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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
Summary
This trial is testing a new rabies vaccine, ChAd155-RG, on healthy adults who have never had a rabies vaccine. It compares this new vaccine to an existing one called RABAVERT. The new vaccine works by using a harmless virus to help the body recognize and fight rabies.
Eligible Conditions
- Rabies
- Rabies Vaccine
- Post-Exposure Prophylaxis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, day 8, day 15, day 22, day 29, day 91, day 181, and day 381
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 8, day 15, day 22, day 29, day 91, day 181, and day 381
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
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 • NCT0401944464%
Headache
64%
Vaccination site pain
57%
Fatigue
43%
Malaise
36%
Feeling of body temperature change
29%
White blood cell count decreased
29%
Myalgia
21%
Nausea
21%
Arthralgia
14%
Neutrophil count decreased
14%
Vaccination site erythema
7%
Haemoglobin decreased
7%
Aspartate aminotransferase increased
7%
Gastroenteritis
7%
Lymphocyte count decreased
7%
Upper respiratory tract infection
7%
Pyrexia
7%
Blood pressure diastolic increased
7%
Blood pressure systolic increased
7%
Platelet count increased
7%
Hypoglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Dose ChAd155-RG
High Dose ChAd155-RG (x1)
High Dose ChAd155-RG (x2)
RABAVERT
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
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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
3,316 Previous Clinical Trials
5,547,698 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of certain medical conditions like autoimmune disease, heart, lung, liver, rheumatologic or kidney problems that could significantly affect your health.You are already involved or planning to participate in another clinical study that involves the use of new drugs, taking blood, or undergoing invasive medical procedures that require anesthesia or tissue removal during this trial.You have had a serious allergic reaction to a vaccine or vaccine products in the past.You have a history of long-term hives.You have a history of nervous system disorders such as paralysis, vertigo, or vision problems.You have been vaccinated for rabies before or have had exposure, infection, or disease related to rabies.You are more likely to come into contact with rabies than the average person in the US.You have previously received a vaccine that uses Adenovirus as a carrier.You have a serious mental health condition that, according to the doctor, would make it difficult for you to take part in the study.You have taken part in a study for a new treatment within the last 3 months or plan to do so during this trial.You currently use alcohol or have a history of using recreational or narcotic drugs that could make it hard for you to follow the study requirements.You are currently using chloroquine or hydroxychloroquine.You have a severe allergy or life-threatening reaction to latex.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B
- Group 2: Arm D
- Group 3: Arm A
- Group 4: Arm C
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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