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Virus Therapy

Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A) for Central Nervous System Viral Infection

Phase 1
Waitlist Available
Research Sponsored by GlaxoSmithKline
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 at month 7 (i.e. 5 months after the last vaccination)

Summary

This trial is testing a new rabies vaccine in healthy adults to see if it is safe and effective. The vaccine works by introducing a protein from the rabies virus to help the immune system recognize and fight the virus. Over two-thirds of the world's population lives in regions where rabies is common, resulting in over 15 million people receiving treatment after exposure and over 55,000 deaths per year globally.

Eligible Conditions
  • Central Nervous System Viral Infection
  • Viral Diseases

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 7 (i.e. 5 months after the last vaccination)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 7 (i.e. 5 months after the last vaccination) 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 of participants reporting medically attended AE (MAEs)
Number of participants reporting potential immune-mediated diseases (pIMDs)
Number of participants reporting serious adverse events (SAEs)
+12 more
Secondary study objectives
Evaluation of immunogenicity in terms of Anti-rabies G IgG antibody concentrations
Evaluation of immunogenicity in terms of Rabies Virus Neutralizing Antibody (RVNA) concentrations
Evaluation of persistence of immunogenicity in terms of anti-rabies G IgG antibody concentrations at 10 months after last vaccination
+8 more

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Medium dose (Md-) RG SAM (CNE) groupExperimental Treatment1 Intervention
Healthy adults,18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) medium dose formulation vaccine in one arm and one intramuscular injection of saline solution in the opposite arm at Day 1.
Group II: Lowest dose (Ltd-) RG SAM (CNE) groupExperimental Treatment1 Intervention
Healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) lowest dose formulation vaccine in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61)
Group III: Lower dose (Lrd-) RG SAM (CNE) groupExperimental Treatment1 Intervention
Healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) lower dose formulation vaccine in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61)
Group IV: Low dose (Ld-) RG SAM (CNE) groupExperimental Treatment1 Intervention
In Part 1 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) low dose formulation vaccine in one arm and one intramuscular injection of saline solution in the opposite arm at Days 1 and 61). In Part 2 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RG SAM (CNE) low dose formulation vaccine in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61)
Group V: RabAvert groupActive Control1 Intervention
In Part 1 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RabAvert in one arm and one intramuscular injection of saline solution in the other arm, according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61). In Part 2 of the study, healthy adults, 18 to 40 years of age, will receive one intramuscular injection of RabAvert in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61).
Group VI: Saline Placebo groupPlacebo Group1 Intervention
In Part 1 of the study, healthy adults, 18 to 40 years of age, will receive two intramuscular injections of saline placebo, one in each arm, according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61). In Part 2 of the study, healthy adults, 18 to 40 years of age will receive one intramuscular injections of saline placebo in one arm according to a 0, 2, 6-month schedule (i.e. at Days 1 and 61).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A)
2019
Completed Phase 1
~160
Lowest dose formulation of RG SAM (CNE) vaccine (GSK3903133A)
2019
Completed Phase 1
~160
Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A)
2019
Completed Phase 1
~160
Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A)
2019
Completed Phase 1
~160

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,805 Previous Clinical Trials
8,379,689 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
3,604 Previous Clinical Trials
6,144,729 Total Patients Enrolled
~26 spots leftby Nov 2025
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