Johnson & Johnson Discontinues Phase 3 Study Evaluating Respiratory Syncytial Virus Vaccine

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that it will discontinue its phase 3 EVERGREEN (NCT04908683) study evaluating an investigational respiratory syncytial virus (RSV) vaccine, according to a statement by the company.¹

“By periodically refocusing our portfolio, Janssen ensures that we are deeply invested in products that have the power to transform patients’ lives,” Bill Hait, MD, PhD, executive vice president of Chief External Innovation and medical officer and interim head, Janssen R&D, said in the statement.¹ “We remain focused on advancing our differentiated pipeline, improving the lives of millions of patients and developing new modalities in areas with the greatest unmet medical need.”

The company announced the initiation of the EVERGREEN study, which was aimed to evaluate the efficacy, safety, and immunogenicity of the investigational vaccine, in 2021. Investigators were comparing the vaccine to a placebo in approximately 23,000 individuals aged 60 years and older throughout North America, Europe, Asia, and the Southern Hemisphere.²

The study’s initiation was based on positive results from the phase 2b CYPRESS (NCT03982199) trial, the first large study to evaluate the efficacy and safety of the RSV vaccine for adults aged 65 years and older in the United States.²

In September 2019, the FDA granted breakthrough therapy designation to the investigational RSV vaccine, which was based on substantial improvement compared to available standard of care on clinically significant endpoints.²

Janssen’s decision to discontinue the RSV adult vaccine program is part of an effort to make strategic decisions for its pipeline and research and development investments.¹

However, other companies, including GSK, Moderna, and Pfizer continue to investigate RSV vaccines.

Recently, the FDA’s Vaccine and Related Biological Products Advisory Committee voted that Pfizer’s RSC bivalent vaccine candidate, PF-06928316 (RSVpreF), is safe and effective.³

The FDA’s decision was based on data from the RENOIR (NCT05035212) study, evaluating the efficacy, immunogenicity, and safety of a single dose of PF-06928316 in approximately 37,000 individuals aged 60 years and older who received 120μg of the vaccine or the placebo.³

The findings showed efficacy of 66.7% against RSV-associated lower respiratory tract illness defined by 2 or more symptoms.³

Additionally, GSK’s RSV vaccine candidates met the primary endpoint of vaccine efficacy against RSV in adults aged 60 years and older.⁴

The company will also be conducting 3 additional phase 3 trials, NCT05590403, NCT05568797, and NCT05559476, which will expand to individuals aged 50 to 59 years with underlying comorbidities who may benefit from the RSV vaccination.⁴

The data will build upon additional data from the AReSVi-006 (NCT04886596) phase 3 efficacy trial and the AReSVi-004 (NCT04732871) immunogenicity trial.⁴

Moderna’s investigational RSV vaccine candidate, mRNA-1345, in adults aged 60 years or older, was granted breakthrough therapy designation by the FDA.⁵

The designation was based on positive topline data from the ConquerRSV phase 3 pivotal efficacy trial. The study met its primary endpoints, which included a vaccination efficacy of 83.7% against RSV lower respiratory tract disease by 2 or more symptoms and efficacy of 82.4% against RSV lower respiratory tract disease defined by 3 or more symptoms.⁵

In August 2021, the vaccine candidate was granted fast track designation by the FDA.⁵

References

1. Janssen provides portfolio update. News release. Johnson & Johnson. March 29, 2023. Accessed March 30, 2023. https://www.jnj.com/janssen-provides-portfolio-update

2. Janssen announces start of phase 3 trial for investigational respiratory syncytial virus (RSV) vaccine in older adults. Johnson & Johnson. September 29, 2021. Accessed March 30, 2023. https://www.jnj.com/janssen-announces-start-of-phase-3-trial-for-investigational-respiratory-syncytial-virus-rsv-vaccine-in-older-adults

3. Hunter, E. FDA Advisory Committee supports vaccine candidate for severe RSV in older adults. Pharmacy Times. March 1, 2023. Accessed March 30, 2023. https://www.pharmacytimes.com/view/fda-advisory-committee-supports-vaccine-candidate-for-severe-rsv-in-older-adults

4. Gallagher, A. GSK’s respiratory syncytial virus vaccine candidate meets primary efficacy endpoint. Pharmacy Times. February 27, 2023. Accessed March 30, 2023. https://www.pharmacytimes.com/view/gsk-s-respiratory-syncytial-virus-vaccine-candidate-meets-primary-efficacy-endpoint

5. Antrim, A. FDA grants breakthrough therapy designation to Moderna for investigational RSV vaccine.