In short
VXB-213 is an investigational vaccine candidate being studied for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) and human metapneumovirus (HMPV) in adults aged 60 years and older. One Phase 2b clinical trial is currently authorised and plans to enrol 8,000 participants. The trial will measure how well the vaccine prevents a first episode of RSV-LRTD or HMPV-LRTD within 12 months.
Key points
- VXB-213 is an investigational protein vaccine candidate against RSV and HMPV.
- The single authorised trial is a Phase 2b study in adults 60 years of age and older.
- The trial plans to enrol 8,000 participants.
- It measures the first episode of RSV-LRTD or HMPV-LRTD within 12 months.
- The vaccine is given as an intramuscular injection.
What is VXB-213?
VXB-213 is an investigational protein vaccine candidate. It is being developed to protect against two respiratory viruses: respiratory syncytial virus (RSV) and human metapneumovirus (HMPV). The substance is not yet an authorised medicine; it is currently being studied in clinical trials. The record describes it as an RSV+HMPV protein vaccine candidate.
How does VXB-213 work?
VXB-213 is a protein vaccine. Protein vaccines contain pieces of a virus, such as proteins, rather than the whole virus. When the vaccine is injected, the immune system recognises these proteins as foreign and builds a defence against them. In this case, the vaccine is designed to help the body defend against RSV and HMPV. The aim is to prevent lower respiratory tract disease (LRTD), which affects the lungs and airways.
Which conditions is VXB-213 being studied for?
- Respiratory syncytial virus (RSV) lower respiratory tract disease — a lung infection caused by RSV that can lead to serious illness in older adults.
- Human metapneumovirus (HMPV) lower respiratory tract disease — a lung infection caused by HMPV, a virus related to RSV.
The trial focuses on preventing the first episode of RSV-LRTD or HMPV-LRTD within 12 months after vaccination.
How is VXB-213 given?
VXB-213 is given as an intramuscular injection. In the trial, the vaccine candidate is administered alongside a 0.9% sodium chloride (NaCl) diluent. The dose recorded in the registry is 00 ml millilitre(s), which indicates that the exact dose is not reported in the register.
What do the clinical trials show?
One clinical trial of VXB-213 is currently authorised. It is a Phase 2b study, which means it is testing both how well the vaccine works and how safe it is in a larger group of people. The trial plans to enrol 8,000 participants.
The main measures of the trial are the occurrence of the first episode of RSV-LRTD and the occurrence of the first episode of HMPV-LRTD within 12 months. These are called primary outcomes. The trial is interventional, meaning participants receive the vaccine candidate and are then followed over time.
Who can take part in these trials?
The trial enrols adults aged 60 years and older. The registry record does not list further inclusion or exclusion criteria. The study is authorised, meaning it has received approval to begin recruiting participants.
What side effects are known?
The registry record does not provide information on side effects of VXB-213. Side effects are typically collected and reported as part of the clinical trial results. No data from the supplementary sources is available to describe known side effects at this time.