August 16, 2022

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Respiratory Syndrome Virus vaccine: Pfizer RSVpreF enters Phase 3 trials

Respiratory Syndrome Virus (RSV) vaccine: Pfizer RSVpreF enters Phase 3 trials

Respiratory Syndrome Virus vaccine: Pfizer RSVpreF enters Phase 3 trials. 

Respiratory Syndrome Virus (RSV) vaccine! Pfizer RSVpreF enters Phase 3 clinical trials: prevent RSV-related lower respiratory tract diseases in the elderly ≥60 years old!

RSV is a common and common cause of acute respiratory diseases and may be life-threatening for the elderly.

Pfizer has announced RENOIR study three starts, in its assessment of the elderly population aged 60 and over in a single dose of respiratory syncytial virus (RSV) divalent pre-fusion F The effectiveness, immunogenicity and safety of subunit vaccine (RSVpreF) . RSV is a seasonal disease that usually starts in the fall and peaks in winter when colds and other respiratory diseases are more common.

RENOIR is a global, randomized, double-blind, placebo-controlled phase 3 study, which is expected to enroll approximately 30,000 elderly people 60 years and older. The main purpose of the study is to evaluate the safety and effectiveness of a single dose of RSVpreF in the prevention of moderate to severe lower respiratory disease (msLRTI ​​RSV) during the first RSV season . In this study, the first batch of subjects have been immunized with a single dose of RSVpreF.

Dr. Kathrin U. Jansen, Senior Vice President and Head of Vaccine Development at Pfizer, said: “Respiratory syncytial virus (RSV) is an important cause of severe respiratory diseases in the elderly, which can lead to disability and death. An effective vaccine will help. In order to protect the elderly from this highly infectious disease, this is an important unmet medical need. The launch of this phase 3 study is an important step towards our goal of full immunity to RSV disease. These include the development of a potential first vaccine to help prevent RSV disease in the adult population, and ongoing efforts to help protect infants through maternal immunity, but still require regulatory approval.”

Respiratory Syndrome Virus vaccine: Pfizer RSVpreF enters Phase 3 trials

Respiratory syncytial virus (RSV) is a common and common cause of acute respiratory diseases . The virus is highly contagious and affects the lungs and respiratory tract. RSV infection occurs in people of all ages and is like the common cold to most young people, but it can be life-threatening for infants, immunocompromised persons and the elderly.

The elderly, as well as those with chronic heart disease, lung disease, or weakened immune systems, are at increased risk of serious infections. In the United States, it is estimated that more than 177,000 elderly ≥65 years of age are hospitalized for RSV each year, and 14,000 die from RSV each year. Currently, there is no vaccine to prevent RSV, and the medical community is limited to providing supportive care to patients.

RSVpreF is an RSV vaccine candidate being developed by Pfizer. The vaccine is based on basic scientific discoveries, including the discovery of the National Institutes of Health (NIH), which describes in detail a type of RSV used to attack human cells. The crystal structure of the key form of the viral protein. NIH research shows that antibodies that protect humans from RSV infection target a form of this viral protein. Applying the insights from this important work, Pfizer has developed and tested many vaccine candidates, and in preclinical evaluations, it has identified candidate vaccines that can stimulate a strong antiviral immune response, thus obtaining this candidate vaccine that Pfizer is evaluating in human trials. RSVpreF.

In July 2021, Pfizer provided the latest results of a Phase 2a study, which was carried out in healthy adults 18-50 years old, and evaluated the safety, immunogenicity and effectiveness of RSVpreF in a virus challenge model . The results of this study allowed Pfizer to advance RSVpreF to phase 3 clinical trials. The detailed results of the Phase 2a study will be shared in future scientific forums.

In April 2020, the Phase 2b proof-of-concept study of RSVpreF achieved positive results. The study evaluated the safety, tolerability and immunogenicity of RSVpreF among pregnant women and their babies aged 18-49 who were vaccinated, aiming to enable babies to gain the ability to resist lower respiratory tract diseases (LRI) through maternal immunity. The detailed results of the study will be shared in future medical conferences . In November 2018, the US FDA granted RSVpreF Fast Track Status (FTD): Active immunization of pregnant women to prevent infant RSV-related lower respiratory tract diseases.

(source:internet, reference only)

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