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Virus Therapy

ChAd155-RG for Rabies

Phase 1
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 8, day 15, day 22, day 29, day 91, day 181, and day 381
Awards & highlights

Study Summary

This trial is testing a new vaccine for rabies virus in adults to see if it is safe and effective. There are 4 groups of people receiving different dosages of either the new vaccine or a placebo, and the trial will take approximately 48 months to complete.

Eligible Conditions
  • Rabies
  • Rabies Vaccination

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 8, day 15, day 22, day 29, day 91, day 181, and day 381
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 8, day 15, day 22, day 29, day 91, day 181, and day 381 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number and Percentage of Participants With New Onset of a Chronic Medical Condition in Each Treatment Arm and Overall
Number and Percentage of Participants With Serious Adverse Events (SAEs) Considered Study Vaccine-Related in Each Treatment Arm and Overall
Number and Percentage of Participants With Serious Adverse Events (SAEs) in Each Treatment Arm and Overall
+4 more
Secondary outcome measures
Peak Rabies VNA Geometric Mean Titer
Percentage of Participants Seroconverting to Rabies Virus in Each Treatment Arm and Overall
Rabies VNA Geometric Mean Titer

Side effects data

From 2023 Phase 1 trial • 50 Patients • NCT04019444
92%
Vaccination site pain
50%
Fatigue
42%
Headache
33%
Malaise
33%
Myalgia
25%
Vaccination site erythema
25%
Pyrexia
25%
Feeling of body temperature change
25%
Haemoglobin decreased
17%
Platelet count increased
17%
Arthralgia
8%
White blood cell count decreased
8%
Blood pressure systolic increased
8%
Hypotension
8%
Injection site haemorrhage
8%
Nausea
8%
Vaccination site pruritus
8%
Vaccination site induration
8%
Lymphocyte count decreased
8%
White blood cell count increased
8%
Costochondritis
8%
Contusion
8%
Neutrophil count decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
RABAVERT
Low Dose ChAd155-RG
High Dose ChAd155-RG (x2)
High Dose ChAd155-RG (x1)

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm CExperimental Treatment2 Interventions
Two 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
Group II: Arm BExperimental Treatment2 Interventions
One 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)
Group III: Arm AExperimental Treatment2 Interventions
One 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)
Group IV: Arm DActive Control2 Interventions
Three 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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ChAd155-RG
2019
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,272 Previous Clinical Trials
5,485,546 Total Patients Enrolled

Media Library

ChAd155-RG (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04019444 — Phase 1
Rabies Research Study Groups: Arm B, Arm D, Arm A, Arm C
Rabies Clinical Trial 2023: ChAd155-RG Highlights & Side Effects. Trial Name: NCT04019444 — Phase 1
ChAd155-RG (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04019444 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can I partake in this clinical trial?

"This rabies-related study is seeking up to 50 participants aged between 18 and 49. Eligible applicants must have been diagnosed with the virus in order to join this trial."

Answered by AI

Is this investigation open to those aged fifty and beyond?

"This clinical trial is only open to patients aged 18-49. However, there are 13 trials for minors and 11 for the elderly who require medical attention."

Answered by AI

How many patients are participating in this clinical experiment?

"At this juncture, enrollment for this trial is not an option. It was initially posted on September 19th 2019 and most recently updated November 23rd 2022. If you are in search of other studies, 15 rabies trials and 13 ChAd155-RG clinicals are currently accepting participants."

Answered by AI

Is enrollment still possible in this clinical trial?

"Unfortunately, recruitment for this trial has ended. It was first posted on September 19th 2019 and the last update occurred on November 23rd 2022. If you are looking to join a clinical study, there are currently 15 rabies studies accepting participants and 13 ChAd155-RG trials open for enrollment."

Answered by AI

Has the Food and Drug Administration accepted ChAd155-RG for medical use?

"The safety profile of ChAd155-RG is estimated to be a 1 because this pharmaceutical is currently in the initial stages of clinical trials, thus having limited evidence supporting its efficacy and security."

Answered by AI

Can you elaborate on any prior experiments that have included ChAd155-RG?

"Presently, there are 13 ChAd155-RG studies taking place. Of these live trials, 4 have progressed to Phase 3 of the assessment process. Pathum Wan in Bangkok houses many of these investigations but 22 other locations across the world are also running similar experiments with this vaccine candidate."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dosage-Escalation Study of the Safety and Immunogenicity of a Novel Rabies Vaccine ChAd155-RG vs. the Comparator RABAVERT Vaccine in Healthy Adult Subjects
2019. "Dosage-Escalation Study of the Safety and Immunogenicity of a Novel Rabies Vaccine ChAd155-RG vs. the Comparator RABAVERT Vaccine in Healthy Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04019444.
~9 spots leftby May 2025
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