The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus‐associated disease in breakthrough infections in adults ≥60 years of age
Bibliographic record
Abstract
Abstract Background Respiratory syncytial virus (RSV) is a contagious pathogen causing acute respiratory infections (ARIs). Symptoms range from mild upper respiratory tract infections to potentially life‐threatening lower respiratory tract disease (LRTD). In adults ≥60 years old, vaccine efficacy of a candidate vaccine for older adults (RSVPreF3 OA) was 71.7% against RSV‐ARI and 82.6% against RSV‐LRTD (AReSVi‐006/NCT04886596). We present the patient‐reported outcomes (PROs) from the same trial at the end of the first RSV season in the northern hemisphere (April 2022). Methods In this phase 3 trial, adults aged ≥60 years were randomized (1:1) to receive one dose of RSVPreF3 OA vaccine or placebo. PROs were assessed using InFLUenza Patient‐Reported Outcome (FLU‐PRO), Short Form‐12 (SF‐12), and EuroQol‐5 Dimension (EQ‐5D) questionnaires. Peak FLU‐PRO Chest/Respiratory scores during the first 7 days from ARI episode onset were compared using a Wilcoxon test. Least squares mean (LSMean) of SF‐12 physical functioning (PF) and EQ‐5D health utility scores were estimated using mixed effects models. Results In the RSVPreF3 OA group ( N = 12,466), 27 first RSV‐ARI episodes were observed versus 95 in the Placebo group ( N = 12,494). Median peak FLU‐PRO Chest/Respiratory scores were lower in RSVPreF3 OA (1.07) versus Placebo group (1.86); p = 0.0258. LSMean group differences for the PF and EQ‐5D health utility score were 7.00 (95% confidence interval [CI]: −9.86, 23.85; p = 0.4125) and 0.0786 (95% CI: −0.0340, 0.1913; p = 0.1695). Conclusions The RSVPreF3 OA vaccine, in addition to preventing infection, attenuated the severity of RSV‐associated symptoms in breakthrough infections, with trends of reduced impact on PF and health utility.
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| 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 | 0.001 |
| 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".