Pfizer Launches Phase 3 Clinical Trial of RSVpreF Vaccine to Prevent Seasonal Respiratory Infections in Older Adults

On September 2, 2021, Pfizer announced the initiation of the Phase 3 RENOIR clinical trial for the bivalent prefusion F subunit investigational candidate vaccine RSVpreF, to evaluate the efficacy, immunogenicity, and safety of a single-dose vaccination in preventing respiratory syncytial virus (RSV) infection in adults aged 60 years and older.

RSV is a respiratory pathogen that can cause serious and life-threatening moderate-to-severe lower respiratory tract disease (msLRTI) in high-risk populations, such as infants, immunocompromised patients, and older adults. RSV infection has imposed a substantial disease burden globally. In China, RSV is a leading pathogen responsible for acute respiratory tract infections across all age groups. It is a seasonal disease that typically begins in autumn and peaks in winter. The virus infects individuals of all ages; while symptoms in most young individuals may resemble a common cold, it can be life-threatening for infants, immunocompromised individuals, and the elderly. Currently, there are no effective treatment options available for patients with RSV infection.

The global, randomized, double-blind, placebo-controlled Phase 3 clinical trial RENOIR is expected to enroll approximately 30,000 participants aged 60 years and older, and aims to evaluate the safety and efficacy of RSVpreF in preventing moderate-to-severe lower respiratory tract disease during the first RSV season.

In July 2021, Pfizer completed a Phase 2a trial evaluating the safety, immunogenicity, and efficacy of RSVpreF in a viral challenge model in healthy adults aged 18 to 50 years. Additionally, in April 2020, the Phase 2b proof-of-concept trial of RSVpreF reported positive topline results, assessing the safety, tolerability, and immunogenicity of RSVpreF in pregnant participants vaccinated at 18 to 49 years of age and their infants. Detailed results will be presented at upcoming scientific conferences.

References:

[1] Pfizer Announces Start of Phase 3 Clinical Trial in Adults for Its Investigational Vaccine Against Respiratory Syncytial Virus (RSV). Retrieved September 2, 2021, from https://www.businesswire.com/news/home/20210902005069/en

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