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MK-1654 - Prophylactic treatment to prevent Respiratory Syncytial Virus infection in infants

Infectious Disease, Infant and Newborn Health

Respiratory Syncytial Virus, or RSV, is the most common cause of hospitalisations in infants, and is associated with lower respiratory tract infections and bronchiolitis. Infants with underlying medical conditions, such as being born prematurely, are especially at risk and the disease can be life threatening.

This phase 3 randomised study involves the introduction of a new treatment for RSV. The new treatment is to be compared alongside the current industry standard with the hopes that this new treatment will be more effective and more efficient whilst also being cheaper to produce, improving quality of life of both healthy and at-risk infants.

Category
Trial Status
Recruiting
Trial Phase
Phase 3 Drug Trial
Registry Listing
Trial contact details
Contact Person
Mothers and Babies Research Team
Email
What you need to know

Who can take part?

  • The target of the study are infants (up to 12 months of age). In particular:

  • Infants born before the RSV season (approximately late April), or during the RSV season, which would be recommended Palivizumab (the current industry standard) in accordance with national and state guidelines. These infants, during the first RSV Season, would be randomly assigned to either:
    • Control arm: the infant receives Palivizumab
    • Intervention arm: the infant receives the new intervention

What is involved for you?

There are two distinct sets of pathways during RSV Season 1 (April 2023 to September 2023, approximately) During RSV Season 1:

  • Participants in either study arm will receive the intervention on Day 1 and Day 28
  • On day 60, participants on both arms will be unblinded (told what study arm they are in), with:
    • Control participants receiving additional dosages on day 60, 90, and 120 alongside safety follow-ups for a year
    • Intervention arm participants will receive safety follow-ups for a year

Some participants in both arms will be legible to join the RSV Season 2 (April 2024 to September 2024, approximately) phase, which involves:

  • All participants receiving the new study intervention regardless of what arm they were in previously
  • Safety follow-ups through until day 180 post dosage

Participants in both arms will also receive full physical examinations, blood withdrawals, and buccal swabs (DNA) for future biomedical research (optional).

Trial dates

This trial will be open for enrolment in April 2023.

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