#2638 Recombinant zoster vaccine (RZV) confers persistent immune responses with no safety concerns 4 to 8 years after vaccination of adults with renal transplant
Bibliographic record
Abstract
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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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 | 0.000 |
| 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".