GSK's Adjuvanted RSVPreF3 OA Vaccine Demonstrates 94.1% Reduction in Severe Disease and 82.6% Overall Efficacy in Pivotal Phase III Trial

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News on October 20, 2022 / BIOON / -- GSK recently announcedRespiratory Syncytial Virus (RSV) Older Adult (OA) Candidate VaccinePositive results from the pivotal Phase 3 clinical trial AReSVi-006. This is a randomized, placebo-controlled, observer-blind, multi-national Phase 3 trial designed to evaluateEfficacy of a Single-Dose Adjuvanted RSVPreF3 OA Candidate Vaccine in Adults Aged 60 Years and Older. The trial enrolled approximately 25,000 participants from 17 countries.

The results showed that the trial met the primary endpoint:In adults aged 60 years and older, the adjuvanted RSVPreF3 OA candidate vaccine was highly effective, with an overall vaccine efficacy of 82.6% against RSV lower respiratory tract disease (RSV-LRTD).(96.95% CI: 57.9-94.1; 7 cases in 12,466 people vs 40 cases in 12,494 people).

In addition,High vaccine efficacy was also observed consistently across a set of pre-specified secondary endpoints., highlighting the potential impact of the adjuvanted RSVPreF3 OA candidate vaccine on populations at greatest risk of severe RSV outcomes. Adjuvanted RSVPreF3 OA candidate vaccineVaccine efficacy against severe RSV-LRTD is 94.1%(95% CI: 62.4-99.9; 1 case in 12,466 vs 17 cases in 12,494). Severe RSV-LRTD was defined as LRTD with at least 2 lower respiratory tract symptoms, or as severe according to the investigator's assessment.

In subjects with comorbidities (such as underlying cardiopulmonary and endocrine metabolic diseases), the vaccine efficacy was 94.6%.(95%CI:65.9-99.9; 1 case in 4937 people vs 18 cases in 4861 people);In the elderly population aged 70-79, the observed vaccine efficacy was 93.8%.(95% CI: 60.2-99.9; 1 case in 4487 people vs 16 cases in 4487 people).

In addition, the adjuvant RSVPreF3 OA candidate vaccineVaccine efficacy against RSV-A and RSV-B subtype LRTD is consistent（Subtype A: 84.6%, 2 cases in 12,466 people vs 13 cases in 12,494 people;Subtype B: 80.9%(5 cases among 12,466 people vs 26 cases among 12,494 people),Consistent with the robust neutralizing antibody response generated against these two subtypes.

In the trial, the candidate vaccine was well-tolerated and had a good safety profile. The observed adverse events were generally mild to moderate and transient, with the most common being injection site pain, fatigue, myalgia, and headache.

AReSVi-006 Trial Results (Source: GSK)

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.Based on the data from the aforementioned Phase 3 clinical trials, GSK anticipates submitting the marketing application for the adjuvanted RSVPreF3 OA candidate vaccine in the second half of 2022.

GSK Chief Scientific Officer Tony Wood said, "Despite more than 60 years of research, RSV remains one of the major infectious diseases without a vaccine. In light of this, it is indeed an extraordinary outcome. We believe that, given the high efficacy demonstrated by this pivotal trial, our candidate vaccine has the potential to help reduce the significant global burden of RSV-related diseases in the elderly population, including those at risk of severe outcomes due to age or underlying comorbidities."

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-related decline in immunity and underlying conditions, elderly individuals are at high risk of severe RSV disease. RSV can exacerbate conditions such as chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure, and may lead to serious outcomes like pneumonia, hospitalization, and death. Each year, RSV causes over 360,000 adult hospitalizations and more than 24,000 deaths globally. Adults with underlying conditions are more likely to seek medical advice and have higher hospitalization rates compared to those without these conditions.

RSVPreF3 OA candidate vaccine contains the 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 that GSK has already marketed. The combination of antigen and adjuvant may help overcome the natural decline in immunity associated with aging, which can help protect the elderly from the challenges of RSV disease.

AReSVi-006 is part of GSK's comprehensive RSV evidence generation program. The trial will continue to evaluate the annual re-vaccination schedule and long-term protection across multiple seasons after a single dose of the adjuvanted RSVPreF3 OA candidate vaccine. The trial's safety is being closely monitored, and safety data will be continuously reviewed by internal and external Independent Data Monitoring Committees. (Bioon.com)

Source: GSK’s older adult respiratory syncytial virus (RSV) vaccine candidate shows 94.1% reduction in severe RSV disease and overall vaccine efficacy of 82.6% in pivotal trial