GSK Announces Positive Topline Results from Phase III Trial of Single-Dose Adjuvanted RSVPreF3 OA Vaccine in Older Adults

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News on June 20, 2022 /BioValleyBIOON/ -- GSK recently announced positive topline results from a pre-specified interim efficacy analysis of the Phase III clinical trial, AReSVi 006, for its respiratory syncytial virus (RSV) vaccine candidate for older adults (OA). AReSVi 006 is a randomized, placebo-controlled, multinational Phase III trial designed to evaluate the efficacy of a single dose of the adjuvanted RSVPreF3 OA vaccine candidate in adults aged 60 years and older. The trial enrolled approximately 25,000 participants across 17 countries.

It is worth mentioning that,The adjuvant RSVPreF3 OA candidate vaccine is the first to demonstrate efficacy in adults aged 60 years and older.StatisticsRSV vaccine with statistical and clinical significance.Independent Data Monitoring Committee (IDMC)The interim analysis was reviewed and determined to have exceeded the primary endpoint.. In addition,RSVPreF3 OA Demonstrates Consistent Effectiveness Against RSV Types A and B, Key Secondary Endpoints, in Adults Aged 70 Years and OlderDuring the trial period, no unexpected safety issues were observed.

The results of the AReSVi 006 trial will be published in peer-reviewed journals and at upcoming scientific conferences. The AReSVi 006 trial will continue to evaluate the annual revaccination schedule and long-term protection across multiple seasons following a single dose of the adjuvanted RSVPreF3 OA candidate vaccine.

GSK Chief Scientific Officer and R&D President Dr. Hal Barron stated: "These data indicate that our candidate RSV vaccine provides exceptional protection for older adults against RSV.InfectionThe severe consequences. RSV remains one of the few major infectious diseases without a vaccine. These data have the potential to make a meaningful impact on the treatment of RSV and could reduce the global annual number of 360,000 hospitalizations and over 24,000 deaths. Based on these data, we plan to immediately engage with regulatory authorities and expect to submit regulatory applications in the second half of 2022."

RSV is a common contagious virus that affects the lungs and respiratory tract. It is one of the major remaining infectious diseases without a vaccine or specific treatment. Due to age-relatedImmunityDue to decreased strength and underlying diseases, the elderly are at high risk of severe RSV illness. RSV can exacerbate conditions such as chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure, leading to serious consequences like pneumonia, hospitalization, and death. Each year, RSV causes over 360,000 adult hospitalizations and more than 24,000 deaths globally. Adults with underlying diseases are more likely to seek medical advice and have higher hospitalization rates compared to those without these conditions.

RSVPreF3 OA Candidate Vaccine Contains Recombinant Subunit Prefusion RSV F Glycoprotein Antigen (RSVPreF3) and is Combined with GSK's Proprietary AS01 Adjuvant.AS01 has been used in several adjuvant vaccines marketed by GSK. The combination of antigen and adjuvant may help overcome the natural decline in immunity associated with aging, which could aid in protecting the elderly from the challenges of RSV disease.

AReSVi 006 is part of GSK's comprehensive RSV evidence generation program. Internal results from a recent parallel Phase III trial, AReSVi 004, indicate that,In adults aged 60 years and above, a single dose of the RSVPreF3 OA candidate vaccine induced strong humoral and cellular immune responses, remaining above pre-vaccination levels for at least six months post-vaccination.The safety of the AReSVi 006 trial is being closely monitored, and safety data will be continuously reviewed by internal and external independent data monitoring committees. (Bioon.com)

Source of the original text:GSK announces positive pivotal phase III data for its respiratory syncytial virus (RSV) vaccine candidate for older adults