Respiratory syncytial virus (RSV) strain surveillance study (MK-1654-010)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001082
• Study ID:
  1000001082
• Official title and acronym:
  Respiratory syncytial virus (RSV) strain surveillance study (MK-1654-010)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Clesrovimab (also known as MK-1654 or ENFLONSIA) is a fully human IgG1 monoclonal antibody (mAb) that targets the respiratory syncytial virus (RSV) fusion (F) protein to prevent RSV entry into host cells. Clesrovimab received FDA approval in June 2025 for the prevention of RSV lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season.; RSV sequences can drift over time, resulting in a possibility of emergence of viral resistance to any monoclonal antibody (mAb). By regularly monitoring the genetic sequences of circulating RSV strains, researchers can track changes in the virus and identify new strains that may be resistant to treatment. The primary objective is to evaluate the presence of sequence variations affecting the RSV genome over a 5-year period, with a particular focus on the region of the F protein where clesrovimab binds (known as Site IV).
• Study status:
  Planned

Research institutions and networks

Institutions

Merck Sharp & Dohme LLC

United States

Study timelines

Date when funding contract was signed

Actual:01/05/2024

Study start date

Planned:01/09/2027

Data analysis start date

Planned:01/06/2033

Date of final study report

Planned:31/07/2034

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable