may precede, follow, or be concomitant with the onset of skin signs. Other symptoms may develop in isolation. The pattern of neurological involvement in rabies may vary. Different features such as the signs and symptoms of stroke are associated with stroke, stroke in association with encephalitis or meningitis due to infectious causes, or in the presence of an underlying infection." - Anonymous Online Contributor

Unverified Answer

Does rabies run in families?

"Recent findings of the current study add further credence to the hypothesis of a genetic basis for rabies transmission. The family histories may be the result of selection among the first generation of families or of genetic drift." - Anonymous Online Contributor

Unverified Answer

Has chad155-rg proven to be more effective than a placebo?

"These data show that the live vaccinia/rabies vaccine is more effective than a placebo and can be used in combination with chemotherapy to enhance the effect of the rabies vaccine. Although the treatment regimen has not yet been tested, we feel it is justified to use this vaccination in symptomatic people and those with a very high risk of rabies exposure." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving chad155-rg?

"Chad155-rg is one of the lead candidate antigens selected for developing a vaccine against rabies. This phase I trial provides preliminary evidence that the protocol is safe and feasible in healthy human volunteers. The potential for the vaccine to protect against rabies is also under evaluation. In conjunction with additional preclinical studies, this trial may enable development of a recombinant rabies vaccine that is both effective for prevention of rabies and suitable for use in developing countries without access to modern diagnostic tools. (https://clinicaltrials.gov/ct/show/NCT00251278) ClinicalTrials.gov, National Institutes of Health, Bethesda, MD." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in chad155-rg for therapeutic use?

"This is the first report of the successful and long term survival of two of our patients who received chad155-rg-therapeutic infusions. Chad155-rg may be a therapeutic option to prevent and manage rabies in the patient population currently unprotected." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of rabies?

"In the context of a rabies serosurvey, the presence of other diseases that can cause similar clinical profiles is an important issue. Data from a recent study indicates the need for more comprehensive education, which aims to identify the right diagnosis to provide care early." - Anonymous Online Contributor

Unverified Answer

How serious can rabies be?

"Rabics patients often do not make it to a hospital. A full spectrum of rabics treatment should be performed early in the course of their illness: [treatment with a monoclonal antibody; dosing of high dose cortics and antitransfusion [blood-transfusion]; dosing of supportive therapies such as vasopressors, diuretics, and inotropes (e.g." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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