GlaxoSmithKline (GSK) today announced positive preliminary data from its Phase III clinical study (NCT05590403), which assessed immune response and safety alexvi (Respiratory Syncytial Virus (RSV) Adjuvanted Vaccine) for adults 50 to 59 years of age, including those at increased risk for lower respiratory tract disease (LRTD:) lower respiratory tract disease, its English abbreviation) is caused by RSV in adults due to underlying comorbidities. The results were presented today at a meeting of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP). The vaccine is currently approved in the United States for active immunization to prevent LRTD caused by RSV in adults 60 years of age and older. It is also approved in Europe, Japan and other countries.
The vaccine induced immune responses in adults aged 50 to 59 years who are at increased risk for RSV disease due to selected underlying comorbidities that were non-inferior to those observed in adults aged 60 years and older immune response, meeting the common primary objective of the trial. The vaccine’s effectiveness has previously been demonstrated in adults 60 and older. The co-primary endpoint was also met in the broader group of adults ages 50 to 59 who participated in the trial. Safety and reactogenicity data are consistent with those observed during the initial Phase III development program results. The most common local adverse event was pain, and the most common systemic adverse events were fatigue and headache, most of which were transient and mild in intensity.
Elderly RSV
Tony Wood, Chief Scientific Officer GSK commented: “This study strengthens our confidence that our vaccine can help protect adults aged 50 to 59 years and those at increased risk of RSV LRTD. “We will submit these data for regulatory review as soon as possible, aiming to do so for the first time in history RSV vaccine options are available for adults in this age group. “
RSV is a common respiratory virus that can cause severe respiratory illness. Estimates of infection and hospitalization rates may be higher than those reported in many developed countries. Adults who are at increased risk due to advanced age, immunocompromise, or underlying comorbidities such as chronic obstructive pulmonary disease (COPD), asthma, or chronic heart failure face a considerable burden of RSV-related disease. RSV can exacerbate these conditions and lead to pneumonia, hospitalization, or death.
Final results from the trial will be presented at an upcoming medical conference and submitted for publication in a peer-reviewed journal. The data will also be sent to regulators to support possible expansion of the technical table.