Immune persistence and safety of the AS01 <sub>E</sub> -adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in adults 50–59 years of age, including at-increased-risk adults: A randomized controlled trial
Bibliographic record
Abstract
In this phase 3, randomized, placebo-controlled multi-country study, the AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine (adjuvanted RSVPreF3) was immunologically non-inferior at 1 month post-vaccination in adults 50–59 years of age (YOA) compared to adults ≥60 YOA, in whom efficacy was previously demonstrated. Here, we report end-of-study immunogenicity and safety results until 12 months post-vaccination. Participants 50–59 YOA were divided into an at-increased-risk (AIR) and a non-AIR subcohort, each randomized (2:1) to receive one dose of adjuvanted RSVPreF3 or placebo. A control cohort of participants ≥60 YOA received adjuvanted RSVPreF3. Humoral/cell-mediated immunity and safety were assessed. In total, 1152 participants 50–59 YOA received adjuvanted RSVPreF3 or placebo, and 381 participants ≥60 YOA received adjuvanted RSVPreF3. In all vaccinated groups, RSV-A and RSV-B neutralizing titers and RSVPreF3-specific polyfunctional CD4+ T-cell frequencies increased at 1 month post-vaccination and declined thereafter, but remained above baseline and placebo levels at 6 and 12 months post-vaccination. During the study, one vaccine-related serious adverse event (cold-type hemolytic anemia in a participant ≥60 YOA) was reported. Five participants died (all in the 50–59 YOA AIR subcohort, four had received adjuvanted RSVPreF3, one placebo); none of the deaths were considered vaccine-related. In conclusion, adjuvanted RSVPreF3 induced a humoral and cell-mediated immune response persisting until at least 12 months post-vaccination in adults 50–59 YOA, including those at increased risk for RSV disease. The vaccine had an acceptable 12-month safety profile in adults 50–59 YOA, consistent with that in adults ≥60 YOA.Trial Registration: ClinicalTrials.gov: NCT05590403
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| 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".