Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pentamer/gB/Adjuvant vaccine · 1 trial · 1 indication
The assessed solicited administration site adverse events were erythema (injection site redness), pain and swelling.
The assessed solicited administration site adverse events were arthralgia, fatigue, headache, fever and myalgia. Fever was defined as body temperature ≥38.0°Celsius/100.4°Fahrenheit.
An unsolicited AE is defined as an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited AEs include both serious and non-serious AEs.
An SAE is defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, caused a congenital anomaly/birth defect, or was any other situation identified according to medical or scientific judgment. An unsolicited SAE is defined as an SAE that was not included in a list of solicited events using a Participant Diary.
An unsolicited AE is defined as an AE that was not included in a list of solicited events using a Participant Diary. The solicited AEs that had an onset after 7 days post each dose administration are considered unsolicited AEs. Unsolicited AEs include both serious and non-serious AEs.
MAE is defined as an AE for which the participant 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.
The hematological and biochemical parameters included alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, white blood cells (WBC). Categories reported when comparing normal range and Day 1 hematological and biochemical laboratory results are defined as follows: \<parameter\>, \<range at timing\> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 8 hematological and biochemical laboratory results are defined as follows: \<parameter\>, \<range at timing\> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 61 hematological and biochemical laboratory results are defined as follows: \<parameter\>, \<range at timing\> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 68 hematological and biochemical laboratory results are defined as follows: \<parameter\>, \<range at timing\> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 181 hematological and biochemical laboratory results are defined as follows: \<parameter\>, \<range at timing\> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 188 hematological and biochemical laboratory results are defined as follows: \<parameter\>, \<range at timing\> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
| Arm | Type | Description |
|---|---|---|
| Pentamer (low dose)/glycoprotein B (gB) (low dose)/Adjuvant group | EXPERIMENTAL | Participants received a dose of the candidate cytomegalovirus (CMV) vaccine consisting of a combination of low dose of pentamer and low dose of gB antigens, adjuvanted, at Day 1, Day 61 and Day 181 intramuscularly. |
| Pentamer (medium dose)/gB (low dose)/Adjuvant group | EXPERIMENTAL | Participants received a dose of the candidate CMV vaccine consisting of a combination of medium dose of pentamer and low dose of gB antigens, adjuvanted, at Day 1, Day 61 and Day 181 intramuscularly. |
| Pentamer (medium dose)/gB (medium dose)/Adjuvant group | EXPERIMENTAL | Participants received a dose of the candidate CMV vaccine consisting of a combination of medium dose of pentamer and medium dose of gB antigens, adjuvanted, at Day 1, Day 61 and Day 181 intramuscularly. |
| Pentamer (high dose)/gB (medium dose)/Adjuvant group | EXPERIMENTAL | Participants received a dose of the candidate CMV vaccine consisting of a combination of high dose of pentamer and medium dose of gB antigens, adjuvanted, at Day 1, Day 61 and Day 181 intramuscularly. |
| Placebo Group | PLACEBO_COMPARATOR | Participants received a dose of placebo at Day 1, Day 61 and Day 181 intramuscularly. |
| Name | Type | Description |
|---|---|---|
| Pentamer (low)/gB(low)/Adjuvant vaccine | BIOLOGICAL | Three doses of the candidate CMVsu vaccine consisting of a combination of low dose pentamer and low dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule. |
| Pentamer (med)/gB(low)/Adjuvant vaccine | BIOLOGICAL | Three doses of the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and low dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule. |
| Pentamer (med)/gB(med)/Adjuvant vaccine | BIOLOGICAL | Three doses of the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and medium dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule. |
| Pentamer (high)/gB(med)/Adjuvant vaccine | BIOLOGICAL | Three doses of the candidate CMVsu vaccine consisting of a combination of high dose pentamer and medium dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule. |
| Placebo (saline solution) | COMBINATION_PRODUCT | Three doses of placebo (saline) are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule. |
Inclusion Criteria: * Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the participant prior to performance of any study specific procedure. * A healthy adult (woman or man), 18 to 50 years of a...
The Pentamer/gB/Adjuvant vaccine is an investigational cytomegalovirus (CMV) vaccine developed by GSK plc. It is designed to prevent cytomegalovirus infections and has been studied in healthy adult volunteers. It combines a pentamer antigen, a glycoprotein B (gB) antigen, and an adjuvant, and is also referred to as the Pentamer (low)/gB(low)/Adjuvant vaccine.
The Pentamer/gB/Adjuvant vaccine is being developed for the prevention of cytomegalovirus infections. CMV is the indication studied in its clinical program. The vaccine is administered to healthy adults, and its development focuses on generating an immune response against cytomegalovirus.
GSK plc, which trades under the ticker GSK, is the developer of the Pentamer/gB/Adjuvant vaccine. GSK is the sponsor of the clinical program evaluating this cytomegalovirus vaccine candidate.
The Pentamer/gB/Adjuvant vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.
The Pentamer/gB/Adjuvant vaccine has been evaluated in one completed Phase 1 trial, NCT05089630, titled A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults. The trial enrolled 333 participants in the United States, was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 18 years and older.