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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

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

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 more

Secondary 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 • NCT04019444

64%

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

Haemoglobin decreased

Aspartate aminotransferase increased

Gastroenteritis

Lymphocyte count decreased

Upper respiratory tract infection

Pyrexia

Blood pressure diastolic increased

Blood pressure systolic increased

Platelet count increased

Hypoglycaemia

100%

80%

60%

40%

20%

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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