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Also known as Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A)
Low dose formulation of RG SAM vaccine · 1 trial · 1 indication
The following local AEs are solicited: pain, redness and swelling at injection site.
The following local AEs are solicited: pain, redness and swelling at injection site.
The following general AEs are solicited: fatigue, fever, nausea, vomiting, diarrhea, abdominal pain and headache. Fever is defined as temperature ≥ 38.0°C / 100.4°F. The preferred location for measuring temperature in this study is the oral cavity.
The following general AEs are solicited: fatigue, fever, nausea, vomiting, diarrhea, abdominal pain and headache. Fever is defined as temperature ≥ 38.0°C / 100.4°F. The preferred location for measuring temperature in this study is the oral cavity.
Unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study and as any solicited AE with onset outside the specified period of follow-up for solicited symptoms.
Unsolicited AE is defined as an AE reported in addition to those solicited during the clinical study and as any solicited AE with onset outside the specified period of follow-up for solicited symptoms.
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
Clinically significant abnormal laboratory findings (e.g. clinical chemistry and hematology) are reported. The investigator exercises his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.
A medically attended adverse event is an AE for which the participants received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (i.e., nurse practitioner or physician assistant or medical doctor) for any reason.
SAEs assessed include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient.
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
| Arm | Type | Description |
|---|---|---|
| Low dose (Ld-) RG SAM (CNE) group | EXPERIMENTAL | 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) |
| Medium dose (Md-) RG SAM (CNE) group | EXPERIMENTAL | 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. |
| Lower dose (Lrd-) RG SAM (CNE) group | EXPERIMENTAL | 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) |
| Lowest dose (Ltd-) RG SAM (CNE) group | EXPERIMENTAL | 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) |
| Saline Placebo group | PLACEBO_COMPARATOR | 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). |
| RabAvert group | ACTIVE_COMPARATOR | 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). |
| Name | Type | Description |
|---|---|---|
| Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A) | BIOLOGICAL | Subjects in the low dose (Ld-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) low dose formulation, administered intramuscularlyat Days 1 and 61. |
| Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A) | BIOLOGICAL | Subjects in the medium dose (Md-) RG SAM (CNE) group will receive 1 doses of RG SAM (CNE) medium dose formulation, administered intramuscularly at Day 1. |
| Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A) | BIOLOGICAL | Subjects in the Lower dose (Lrd-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) lower dose formulation, administered intramuscularly, according to a 0, 2-month schedule (i.e. at Days 1 and 61) |
| Lowest dose formulation of RG SAM (CNE) vaccine (GSK3903133A) | BIOLOGICAL | Subjects in the Lowest dose (Ltd-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) lowest dose formulation, administered intramuscularly, according to a 0, 2-month schedule (i.e. at Days 1 and 61) |
| Saline Placebo | DRUG | Subjects in the Saline Placebo group will receive 2 doses of saline Placebo, administered intramuscularly Day 1 and 61. |
| RabAvert | BIOLOGICAL | Subjects in the RabAvert Group will receive 2 doses of RabAvert vaccine, administered intramuscularly, at Days 1 and 61. |
Inclusion Criteria: * 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). * Written informed consent obtained from the partic...
The low dose formulation of RG SAM vaccine is an experimental rabies vaccine developed by GSK plc. It is a vaccine candidate studied in healthy adults for the prevention of rabies, a viral disease. It was evaluated in a Phase 1 clinical trial and is not an approved product.
It is being studied for protection against rabies, a viral disease. The Phase 1 trial enrolled healthy adult volunteers aged 18 years and older in the United States. The study assessed safety and immune response rather than confirmed protection against the disease.
GSK plc, which trades under the ticker GSK, is the developer of the low dose formulation of RG SAM vaccine. The company sponsored the Phase 1 study of this experimental rabies vaccine candidate in healthy adults.
The low dose formulation of RG SAM vaccine is in Phase 1 development. Its single clinical trial, NCT04062669, has been completed. The vaccine remains investigational and has not been approved by the FDA for any use.
The low dose formulation of RG SAM vaccine was studied in trial NCT04062669, titled a study to evaluate the safety and immunogenicity of GSK Biologicals' experimental rabies vaccine in healthy adults. The Phase 1 trial enrolled 160 participants in the United States and is completed.
Yes. The low dose formulation of RG SAM vaccine is also known as the low dose formulation of RG SAM (CNE) vaccine, or GSK3903133A. These names refer to the same GSK plc experimental rabies vaccine candidate studied in the Phase 1 trial NCT04062669.