Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
V710 · 3 trials · 2 indications
Geometric mean fold rise is calculated as the natural logarithm of the ratio of Day 14 and baseline antibody titers.
Vaccine-related adverse experiences are those determined by the investigator to be possibly, probably, or definitely vaccine-related.
Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.
Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.
Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay. The GMFR is the ratio of the antibody concentration at Day 14 to the antibody concentration at baseline.
Investigators were instructed to determine the seriousness and causality (relatedness to test vaccine) of each AE based on criteria defined in the protocol: A serious adverse event (SAE) is any AE that: * results in death, * is life threatening, * results in a persistent or significant disability/incapacity, * results in or prolongs an existing inpatient hospitalization, * is a congenital anomaly/birth defect, * is a cancer, * is an overdose, * or is another important medical event that may require medical or surgical intervention to prevent one of the outcomes listed above.
Participants with a serious vaccine-related adverse experiences (AE) (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).
| Arm | Type | Description |
|---|---|---|
| V710 | EXPERIMENTAL | V710 vaccination (60 mcg) single dose on Day 1 |
| Placebo | PLACEBO_COMPARATOR | Placebo single dose on Day 1 |
| V710 without MAA | EXPERIMENTAL | - |
| V710 with MAA | ACTIVE_COMPARATOR | - |
| V710 5 μg | EXPERIMENTAL | V710 S. aureus vaccine |
| V710 30 μg | EXPERIMENTAL | V710 S. aureus vaccine |
| V710 90 μg | EXPERIMENTAL | V710 S. aureus vaccine |
| Name | Type | Description |
|---|---|---|
| V710 | BIOLOGICAL | V710 vaccination (60 mcg, 0.5 ml) single injection on Day 1 |
| Placebo | BIOLOGICAL | Saline placebo (0.5 ml) single injection on Day 1 |
| V710 (30 µg) with MAA | BIOLOGICAL | Single 0.5-mL injection (30-µg) of V710 with MAA, intramuscularly |
| V710 (30 µg) without MAA | BIOLOGICAL | Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly |
| Comparator: Placebo | BIOLOGICAL | Single dose of saline placebo intramuscularly |
Inclusion Criteria: * Generally Good Physical Health Exclusion Criteria: * Received V710 Vaccine, Any Other Investigational S. Aureus Vaccine, Or Investigational S. Aureus Antibodies Before * Temperature Of Equal/Greater Than 100.4 Degrees F(38 Degrees C) Within The Past 48 Hours
V710 is being developed for the prevention of Staphylococcal infection. It is a monoclonal antibody studied as a vaccine candidate against Staphylococcus aureus. All clinical work to date has been in healthy adult volunteers rather than in patients with active infection.
V710 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the Phase 1 clinical program evaluating the candidate, including the first-in-man study and subsequent safety and immunogenicity trials in healthy volunteers.
V710 is in Phase 1 clinical development. Three Phase 1 trials have been completed, and no trials are currently active. The program enrolled 228 participants in total across randomized, double-blind, placebo-controlled studies conducted in healthy volunteers.
V710 has been studied in three completed Phase 1 trials: NCT00303069, the first-in-man study with 124 participants; NCT01324440, which evaluated a single dose with or without Merck aluminum adjuvant in 64 participants; and NCT00735839, conducted in 40 healthy male Japanese subjects.
Yes. V710 is also referred to as Merck 0657nI, and trial records describe formulations such as V710 (30 µg) with MAA and V710 with MAA, where MAA is Merck aluminum adjuvant. These names refer to the same Merck Staphylococcus aureus vaccine candidate.
V710 trials were randomized, double-blind, and placebo-controlled, enrolling healthy volunteers aged 18 and older, with one study restricted to males aged 20 and older. The studies assessed safety, tolerability, and immunogenicity of a single dose, with or without Merck aluminum adjuvant.