A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Experimental Rabies Vaccine in Healthy Adults

Recruiting at 3 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: GlaxoSmithKline

Compensation: Varies

Number of Visits: 0

160 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Eligibility Criteria

Inclusion Criteria

Written informed consent obtained from the participant prior to performance of any study specific procedure.

Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. participation in genetics research, completion of the electronic diary cards, return for follow-up visits).

Healthy participants as established by medical history and clinical examination before entering into the study.

Treatment Details

Interventions

• RG-SAM [CNE] vaccine

Participant Groups

Group I: Medium dose (Md-) RG SAM (CNE) group Experimental Treatment 1 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) group Experimental Treatment 1 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) group Experimental Treatment 1 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) group Experimental Treatment 1 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 group Active Control 1 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 group Placebo Group 1 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).

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

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Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School