Comparing standard versus intensified pneumococcal vaccination regimens in patients with inflammatory bowel disease on biologics: a prospective, multicenter, randomized, open-label study
Bibliographic record
Abstract
BACKGROUND AND AIMS: Pneumococcal vaccination is essential for patients with inflammatory bowel diseases (IBD), but its efficacy is reduced in those on antitumor necrosis factor (TNF) or immunosuppressive therapy. This study compared immune responses to standard versus intensified pneumococcal vaccination strategies in IBD patients receiving anti-TNF (±immunosuppressors) or vedolizumab. METHODS: In a prospective, multicenter, randomized open-label study across 7 French university hospitals, IBD patients in clinical remission on biologic therapy (anti-TNF ± immunosuppressors, or vedolizumab) were randomized 1:1 to an intensified (PCV13/PCV13/PPSV23) or standard (PCV13/PPSV23) regimen. Vaccine response (ELISA and opsonophagocytic assays [OPA]), side effects, and disease activity were monitored over 36 months. The primary endpoint was vaccine response at month 5 (M5), defined as antibody titers >1 µg/mL for at least 9 of 13 serotypes in ELISA. RESULTS: One hundred and four patients (median age, 43 years; 60.6% male; 68.3% Crohn's disease) were randomized to the standard (n = 51) or intensified (n = 53) regimen. At M5, the vaccine response was significantly higher in the intensified group compared to the standard group, as measured by ELISA (53.2% vs. 27.1%; relative risk [RR[ = 1.96; 95% CI, 1.15-3.36; P = .009) and OPA (90.9% vs. 62.5%; P = .007). OPA responses remained higher in the intensified group at M12, M18, and M36. Reduced responses were associated with anti-TNF therapy, combination therapy, and Crohn's disease. Both regimens were well tolerated, with no differences in safety profiles or IBD relapse rates. CONCLUSIONS: Intensified vaccination significantly enhances and sustains immune response over 36 months, particularly benefiting patients with CD on anti-TNF therapy.
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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 | 0.006 | 0.004 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
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".