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

Must not be taking: Immunosuppressants, Antimalarials, Antituberculosis, others

Disqualifiers: Rabies history, Immunodeficiency, Autoimmune, others

Compensation: Varies

Number of Visits: 2

Duration: 2 months

160 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use investigational products, certain vaccines, immunosuppressants, or antimalarial drugs close to the vaccination period.

What data supports the effectiveness of the RG-SAM [CNE] vaccine treatment?

The research on adenoviral vaccines targeting neoantigens shows that they can effectively control tumor growth in mice, especially when combined with checkpoint inhibitors, suggesting potential effectiveness for the RG-SAM [CNE] vaccine. Additionally, studies on similar vaccines, like those targeting NGcGM3 gangliosides, have shown promising immune responses and clinical benefits in cancer patients. ^{1 2 3 4 5}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the experimental rabies vaccine intramuscularly on a 0, 2-month schedule

2 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person and virtual) for safety and immunogenicity assessments

Long-term follow-up

Evaluation of persistence of immunogenicity and monitoring for adverse events

18 months

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

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Immunologic Response Elicited in Breast Cancer Patients Receiving a NeuGcGM3-based Vaccine as Adjuvant Therapy. [2018]

2. England pubmed.ncbi.nlm.nih.gov

The mouse chorionic gonadotropin beta-subunit-like (muCG beta l) molecule produced by tumor cells elicits the switch of T-cell immunity response from TH2 to TH1 in mice immunized with DNA vaccine based on rhesus monkey homologous CG beta (rmCG beta). [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Experiments evaluating antitumor immunity induced by cholesterol hemisuccinate-treated syngeneic cell vaccines. [2019]

4. Egypt pubmed.ncbi.nlm.nih.gov

NGcGM3 ganglioside: a privileged target for cancer vaccines. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Adenoviral vaccine targeting multiple neoantigens as strategy to eradicate large tumors combined with checkpoint blockade. [2021]