#2638 Recombinant zoster vaccine (RZV) confers persistent immune responses with no safety concerns 4 to 8 years after vaccination of adults with renal transplant
Notice bibliographique
Résumé
Abstract Background and Aims In immunocompromised populations, vaccination remains an important tool for the prevention of herpes zoster (HZ). RZV is immunogenic and is approved for vaccination of adults 18 years and older who are at increased risk of HZ including those who are immunocompromised due to their underlying diseases or therapy. To understand the durability of protection, long-term data is necessary. We evaluated the persistence of immunogenicity of 2 doses of RZV 4–8 years after vaccination, as well as long-term safety in renal transplant recipients. Method This open-label, long-term extension study (NCT04176939) enrolled renal transplant recipients on chronic immunosuppressants who received 2 doses of RZV in the primary study (NCT02058589)1. Immunogenicity persistence was evaluated for 2 years: at enrolment day (D) 1 which started 4–6 years after RZV vaccination in the primary study, month (M) 12, and M24. Results were also analysed by year post-dose 2. Immunogenicity was assessed by humoral immune (HI) response (anti-glycoprotein E [anti-gE] antibody geometric mean concentration [GMC]) and cell-mediated immune (CMI) response (frequencies of gE-specific CD4+ T-cells expressing ≥2 markers among IFN-γ, IL-2, TNF-α, CD40L). Long-term safety after RZV vaccination was also assessed up to M24. Suspected HZ was defined as a new HZ rash clinically diagnosed as per standard of care with no alternative diagnosis. Confirmed HZ cases were evaluated per study algorithm. Results A total of 68 participants who received the 2-dose RZV vaccination series were enrolled. The mean geometric increase in anti-gE antibody concentration was 2.93, 2.75, and 2.44 over pre-vaccination levels at D1, M12, and M24, respectively. Yearly assessments collectively with data from the primary study showed HI responses (anti-gE antibody GMC) peak at 1M post-dose 2, which declined by 12M post-dose 2, then remained at a lower, stable plateau from 4 to at least 8 years post-dose 2 and remained above pre-vaccination levels at all time points. At D1, M12, and M24, CMI median frequency remained above pre-vaccination levels, showing the same pattern as HI responses (Table 1). Three (4.4%) participants had suspected HZ episodes from the last visit in the primary study to D1. From D1 to M24, 3 (4.4%) participants had confirmed HZ episodes. There were 2 (2.9%) cases of rejection: 1 acute antibody-mediated rejection and 1 acute T-cell mediated rejection. Both incidents began more than 2000 days post-dose 2 and were deemed unrelated to RZV vaccination. Both participants recovered with treatment, and graft function was preserved. Fatal outcomes due to unrelated serious adverse events (SAEs) were reported for 6 participants. No related SAEs were reported since the last visit in the primary study up to M24. Conclusion RZV induced a persistent long-term immune response in renal transplant recipients on chronic immunosuppression. At 4–8 years after RZV vaccination, HI and CMI responses remained at stable levels above pre-vaccination. No safety signals were identified during the long-term follow-up after RZV vaccination. Funding: GSK Acknowledgements: Medical writing (Maria Maior) and coordination support were provided by Akkodis Belgium c/o GSK.
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».