Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NgG 12.5 µg investigational vaccine · 1 trial · 1 indication
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature \>=38ºC; preferred location for measuring the temperature is oral cavity. Any = occurrence of the event regardless of intensity grade.
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator. An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for them since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.
The safety laboratory data included haematological parameters \[hemoglobin, lymphocytes, platelets, neutrophils, and white blood cells (WBC)\] and biochemical parameters (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 1 (baseline) and Day 8 haematological and biochemical laboratory results are defined as follows: \<parameter\>, \<range at baseline\>, \<range at timing\> (e.g. ALT, Within, Within). 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.
Incidence of first confirmed gonorrhea cases by positive Nucleic Acid Amplification Test (NAAT) at the anorectal and/or urogenital location were evaluated. The incidence rate (y/PT) of confirmed gonorrhea cases, expressed in terms of 100 person-years, was calculated as the number of confirmed gonorrhea cases (y) in a group, over the sum of individual person-times at risk (PT) in the same group, and multiplied by 100.
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature \>=38ºC; preferred location for measuring the temperature is oral cavity. Any = occurrence of the event regardless of intensity grade.
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator. An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for them since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.
The safety laboratory data included haematological parameters (hemoglobin, lymphocytes, platelets, neutrophils, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 1 (baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: \<parameter\>, \<range at baseline\>, \<range at timing\> (e.g. ALT, Within, Within). 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.
The safety laboratory data included haematological parameters (hemoglobin, absolute lymphocyte count, platelets, absolute neutrophil count, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 1 (baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: \<parameter\>, \<range at baseline\>, \<range at timing\> (e.g. ALT, Within, Within). 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. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
The safety laboratory data included haematological parameters (hemoglobin, lymphocytes, platelets, neutrophils, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 61 (baseline) and Day 68 haematological and biochemical laboratory results are defined as follows: \<parameter\>, \<range at baseline\>, \<range at timing\> (e.g. ALT, Within, Within). 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. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
The safety laboratory data included haematological parameters (hemoglobin, absolute lymphocyte count, platelets, absolute neutrophil count, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 61 (baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: \<parameter\>, \<range at baseline\>, \<range at timing\> (e.g. ALT, Within, Within). 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. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
| Arm | Type | Description |
|---|---|---|
| Phase 1: Neisseria gonorrhoeae GMMA (NgG) 12.5 micrograms (µg) Group | EXPERIMENTAL | Participants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61. |
| Phase 1: NgG 25 µg Group | EXPERIMENTAL | Participants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61. |
| Phase 1: NgG 50 µg Group | EXPERIMENTAL | Participants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61. |
| Phase 1: Placebo Group | PLACEBO_COMPARATOR | Participants received 2 doses of placebo on Day 1 and Day 61. |
| Phase 2: NgG Highest tolerated dose (HTD; 50 µg) Group | EXPERIMENTAL | Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1. |
| Phase 2: NgG dose below HTD (bHTD; 25 µg) Group | EXPERIMENTAL | Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1. |
| Phase 2: Placebo Group | PLACEBO_COMPARATOR | Participants received 2 doses of placebo on Day 1 and Day 61. |
| Name | Type | Description |
|---|---|---|
| NgG 12.5 µg investigational vaccine | BIOLOGICAL | 2 doses of NgG 12.5 µg investigational vaccine administered intramuscularly. |
| NgG 25 µg investigational vaccine | BIOLOGICAL | 2 doses of NgG 25 µg investigational vaccine administered intramuscularly. |
| NgG 50 µg investigational vaccine | BIOLOGICAL | 2 doses of NgG 50 µg investigational vaccine administered intramuscularly. |
| Placebo | COMBINATION_PRODUCT | 2 doses of placebo administered intramuscularly. |
Inclusion Criteria: Inclusion criteria for the dose-escalation safety lead-in part * Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written or witnessed/thumb printed informed consent obtained from the participant prior to perfor...
NgG 12.5 µg is an investigational vaccine developed by GSK plc for the prevention of sexually transmitted diseases. It is a vaccine candidate, not an approved product, and it has been studied in a Phase 1 clinical trial in healthy adults aged 18 to 50 years.
NgG 12.5 µg is being developed for sexually transmitted diseases. The vaccine candidate targets Neisseria gonorrhoeae, the bacterium that causes gonorrhea, and was tested in healthy adult volunteers to assess safety and efficacy in preventing gonococcal infection.
GSK plc, which trades under the ticker GSK, is the developer of the NgG 12.5 µg investigational vaccine. GSK conducted the clinical development program for this gonorrhea vaccine candidate, including the Phase 1 trial NCT05630859.
NgG 12.5 µg is in Phase 1 development. Its only recorded trial, NCT05630859, is a completed Phase 1 study. The vaccine is investigational and has not been approved by the FDA or any other regulatory agency for commercial use.
NgG 12.5 µg has been studied in one clinical trial, NCT05630859, titled Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age. The Phase 1 trial enrolled 1,009 participants across the United States, Brazil, France, Germany, the Philippines, South Africa, Spain, and the United Kingdom, and it is now completed.
Yes. The Phase 1 trial NCT05630859 for NgG 12.5 µg was randomized, double blind, and placebo controlled. It enrolled 1,009 healthy volunteers aged 18 to 50 years across eight countries and has been completed.