GSK’s RSV Vaccine Provides Protection Over 3 RSV Seasons in Adults at Increased Risk

Author(s):

Kennedy Ferruggia, Assistant Editor

Key Takeaways

Arexvy demonstrated significant efficacy in adults 60+ against RSV-LRTD, with 62.9% effectiveness and 67.4% against severe cases.
The vaccine is approved for adults 60+ and expanded to 50-59 with underlying conditions, marking it as the first RSV vaccine in the US.
The phase 3 trial involved 25,000 participants across 17 countries, confirming Arexvy's efficacy over three RSV seasons.
Adverse events were consistent with previous data, including injection site pain, fatigue, myalgia, headache, and arthralgia.

GSK announced new positive data for Arexvy (respiratory syncytial virus [RSV]; GSK) in providing protection through 3 full RSV seasons, including individuals at increased risk of infection. The results were found in the AReSVi-006 (Adult Respiratory Syncytial Virus)(NCT04886596) phase 3 clinical trial that assessed the efficacy of a single dose of Arexvy in adults 60 years and older, to protect against lower respiratory track disease (LRTD) over 3 seasons.¹

Triple Virus Lung Infection and Tripledemic Human lung infection and respiratory inflammation disease as influenza flu outbreak or pneumonia and pulmonary illness - Image credit: freshidea | stock.adobe.com

Image credit: freshidea | stock.adobe.com

The adjuvanted RSV vaccine contains a recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3) and is combined with a proprietary ASO1E adjuvant.^1-3 Additionally, Arexvy can provide protection against RSV as an estimated 64 million individuals of all ages are impacted worldwide each year. Individuals at increased risk for RSV include those that are immunocompromised and older in age. However, study authors noted that RSV can intensify conditions like chronic obstructive pulmonary disease, asthma, and chronic heart failure, which result in severe outcomes including hospitalization and death.¹

Arexvy was first approved by the FDA in May 2023, for the prevention of LRTD caused by RSV in individuals 60 years of age and older, becoming the first accepted RSV vaccine for use in the US and was also approved for this indication in 50 other countries.^1,2 Since the initial approval, the vaccine was granted an expanded indication in the US to treat adults 50 through 59 years of age at an increased risk of RSV due to underlying medical conditions.³

The current randomized, placebo-controlled, double-blind, multi-country phase 3 AReSVi-006 trial assessed the efficacy of the vaccine in 25,000 individuals 60 years and older from 17 countries. The study authors noted that the primary end point of the study was vaccine efficacy against RSV-LRTD after 1 RSV reason. Following the first RSV season, 12,469 individuals in the vaccine arm were randomly assigned to receive either the RSV vaccine or the placebo and were monitored for occurrence of RSV-LRTD.¹

About The Trial

Trial Name: Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

ClinicalTrials.gov ID: NCT04886596

Sponsor: GlaxoSmithKline

Completion Date: May 2024

The results found that a single dose of Arexvy displayed significant efficacy in adults 60 years and older, adults that are at an increased risk of RSV due to underlying medical conditions, and adults aged 70 to 79 years. Additionally, the investigators noted that the single dose demonstrated cumulative efficacy across 3 full RSV seasons. Compared to the placebo, Arexvy showed 62.9% clinical significance against RSV-LRTD and 67.4% against severe RSV-LRTD. In the third RSV season its efficacy was 48.0% against RSV-LRTD, according to study authors.¹

“We are excited by these new data which show that a single dose of Arexvy could help protect millions of older adults at risk of RSV disease over three seasons to benefit public health,” Tony Wood, PhD, chief scientific officer at GSK, said in a news release.¹

The most reported adverse events included injection site pain, fatigue, myalgia, headache, and arthralgia within 4 days of vaccination. However, the study authors noted that the safety and reactogenicity data was consistent with former results found in the phase 3 program.¹

The findings suggest that protection against 3 full RSV seasons has the potential to administer a single dose RSV vaccine per year that can offer optimal protection.¹

“This is the only RSV vaccine with efficacy and safety data available through three full seasons. We will continue to provide data on longer term follow-up to help recommending bodies determine future revaccination schedules,” said Wood in the release.¹

REFERENCES

1. GSK presents positive data for Arexvy, its respiratory syncytial virus (RSV) vaccine, indicating protection over three RSV seasons. GSK. News release. October 8, 2024. Accessed October 9, 2024. https://www.gsk.com/en-gb/media/press-releases/gsk-presents-positive-data-for-arexvy-its-rsv-vaccine-indicating-protection-over-three-rsv-seasons/.

2. Pharmacy Times Staff. FDA Approves First Respiratory Syncytial Virus Vaccine for Adults Aged 60 Years and Older. Pharmacy Times. News release. May 3, 2024. Accessed October 9, 2024. https://www.pharmacytimes.com/view/fda-approves-first-respiratory-syncytial-virus-vaccine-for-adults-aged-60-years-and-older.

3. McGovern G. FDA Approves Expanded Age Indication for Arexvy RSV Vaccine. Pharmacy Times. News release. June 10, 2024. Accessed October 9, 2024. https://www.pharmacytimes.com/view/fda-approves-expanded-age-indication-for-arexvy-rsv-vaccine.