GSK pharma Gets CDSCO Panel Nod To study Respiratory Syncytial Virus vaccine RSVPreF3 OA

New Delhi: Advising to include clinical trial sites from various states in the southern part of India, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has given its nod to vaccine major GSK Pharma India to conduct the Phase III clinical trial of the Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted).

This came after the vaccine major GSK Pharma India presented the revised Phase-III clinical trial protocol titled,

“A Phase III, randomized, placebo-controlled, observer blind study in India to evaluate the immune response, reactogenicity, and safety of a single intramuscular dose of RSVPreF3 OA investigational vaccine when administered to older adults ≥ 60 years of age and adults 50‑59 years of age at increased risk of respiratory syncytial virus lower respiratory tract disease.”

Respiratory syncytial virus (RSV) belongs to the genus Orthopneumovirus within the family Pneumoviridae and order Mononegavirales. Members of this genus include human RSV, bovine RSV, and murine pneumonia virus. There are two major antigenic subtypes of human RSV (A and B), determined largely by antigenic drift and duplications in RSV-G sequences but accompanied by genome-wide sequence divergence, including within RSV-F.

Human RSV is a globally prevalent cause of lower respiratory tract infections in all age groups. In infants and young children, the first infection may cause severe bronchiolitis that can sometimes be fatal.

RSV is a common contagious virus affecting the lungs and breathing passages. Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age. RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure, and can lead to severe outcomes such as pneumonia, hospitalization, and death. Each year, RSV is estimated to cause approximately 177,000 hospitalizations in adults 65 years and older and 42,000 in adults aged 50–64 years old in the US.

Respiratory Syncytial Virus Vaccine, Adjuvanted, contains recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant.

The Medical Dialogues Team reported earlier that the US Food and Drug Administration (FDA) approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk.

At the recent SEC meeting for vaccine held on May 31, 2024, the expert panel reviewed the revised Phase-III Clinical Trial Protocol titled “A Phase III, randomized, placebo-controlled, observer blind study in India to evaluate the immune response, reactogenicity, and safety of a single intramuscular dose of RSVPreF3 OA investigational vaccine when administered to older adults ≥ 60 years of age and adults 50‑59 years of age at increased risk of respiratory syncytial virus lower respiratory tract disease.”

After detailed deliberation, the committee recommended the grant of permission to conduct a Phase III clinical trial as per the presented protocol.

In addition, the expert panel suggested that the firm should include clinical trial sites from various states in the southern part of India.

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