Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RabAvert · 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...
RabAvert is an investigational monoclonal antibody being studied for the prevention of virus diseases, specifically rabies. It is currently in clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety and immunogenicity in healthy adults.
RabAvert is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and immunogenicity for the prevention of rabies.
RabAvert is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.
RabAvert has one completed Phase 1 clinical trial with the identifier NCT04062669. This study evaluated the safety and immunogenicity of the experimental rabies vaccine in healthy adults in the United States. The trial enrolled 160 participants and was randomized, double-blind, and placebo-controlled.
RabAvert is a monoclonal antibody designed to target and neutralize the rabies virus. By binding to the virus, it may help the immune system prevent infection. The drug is being studied for its ability to generate an immune response against rabies in healthy adults.