Recently, GSK announced the latest data from the AReSVi-006 Phase III clinical study. The study (NCT04886596) aims to evaluate the protective efficacy of a single dose of Arexvy (recombinant respiratory syncytial virus vaccine) in preventing lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) infection in adults aged 60 years and above (including high-risk populations) over three complete RSV epidemic seasons.[1]. These data will be announced today at the American College of Chest Physicians Annual Meeting (CHEST 2024).Arexvy is the world's first RSV vaccine, and its approval is based on significant efficacy in adults aged 60 years and above, including high-risk populations with certain underlying medical conditions. The results published today show that a single dose of GSK’s RSV vaccine provided clinically meaningful cumulative protection over three complete RSV seasons. Compared to placebo, the vaccine demonstrated 62.9% efficacy (97.5% CI: 46.7-74.8, 48/12,468 vs 215/12,498) against RSV-associated lower respiratory tract disease (RSV-LRTD), and 67.4% efficacy (95% CI: 42.4-82.7, 15/12,468 vs 75/12,498) in preventing severe RSV-LRTD. In the third season, the vaccine showed 48.0% efficacy (95% CI: 8.7-72.0, 16/4,988 vs 61/10,031) against RSV-LRTD.The study results also showed that the vaccine was effective in protecting both elderly people aged 70-79 and adults with certain underlying medical conditions against different RSV subtypes.Since RSV can exacerbate the condition and potentially lead to hospitalization, the cumulative protection efficacy demonstrated by a single dose of Arexvy over three RSV seasons suggests its potential to bring about significant and positive impacts on public health. This vaccine will facilitate healthcare professionals in implementing year-round vaccination programs with greater flexibility. Over time, it is expected that recipients will require revaccination to maintain optimal protection levels. GSK will continue to share the protection efficacy and immune response data of Arexvy (including revaccination data) with immunization advisory bodies to inform vaccination schedules and future revaccination plans.RSV is a common and contagious virus that can cause lung and respiratory infections. Globally, approximately 64 million people of all ages are affected by this virus each year.[2]。Patients with underlying diseases, weakened immune function, or the elderly are at higher risk of contracting RSV. RSV infection can exacerbate underlying conditions, including chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure, and may lead to serious consequences such as pneumonia, hospitalization, and death.[3]In high-income countries, it is estimated that more than 465,000 adults aged 60 years and above are hospitalized due to RSV infection, and 33,000 die.[4]。GSK Chief Scientific Officer Tony Wood said, "We are delighted to see this new data, which shows that a single dose of the Arexvy vaccine can protect millions of elderly people at risk of RSV disease over three RSV seasons, benefiting public health. This is the only RSV vaccine with efficacy and safety data spanning three full seasons. We will continue to provide long-term follow-up data to assist immunization advisory bodies in determining future re-vaccination strategies."
*Absolute values for the vaccinated group and the placebo group.**Vaccine effectiveness estimated using Poisson models adjusted for age, region, and epidemic season.***By incorporating the epidemic season as a covariate and making corresponding adjustments to the data to reflect variability in disease incidence between different epidemic seasons.The study showed that the safety and reactogenicity data of the Arexvy vaccine were consistent with the results from previous Phase III clinical trials. During the first epidemic season, the overall tolerability data for the Arexvy vaccine were favorable. The most common adverse reactions were pain at the injection site, fatigue, myalgia, headache, and arthralgia within four days after vaccination.In addition to being presented at the American College of Chest Physicians Annual Meeting, the data will also be submitted to peer-reviewed scientific journals and regulatory authorities.This is a randomized, placebo-controlled, double-blind, global Phase III study aimed at evaluating the protective efficacy of a single dose and annual doses of GSK's recombinant RSV vaccine compared to placebo over three years in adults aged 60 and above. The study recruited approximately 25,000 participants from 17 countries. The primary endpoint of the study was the vaccine’s efficacy in preventing RSV-LRTD during one RSV season. The results were published in the New England Journal of Medicine in February 2023.[5]。After the first RSV season, 12,469 participants in the vaccine group were re-randomized to receive either the RSV vaccine or a placebo and were followed up to observe the incidence of RSV-LRTD. Compared with the placebo, the protective efficacy of a single dose of the vaccine against RSV-LRTD after two and three RSV seasons, as well as the vaccine's protective efficacy after annual revaccination, were secondary endpoints for verification.The Respiratory Syncytial Virus (RSV) vaccine (adjuvanted) contains a recombinant RSV F glycoprotein (RSVPreF3) stabilized in the pre-fusion conformation. This antigen is combined with GSK's proprietary adjuvant AS01 E.In May 2023, GSK's RSV vaccine was approved for the first time by the U.S. Food and Drug Administration (FDA) to prevent RSV-LRTD in individuals aged 60 years and older. Since then, the vaccine has been approved in 50 countries, including Europe and Japan, for the prevention of lower respiratory tract disease (LRTD) caused by RSV infection in individuals aged 60 years and above. Additionally, the vaccine has been approved in the United States and Europe for high-risk individuals aged 50-59 with underlying medical conditions. Other countries, including Japan, are currently reviewing this extended indication. The proposed trade name still requires approval from other market regulatory authorities.The use of this vaccine should follow official recommendations. As with any vaccine, not all recipients will develop a protective immune response.GSK's proprietary AS01 adjuvant system contains the QS-21 STIMULON adjuvant, licensed from Antigenics Inc., a wholly owned subsidiary of Agenus Inc.- Scroll up and down to view references -
[1] Clinicaltrials.gov, “Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above”. Available at: https://clinicaltrials.gov/study/NCT04886596 - last accessed: September 2024
[2] National Institute of Allergy and Infectious Diseases, Respiratory Syncytial Virus (RSV). Available at: https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv – last accessed: September 2024
[3] Centers for Disease Control and Prevention (CDC), RSV in Older Adults, 2024. Available at: https://www.cdc.gov/rsv/older-adults/index.html - Last accessed: September 2024
[4] Savic M, et al., “Respiratory syncytial virus disease burden in adults aged 60 years and older in high-income countries: a systematic literature review and meta-analysis”, in Influenza Other Respir Viruses, 2023, 17(1):e13031, DOI: 10.1111/irv.13031
[5] Papi A. et al, “Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults”, in New England Journal of Medicine, 2023;388:595-608 DOI: 10.1056/NEJMoa2209604
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