In short
VXB-221 is an investigational protein-based vaccine being studied for the prevention of respiratory infections caused by respiratory syncytial virus (RSV) and human metapneumovirus (HMPV) in adults aged 60 years and older. One Phase 2b trial has been authorised in the EU Clinical Trials Information System (CTIS), planning to enrol 8,000 participants.
Key points
- VXB-221 is an investigational protein vaccine targeting both RSV and HMPV.
- The trial is in Phase 2b and is currently authorised in the EU.
- It plans to enrol 8,000 participants aged 60 years and older.
- The vaccine is given as an intramuscular injection.
- The main goal is to prevent lower respiratory tract disease caused by RSV or HMPV within 12 months.
What is VXB-221?
VXB-221 is an investigational protein vaccine candidate. It is being developed as a combined vaccine against two respiratory viruses: respiratory syncytial virus (RSV) and human metapneumovirus (HMPV). The vaccine is also referred to in the trial record as "RSV+HMPV protein vaccine (618)". VXB-221 has not yet received a marketing authorisation and remains an investigational substance studied in clinical trials.
How does VXB-221 work?
VXB-221 is a protein-based vaccine. Protein vaccines contain pieces of a virus, such as proteins from its surface, rather than the whole virus. When injected, these viral proteins are recognised by the immune system, which then produces antibodies and immune cells against them. If the vaccinated person later encounters the real virus, the immune system is already prepared to respond. The trial record describes VXB-221 as a protein vaccine candidate intended to prevent lower respiratory tract disease caused by RSV and HMPV.
Which conditions is VXB-221 studied for?
The authorised trial investigates VXB-221 for the prevention of two respiratory infections in older adults:
- Respiratory syncytial virus (RSV) infection — a common respiratory virus that can cause serious lower respiratory tract disease, particularly in older adults.
- Human metapneumovirus (HMPV) infection — a respiratory virus related to RSV that can also lead to lower respiratory tract disease in older people.
The trial is registered under the therapeutic area "Infections and infestations".
How is VXB-221 given?
VXB-221 is given as an intramuscular injection. The trial record lists the intervention as "RSV+HMPV protein vaccine (618)" for intramuscular injection. A separate arm in the trial uses a 0.9% sodium chloride (NaCl) diluent as a comparison.
What do the clinical trials show?
One Phase 2b clinical trial of VXB-221 has been authorised in the EU Clinical Trials Information System (CTIS). The trial is interventional and plans to enrol 8,000 participants aged 60 years and older. Its primary goal is to evaluate the clinical efficacy of the vaccine candidate for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and HMPV-associated lower respiratory tract disease (HMPV-LRTD) within 12 months after vaccination. The trial is currently in the status "Authorised", meaning it has received regulatory approval to proceed but has not yet reported results.
The main outcomes measured in the trial are the occurrence of the first episode of RSV-LRTD and the occurrence of the first episode of HMPV-LRTD. Lower respiratory tract disease refers to infections affecting the airways and lungs, which can be more serious in older adults.
What side effects are known?
The registry record for this trial does not provide information on side effects of VXB-221. As the trial is still in the authorised stage and no results have been published in the provided data, no side effect profile is available from these sources.