PP108 A Systematic Review Of Reactogenicity And Safety Of Recombinant Zoster Vaccine For Prevention Of Herpes Zoster In Adults
Bibliographic record
Abstract
Introduction Herpes zoster (HZ), also known as shingles, is characterized by a vesicular skin rash, often associated with acute pain and itching. The safety profile of the recombinant zoster vaccine (RZV) in adults aged 50 years and older and in adults aged 18 and older who are at increased risk of HZ was assessed in this systematic review. Methods A comprehensive electronic search was performed in Embase, MEDLINE, the Cochrane Library, and clinical trials registries. Searches were limited to the period from 2008 to July 2023. Article screening and data extraction were carried out by two independent reviewers. Risk of bias was assessed using the Cochrane revised Risk of Bias 2 (RoB2) tool for randomized controlled trials (RCTs). The Risk of Bias in Non-Randomized Studies of Interventions (ROBINS-I) tool was used to assess the quality of non-randomized studies. An adapted version of the Newcastle–Ottawa Scale was used for the appraisal of quality of non-comparative studies. Results Eighteen RCTs, four observational cohort studies, seven single-arm trials, and 11 single-arm observational studies were identified. Compared with placebo, solicited local (RZV: 74.1 to 84.0%; placebo: 7.9 to 11.9%) and systemic reactions (RZV: 53.0 to 66.1%; placebo: 6 to 11.4%) were more common in the vaccinated cohorts. Reactions were generally transient and mild to moderate in intensity. The most frequent reactions reported were pain at the reaction site, fatigue, and myalgia. The incidence of potential immune-mediated diseases (pIMDS), serious adverse events (SAEs), and fatalities was similar in vaccine and placebo groups. No SAEs, pIMDs, or deaths were reported as vaccine related. Conclusions The available data on RZV shows that while local and systemic adverse events are common with RZV, these are typically transient, and SAEs are uncommon in both the general population and those at increased risk of HZ.
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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 | 0.010 | 0.041 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.012 | 0.011 |
| Bibliometrics | 0.012 | 0.010 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.009 | 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".