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Studies to assess investigational drug to prevent RSV in infants

Posted by Canadian Center for Vaccinology on December 5, 2022 in General Announcements

The Canadian Center for Vaccinology is seeking participants for studies to examine the safety and effectiveness of an investigational drug to protect infants from RSV (Respiratory syncytial virus).

RSV is a common virus that can infect the lungs and air passages, such as the mouth, nose, and throat. Most children who get RSV have a mild cold. However, some children who get RSV may become sicker, such as children born before their expected due date or with certain heart and lung problems. 

There are no vaccines available to protect babies and children against RSV and the two approved drugs (palivizumab and ribavirin) are only used for babies  at high risk of getting seriously sick. The study drug, MK-1654, is called a monoclonal antibody, which works by imitating the body’s natural immune response until it can do so safely on its own.

What is involved?

Children participating in Study #1 will receive either the RSV drug - MK-1654, or placebo.

For Study #2, participants would  already be eligible for the RSV prevention program.  They will receive the RSV drug – MK1654 or Palivizumab.

Participants will then return for a number of follow up visits.

Who can participate?

We are conducting 2 infant studies:

  1. Under 1 year of age and healthy (more information: https://centerforvaccinology.ca/study/effectiveness-and-safety-of-a-merck-rsv-preventation-drug-in-healthy-pre-term-and-full-term-infants/)
  2. Under 1 year of age and born earlier than 30 weeks gestation or with bronchopulmonary dysplasia or heart conditions present since birth (more information: https://centerforvaccinology.ca/study/effectiveness-and-safety-of-a-merck-rsv-prevention-drug-in-infants-and-children-at-increased-risk-for-rsv-disease/)

If interested, please contact Aimee Gonzalez de Armas at ccfv@iwk.nshealth.ca or aimee.gonzalezdarmas@iwk.nshealth.ca