Pfizer Launches Phase III MONeT Study of RSVpreF Vaccine in High-Risk Adults

Recently, Pfizer registered a Phase III clinical trial (MONET) on the ClinicalTrials.gov website, aiming to evaluate the safety, tolerability, and immunogenicity of the RSVpreF vaccine (PF-06928316) in preventing severe Respiratory Syncytial Virus (RSV) in high-risk adult patients. The expected start date for the MONET study is May 9, 2023, with an end date of March 22, 2024.

The study is divided into two parts (A and B): Part A is a multicenter, randomized, double-blind, placebo-controlled Phase III study, planning to enroll 525 adults aged 18–60 who are at high risk of severe RSV due to certain chronic diseases (excluding immunocompromised conditions). Participants will be randomly assigned in a 2:1 ratio to receive one dose of the RSVpreF vaccine or a placebo. Part B is a single-arm, open-label, multicenter Phase III study, planning to include over 200 immunocompromised adult patients, with approximately 100 aged 18–60 and another 100 over 60 years old. Participants will receive two doses of the RSVpreF vaccine, administered one month apart.

Study A and B have two primary endpoints: safety and primary immunogenicity. Safety indicators include the proportion of patients with local reactions, systemic reactions, adverse events, newly diagnosed chronic diseases, and serious adverse events. The efficacy indicator is the RSV-specific serum neutralizing antibody titer (GMT).

Currently, this vaccine has been proven effective in the elderly and newborns. Among them, the Phase III RENOIR trial for the prevention of RSV infection in people aged 60 and above showed that the vaccine had a protection rate of 66.7% against two or more symptoms, 85.7% against at least three or more symptoms, and 62.1% against acute respiratory diseases. The FDA is expected to make a regulatory decision this month.

In addition, the Phase III MATISSE study on active immunization of pregnant women to prevent RSV-related lower respiratory tract disease in infants from birth to 6 months showed that the vaccine efficacy against severe RSV-induced lower respiratory tract illness was 81.8% in the first 90 days after birth and 69.4% during the 6-month follow-up period, with a PDUFA date in August 2023.

This shows that the clinical trials conducted by Pfizer for the bivalent RSV candidate vaccine PF-06928316 are very comprehensive, aiming to cover application scenarios for all age groups. Facing the challenge from GSK, which has taken the lead in launching the world’s first RSV vaccine for the elderly, Pfizer's differentiated strategic advantage might help it secure a sufficient market share.

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