Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as VXB-241 60 mcg (Low Dose)
VXB-241 · 1 trial · 1 indication
GMFI is defined as geometric mean of ratios of specific antibody titer/concentration at each post-vaccination time point over pre-vaccination baseline.
Ratio of VXB-241 dose versus GMFI of RSV-A, RSV-B, hMPV-A and hMPV-B will be calculated.
| Arm | Type | Description |
|---|---|---|
| Stage 1, Day 1, Sequential Cohort 1 | EXPERIMENTAL | Younger and older adult participants will receive VXB-241 60 mcg (low dose) or Placebo, intramuscularly (IM), once on Day 1. |
| Stage 1, Day 1, Sequential Cohort 2 | EXPERIMENTAL | Younger and older adult participants will receive VXB-241 120 mcg (medium dose) or Placebo, IM, once on Day 1. |
| Stage 1, Day 1, Sequential Cohort 3 | EXPERIMENTAL | Younger and older adult participants will receive VXB-241 240 mcg (medium-high dose) or Placebo, IM, once on Day 1. |
| Stage 1, Day 1, Sequential Cohort 4 | EXPERIMENTAL | Younger and older adult participants will receive VXB-241 480 mcg (high dose) or Placebo, IM, once on Day 1. |
| Stage 2, Day 1, Concurrent Group 1a | EXPERIMENTAL | Older adult participants will receive VXB-241 60 mcg (low dose), IM, once on Day 1. |
| Stage 2, Day 1, Concurrent Group 1b | EXPERIMENTAL | Older adult participants will receive VXB-241 120 mcg (medium dose), IM, once on Day 1. |
| Stage 2, Day 1, Concurrent Group 1c | EXPERIMENTAL | Older adult participants will receive VXB-241 240 mcg (medium-high dose), IM, once on Day 1. |
| Stage 2, Day 1, Concurrent Group 1d | EXPERIMENTAL | Older adult participants will receive VXB-241 480 mcg (high dose), IM, once on Day 1. |
| Stage 2, Day 1, Concurrent Group 2a | ACTIVE_COMPARATOR | Older adult participants will receive Arexvy 120 mcg, IM, once on Day 1. |
| Stage 2, Day 1, Concurrent Group 3a | PLACEBO_COMPARATOR | Older adult participants will receive Placebo, IM, once on Day 1. |
| Group 1e: VXB-241 Revaccination in VXB-241 Recipients | EXPERIMENTAL | Approximately 50% of the older adult participants who received VXB-241 240 mcg, will receive VXB-241 240 mcg, IM, (based on 1 month post 1st IMP injection results), once on Day 364 in the second year of the study. |
| Group 1f: Placebo Revaccination in VXB-241 Recipients | PLACEBO_COMPARATOR | Approximately 50% of the older adult participants who received VXB-241 (any dose level), will receive Placebo, IM, once on Day 364 in the second year of the study. |
| Group 2b: Placebo Arexvy Revaccination | PLACEBO_COMPARATOR | All older adult participants who received Arexvy 120 mcg will receive Placebo revaccination, IM, once on Day 364 in the second year of the study. |
| Group 3b: VXB-241 | EXPERIMENTAL | All older adult participants who received Placebo will receive VXB-241 240 mcg (based on 1 month post 1st IMP injection results), IM, once on Day 364 in the second year of the study. |
| Name | Type | Description |
|---|---|---|
| VXB-241 60 mcg (Low Dose) | BIOLOGICAL | VXB-241 low dose, single, IM injection. |
| VXB-241 120 mcg (Medium Dose) | BIOLOGICAL | VXB-241 medium dose, single, IM injection. |
| VXB-241 240 mcg (Medium-high Dose) | BIOLOGICAL | VXB-241 medium-high dose, single, IM injection. |
| VXB-241 480 mcg (High Dose) | BIOLOGICAL | VXB-241 high dose, single, IM injection. |
| VXB-241 240 mcg | BIOLOGICAL | VXB-241 240 mcg (RSV preF 120 mcg + hMPV preF 120 mcg) (based on 1 month post 1st IMP injection results) single, IM injection. |
| Placebo | OTHER | Placebo, single, IM injection. |
| Arexvy 120 mcg | BIOLOGICAL | Arexvy 120 mcg, single, IM injection. |
Inclusion Criteria: 1. Male or female, 18 to 40 years of age (yoa) (younger adult) or 60 to 83 yoa (older adult). 2. Evidence of signed and dated participant informed consent form (PICF) prior to any study procedure, indicating that the participant has been informed of all pertinent aspects of the ...
VXB-241 is an investigational monoclonal antibody being studied in healthy volunteers. It is currently in a Phase 1 clinical trial in older adults to evaluate its safety and immunogenicity. The drug is being developed by Sanofi.
VXB-241 is a monoclonal antibody designed to target respiratory syncytial virus (RSV) and human metapneumovirus (HMPV). It is being studied as a bivalent vaccine candidate to provide protection against both viruses.
VXB-241 is being developed by Sanofi, a global biopharmaceutical company. Sanofi's stock is traded under the ticker symbol SNY on the NASDAQ.
VXB-241 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants.
VXB-241 is being studied in a Phase 1 clinical trial with the identifier NCT06556147. This trial is titled 'A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults' and is being conducted in Australia with 144 participants.
Yes, VXB-241 60 mcg (Low Dose) refers to a specific dosage strength of VXB-241. The drug is being evaluated in a clinical trial that includes this low-dose formulation as part of the study design.