AReSVi-006
Trial question
What is the role of RSV prefusion F protein vaccine in older adults?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
52.0% female
48.0% male
N = 24966
24966 patients (12915 female, 12051 male)
Inclusion criteria: adults ≥ 60 years of age
Key exclusion criteria: serious or unstable chronic disease; immunosuppression; history of reaction/hypersensitivity by any component of vaccine; recurrent/uncontrolled neurological disorders or seizures
Interventions
N=12467 RSVPreF3 OA vaccine (a single dose of an AS01E-adjuvanted RSV prefusion F protein-based candidate vaccine before RSV season)
N=12499 placebo vaccine (matching placebo vaccine before RSV season)
Primary outcome
Respiratory syncytial virus-related lower respiratory tract disease
1
5.8
5.8/1000 pt-y
4.3/1000 pt-y
2.9/1000 pt-y
1.4/1000 pt-y
0.0/1000 pt-y
RSVPreF3 OA vaccine
Placebo vaccine
Significant decrease ▼
Significant decrease in RSV-related lower respiratory tract disease (1 per 1,000 participant-years vs. 5.8 per 1,000 participant-years; AD -4.8 per 1,000 participant-years, 95% CI 62.4 to 99.9)
Secondary outcomes
No significant difference in RSV-related acute respiratory infection (3.9 per 1,000 participant-years vs. 13.9 per 1,000 participant-years; AD -10 per 1,000 participant-years, 95% CI -20.02 to 0.02)
No significant difference in RSV type A-related lower respiratory tract disease (0.3 per 1,000 participant-years vs. 1.9 per 1,000 participant-years; AD -1.6 per 1,000 participant-years, 95% CI -3.2 to 0)
Safety outcomes
No significant difference in serious adverse events and potential immune-mediated diseases.
Significant difference in any solicited reaction (72% vs. 28%).
Conclusion
In adults ≥ 60 years of age, RSVPreF3 OA vaccine was superior to placebo vaccine with respect to RSV-related lower respiratory tract disease.
Reference
Alberto Papi, Michael G Ison, Joanne M Langley et al. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. N Engl J Med. 2023 Feb 16;388(7):595-608.
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