ConquerRSV
Trial question
What is the role of a single dose of mRNA-based RSV vaccine in older adults?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
49.0% female
51.0% male
N = 35413
35413 patients (17369 female, 18044 male).
Inclusion criteria: adults aged ≥ 60 years.
Key exclusion criteria: immunocompromised state; history of a serious reaction to any prior vaccination or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization; received or plans to receive any non-study vaccine within 28 days before or after day 1 study injection.
Interventions
N=17734 mRNA-based RSV vaccine (injection of 50 mcg of mRNA-1345 into the deltoid muscle).
N=17679 placebo (injection of saline into the deltoid muscle).
Primary outcome
Incidence of RSV-associated lower respiratory tract disease with ≥ 2 signs and symptoms within 14 days to 12 months after injection
1.4
8.8
8.8/1000 py
6.6/1000 py
4.4/1000 py
2.2/1000 py
0.0/1000 py
MRNA-based RSV
vaccine
Placebo
Significant
decrease ▼
Significant decrease in the incidence of RSV-associated lower respiratory tract disease with ≥ 2 signs and symptoms within 14 days to 12 months after injection (1.4/1000 py vs. 8.8/1000 py; AD -7.4/1000 py, 95% CI -11.79 to -3.01).
Secondary outcomes
Significant decrease in the incidence of RSV-associated lower respiratory tract disease with ≥ 3 signs and symptoms (0.5/1000 py vs. 2.7/1000 py; AD -2.2/1000 py, 96% CI 34.8 to 95.3).
Significant decrease in the incidence of RSV-associated acute respiratory disease (4.1/1000 py vs. 13.1/1000 py; AD -9/1000 py, 95% CI 50.9 to 79.7).
No significant difference in RSV A-associated lower respiratory tract disease with ≥ 2 signs and symptoms (3 events vs. 36 events; AD -33 events, 95% CI -66.06 to 0.06).
Safety outcomes
No significant difference in serious adverse events.
Significant differences in solicited local adverse reactions (58.7% vs. 16.2%), systemic adverse reactions (47.7% vs. 32.9%).
Conclusion
In adults aged ≥ 60 years, mRNA-based RSV vaccine was superior to placebo with respect to the incidence of RSV-associated lower respiratory tract disease with ≥ 2 signs and symptoms within 14 days to 12 months after injection.
Reference
Eleanor Wilson, Jaya Goswami, Abdullah H Baqui et al. Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. N Engl J Med. 2023 Dec 14;389(24):2233-2244.
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