Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as VAC52416
ExPEC10V · 1 trial · 1 indication
Number of participants with solicited local AEs for 14 days after vaccination on Day 1 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local (injection site) AEs included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). All solicited AEs at the injection site (local) were considered related to the study vaccine administration.
Number of participants with solicited systemic AEs 14 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Solicited systemic AEs included fatigue, headache, nausea, fever and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 14 days post-vaccination (day of vaccination and the subsequent 14 days).
Number of participants with unsolicited AEs up to 29 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Number of participants with SAEs up to Day 181 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Number of participants with solicited local AEs for 14 days after vaccination on Day 1 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local (injection site) AEs included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). All solicited AEs at the injection site (local) were considered related to the study vaccine administration.
Number of participants with solicited systemic AEs 14 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Solicited systemic AEs included fatigue, headache, nausea, fever and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 14 days post-vaccination (day of vaccination and the subsequent 14 days).
Number of participants with unsolicited AEs up to 29 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Number of participants with SAEs up to Day 181 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
GMTs of serotype-specific total IgG serum antibodies as measured by multiplex ECL based immunoassay were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and exotoxin protein A (EPA) were determined in serum from collected blood samples. Lower limit of quantification (LLOQ) values for O1A: 69149, O2: 65287, O4: 67356, O6A: 150748, O8: 72196, O15: 66910, O16: 71586, O18A: 70519, O25B: 61990, O75: 133019, and EPA: 66165. Any titer less than LLOQ is replaced by half of LLOQ (0.5\*LLOQ).
GMR of fold changes from baseline for serotype specific antibodies as measured by multiplex ECL based immunoassay on Day 15 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by multiplex ECL based immunoassay. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 15 and pre-vaccination (on Day 1). Any titer less than LLOQ is replaced by value of LLOQ.
Percentage of participants with a \>=2-fold and \>=4-fold increase (FI) from baseline in serotype specific serum antibody titers as measured by multiplex ECL based immunoassay on Day 15 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 15 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibody on Day 15 and pre-vaccination (on day 1) that is Day 15/Day 1. Any titer less than LLOQ is replaced by value of LLOQ.
GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples. LLOQ values were: O1A: 53, O2: 51, O4: 29, O6A: 47, O8: 196, O15: 37, O16: 54, O18A: 12, O25B: 65, and O75: 37. Any titer less than LLOQ is replaced by half of LLOQ (0.5\*LLOQ).
GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Day 15 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 15 and pre-vaccination (on Day 1). Any titer less than LLOQ is replaced by value of LLOQ.
Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibody titers as measured by MOPA on Day 15 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 15 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, and O75 was calculated as the ratio of titer values of serum antibody on Day 15 and pre-vaccination (on day 1) that is, Day 15/Day 1. Any titer less than LLOQ is replaced by value of LLOQ.
GMTs of serotype-specific total IgG serum antibodies as measured by multiplex ECL based immunoassay were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples. LLOQ values for O1A: 69149, O2: 65287, O4: 67356, O6A: 150748, O8: 72196, O15: 66910, O16: 71586, O18A: 70519, O25B: 61990, O75: 133019, and EPA: 66165. Any titer less than LLOQ is replaced by half of LLOQ (0.5\*LLOQ).
GMR of fold changes from baseline for serotype-specific antibodies as measured by multiplex ECL based immunoassay on Day 30 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by multiplex ECL based immunoassay. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 30 and pre-vaccination (on Day 1). Any titer less than LLOQ is replaced by value of LLOQ.
Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibody titers as measured by multiplex ECL based immunoassay on Day 30 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 30 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibody on Day 30 and pre-vaccination (on day 1) that is, Day 30/Day 1. Any titer less than LLOQ is replaced by value of LLOQ.
GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 were determined in serum from collected blood samples. For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. LLOQ values were O1A: 33, O2: 42, O4: 12, O6A: 62, O15: 75, O16: 17, O18A: 44, O25B: 58, O75: 14. Any titer less than LLOQ is replaced by half of LLOQ (0.5\*LLOQ).
GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Day 30 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 30 and pre-vaccination (on Day 1). For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. Any titer less than LLOQ is replaced by value of LLOQ.
Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibodies titers as measured by MOPA on Day 30 was reported. The fold (\>=2-fold and \>=4-fold increase from baseline to Day 30 for the serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 was calculated as the ratio of titer values of serum antibodies on Day 30 and pre-vaccination (on day 1 that is, Day 30/Day 1. For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype. Any titer less than LLOQ is replaced by value of LLOQ.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: ExPEC10V (Low Dose) | EXPERIMENTAL | Participants will be randomized to receive a single intramuscular (IM) injection of low dose ExPEC10V on Day 1. |
| Cohort 1: ExPEC10V (Medium dose) | EXPERIMENTAL | Participants will be randomized to receive a single IM injection of medium dose ExPEC10V on Day 1. |
| Cohort 1: ExPEC10V (High dose) | EXPERIMENTAL | Participants will be randomized to receive a single IM injection of high dose ExPEC10V on Day 1. |
| Cohort 1: ExPEC4V | EXPERIMENTAL | Participants will be randomized to receive a single IM injection of ExPEC4V on Day 1. |
| Cohort 1: Prevnar 13 | EXPERIMENTAL | Participants will be randomized to receive a single IM injection of Prevnar 13 on Day 1. |
| Cohort 2: ExPEC10V | EXPERIMENTAL | Participants will be randomized to receive a single IM injection of selected dose of ExPEC10V on Day 1. The ExPEC10V dose used in Cohort 2 will be based on the primary analysis (Day 30) results of Cohort 1. |
| Cohort 2: Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive a single IM injection of matching placebo on Day 1. |
| Name | Type | Description |
|---|---|---|
| ExPEC10V | BIOLOGICAL | Participants will receive a single IM injection of ExPEC10V (1 of 3 doses \[low or medium or high\]) in Cohort 1 and ExPEC10V selected dose (based on the primary analysis results of Cohort 1) in Cohort 2 on Day 1. |
| ExPEC4V | BIOLOGICAL | Participants will receive a single IM injection of ExPEC4V on Day 1. |
| Prevnar 13 | BIOLOGICAL | Participants will receive a single IM injection of Prevnar 13 on Day 1. |
| Placebo | BIOLOGICAL | Participants will receive single IM injection of matching placebo on Day 1. |
Inclusion Criteria: * Must have a body mass index (BMI) of greater than (\>) 18.5 or less than 40 kilogram per meter square (kg/m\^2) * Before randomization, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; or not i...
ExPEC10V is being developed for the prevention of extraintestinal pathogenic Escherichia coli, or ExPEC, infections. It is an investigational monoclonal antibody product from Johnson & Johnson. It is not approved for any use and remains in clinical development.
ExPEC10V is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It is investigational and has not been approved by the FDA or any other regulatory agency.
ExPEC10V is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 study of the monoclonal antibody in older adults.
ExPEC10V has been studied in one completed Phase 1 trial, NCT03819049, titled A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health. The trial enrolled 836 participants across the United States, Belgium, France, the Netherlands, and Spain.
The Phase 1 trial NCT03819049 was a randomized, double-blind, placebo-controlled study of three different doses of ExPEC10V in adults aged 60 to 85 years in stable health. It enrolled 836 participants, including healthy volunteers, and has been completed.
Yes, ExPEC10V is also known as VAC52416. The Phase 1 trial NCT03819049 refers to the candidate by both names, so searches for VAC52416 and ExPEC10V refer to the same Johnson & Johnson monoclonal antibody candidate.