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 distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".