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

Study type

• Study topic:
  Other
• Study topic, other:
  Virologic surveillance of the RSV virus
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Virologic surveillance
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Global RSV strain surveillance study; ;

Population studied

• Short description of the study population:
  Children under 5 years of age who seek medical attention due to a respiratory illness in one of the participating sites and test positive to RSV by Reverse Transcription Polymerase Chain Reaction (RT-PCR).;
• Age groups:
  • Neonate

    • Preterm newborn infants (0 – 27 days)
    • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
• Estimated number of subjects:
  2000

Study design details

• Study design:
  Global, multicenter, non-interventional RSV surveillance study collecting RSV-positive respiratory specimens from children <5 years over 5 years from a minimum of 4 North American sites and at least 2 sites from other global regions (e.g. Europe, South America, Asia Pacific region).
• Main study objective:
  The primary objective of this study is to evaluate genetic variation in circulating respiratory syncytial virus (RSV) strains over a 5-year period, with a particular focus on changes occurring within Site IV of the RSV fusion (F) protein, the region where clesrovimab binds. Other objectives of the study include estimating the seasonal prevalence of RSV F protein sequence variations and evaluating the phenotype of select RSV variants.; ;
• Setting:
  Children under 5 years of age who seek medical attention due to a respiratory illness in one of the participating sites and test positive to RSV by RT PCR.
• Outcomes:
  The study will provide a comprehensive assessment of genetic variation in circulating RSV strains collected from children under 5 years of age across multiple global regions. The primary endpoint is to evaluate the presence of sequence variations affecting the RSV genome over a 5-year period with a special focus on the clesrovimab binding epitope within Site IV of the F protein. Additional outcomes include assessing the total number of RSV-A and RSV-B subtypes and the association of these subtypes with patient characteristics; Evaluating the total number of RSV variants with polymorphisms in the clesrovimab binding epitope of the RSV F protein; Assessing sequence variations affecting the RSV F protein with special attention to Site IV of the RSV F protein predicted to decrease sensitivity to clesrovimab; Estimation of the seasonal and geographic prevalence of RSV F protein sequence variation; And evaluating the phenotype (viral fitness, sensitivity to mAb) of select RSV variants of interest.; ;
• Data analysis plan:
  RSV F protein gene sequences obtained from collected specimens will be compared with contemporary RSV-A and RSV-B reference strains to identify nucleotide changes and amino acid substitutions. Sequence alignments will be used to characterize genetic diversity in circulating RSV strains, with particular focus on Site IV of the RSV F protein, the clesrovimab binding epitope. A 10% variant allele frequency (VAF) threshold will be applied for variant reporting. Descriptive analyses will summarize the number and proportion of RSV samples containing amino acid substitutions in the F protein.