Johnson & Johnson Launches Phase 3 Trial of RSV Vaccine in Adults

Johnson & Johnson recently initiated a Phase 3 clinical trial to study its RSV vaccine's efficacy, safety, and immunogenicity against lower respiratory tract disease (LRTD) in adults.

The randomized Phase 3 EVERGREEN study will enroll 23,000 adults aged 60 years and older throughout North America and across Europe, Asia, and the Southern Hemisphere.

Trial participants will receive either one dose of the vaccine or a placebo. After a year, participants who received the RSV vaccine will receive either the active vaccine again or a placebo. 

Researchers will follow participants for at least two RSV seasons. 

Researchers initiated the EVERGREEN study based on positive results from the Phase 2b CYPRESS study, which was the first large study evaluating the safety and efficacy of Johnson & Johnson's RSV vaccine against RSV-associated LRTD in vaccinated adults aged 65 and older in the US. 

"Positive data from our first RSV vaccine efficacy study and the initiation of the Phase 3 EVERGREEN study are crucial milestones in the clinical development of our investigational RSV adult vaccine, which has the potential to safely and effectively prevent lower respiratory tract disease caused by RSV in older adults," Penny Heaton, MD, global therapeutic area head of vaccines at Janssen, said in the announcement.

"Preventive solutions to address the significant morbidity and mortality in older adults caused by RSV have long been an unmet need," Heaton continued. 

In 2019, FDA granted breakthrough designation for Johnson & Johnson's RSV vaccine based on clinical data with the company's RSV senior vaccine that may demonstrate substantial improvement compared to standard-of-care. 

RSV leads to nearly 58,000 hospitalizations annually among children younger than five years old, 177,000 hospitalizations among adults 65 years of age and older, and 14,000 deaths among adults 65 years and older, according to the CDC. 

Although there are currently no vaccines to prevent RSV, big pharma companies, including Pfizer, have developed promising RSV vaccine candidates over the last year. 

In September, Pfizer initiated a Phase 3 clinical trial evaluating the efficacy, immunogenicity, and safety of a single dose of its respiratory syncytial virus (RSV) vaccine candidate in adults.

The placebo-controlled RENOIR study will enroll nearly 30,000 participants 60 years of age and older. The study's primary objective is the prevention of moderate to severe lower respiratory tract illness during the first RSV season.