A Respiratory Syncytial Virus (RSV) Prefusion F Protein Candidate Vaccine (RSVPreF3-OA) is Efficacious in Adults ≥ 60 Years of Age (YOA)
Bibliographic record
Abstract
Background RSV-associated acute respiratory infections (ARI), particularly lower respiratory tract diseases (LRTD), present a significant disease burden in older adults. Results from an ongoing study show the vaccine efficacy (VE) of the AS01E-adjuvanted RSVPreF3-OA in adults ≥60 YOA. Methods This phase 3, observer-blind, placebo-controlled, (NCT04886596) enrolled adults ≥60 YOA in several countries. Participants were randomized (1:1) to receive a single dose of RSVPreF3-OA or placebo before the RSV season. The primary objective was to demonstrate VE of a single dose of RSVPreF3-OA in preventing RSV-confirmed (qRT-PCR) LRTD during one RSV season. VE is reported also against severe RSV-confirmed LRTD, RSV-confirmed ARI, RSV-confirmed LRTD and RSV-confirmed ARI. Results A total of 26,664 participants were enrolled, of whom 24,960 (RSVPreF3-OA: 12,466; placebo: 12,494) were included in the efficacy analysis. The mean age was 69.5 (±6.5) years. Over a median follow-up of 6.7 months, 47 RSV-confirmed LRTD episodes were reported (RSVPreF3-OA: 7; placebo: 40), resulting in a VE of 82.6% (96.95% CI: 57.9–94.1), thus the primary objective was met. Consistently high VE across the clinical spectrum of RSV disease, from RSV-confirmed ARI (71.7% [95% CI: 56.2–82.3]) to severe RSV-confirmed LRTD (94.1% [95% CI: 62.4–99.9]) was observed. High VE was seen in different age groups and regardless of RSV subtype, baseline comorbidity or pre-frail status. Conclusion A single RSVPreF3-OA dose is highly efficacious against RSV-confirmed LRTD and RSV-confirmed ARI in adults ≥60 YOA, regardless of RSV disease severity, RSV subtype, baseline comorbidity and pre-frail status. Publication History Article published online: 02 May 2023 © 2023. Thieme. All rights reserved. Georg Thieme Verlag Rüdigerstraße 14, 70469 Stuttgart, Germany
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".