Modify CT Protocol: CDSCO Panel Tells GSK on Respiratory Syncytial Virus(RSV) Vaccine

New Delhi: Reviewing the Phase III clinical trial protocol presented by the drug major GSK for the Respiratory Syncytial Virus (RSV) vaccine (Recombinant Adjuvanted), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit revised clinical trial protocol with an increased sample size for both cohorts of more than 60 years and 50-59 years.

In addition, the committee asked the firm to submit a detailed clinical study report for the age group 50-59 years from all the clinical trials conducted globally and current regulatory status.

Furthermore, the expert panel advised to include more clinical trial sites from the southern part of India in the revised clinical trial protocol.

This came after the drug maker GlaxoSmithKline Pharmaceuticals presented the Phase III clinical trial protocol titled “A Phase III randomized, placebo-controlled, observer-blind study in India to evaluate 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 of Respiratory Syncytial Virus (RSV) vaccine (Recombinant Adjuvanted)."

RSV is spread from person to person through close contact with someone who is infected via secretions from coughing and sneezing or touching objects such as toys or doorknobs that have the virus on them. It takes between two and eight days from the time of exposure for someone to become ill.

RSV is a highly contagious virus that causes infections of the lungs and breathing passages in individuals of all age groups. RSV circulation is seasonal, typically starting during the fall and peaking in the winter. In older adults, RSV is a common cause of lower respiratory tract disease (LRTD), which affects the lungs and can cause life-threatening pneumonia and bronchiolitis (swelling of the small airway passages in the lungs).

At the recent SEC meeting for Vaccine held on 27th February 2024, the expert panel reviewed the Phase III clinical trial protocol for the Respiratory Syncytial Virus (RSV) vaccine(Recombinant Adjuvanted).

After detailed deliberation, the committee noted that the proposed study design is descriptive and not based on statistical analysis with the number of subjects too low for the prospective population of cohort 1 older adults ≥ 60 years of age & cohort II adults 50‑59 years of age with various co-morbidities.

Furthermore, the committee found that the vaccine is not yet approved in any other country in the proposed age group of 50-59 years.

In view of the above, the committee recommended :

1) To submit a revised clinical trial protocol with an increased sample size for both cohorts of more than 60 years and 50-59 years.

2) To submit a detailed clinical study report for the age group 50-59 years from all the clinical trials conducted globally and current regulatory status.

3) To include more clinical trial sites from the southern part of India in the revision of the clinical trial protocol

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