HARMONIE
Trial question
What is the role of nirsevimab for prevention of hospitalizations due to RSV infection in infants?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
48.0% female
52.0% male
N = 8058
8058 patients (3863 female, 4195 male).
Inclusion criteria: healthy infants ≤ 12 months of age, had been born at a gestational age ≥ 29 weeks, who were entering their first RSV season.
Key exclusion criteria: congenital or acquired immunodeficiency; active confirmed RSV infection at the time of randomization; active lower respiratory tract infection at the time of randomization; known systemic hypersensitivity to any study intervention components.
Interventions
N=4037 nirsevimab (a single intramuscular injection at a dose of 50-100 mg).
N=4021 standard care (no intervention).
Primary outcome
Hospitalization for respiratory syncytial virus-associated lower respiratory tract infection
0.3%
1.5%
1.5 %
1.1 %
0.8 %
0.4 %
0.0 %
Nirsevimab
Standard
care
Significant
decrease ▼
NNT = 83
Significant decrease in hospitalization for RSV-associated lower respiratory tract infection (0.3% vs. 1.5%; ARD -1.2, 95% CI -1.91 to -0.49).
Secondary outcomes
Significant decrease in very severe RSV-associated lower respiratory tract infection (0.1% vs. 0.5%; ARD -0.4, 95% CI -0.67 to -0.13).
Borderline significant decrease in hospitalization for lower respiratory tract infection from any cause (1.1% vs. 2.4%; ARD -1.3, 95% CI -2.6 to 0).
Safety outcomes
No significant difference in grade 3 adverse events.
Conclusion
In healthy infants ≤ 12 months of age, had been born at a gestational age ≥ 29 weeks, who were entering their first RSV season, nirsevimab was superior to standard care with respect to hospitalization for RSV-associated lower respiratory tract infection.
Reference
Simon B Drysdale, Katrina Cathie, Florence Flamein et al. Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants. N Engl J Med. 2023 Dec 28;389(26):2425-2435.
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