Raw research data for zostavax
Executive summary
Publicly available "raw" research data for Zostavax exists in the form of clinical trial registries, regulatory reviews, peer‑reviewed trial reports and post‑licensure observational studies, but individual patient‑level datasets and complete trial datasets are not openly published in full; regulators and academic papers provide aggregated efficacy, safety and immunogenicity results [1] [2] [3]. The strongest trial evidence comes from two large randomized Phase III trials (the Shingles Prevention Study and ZEST) plus multiple immunogenicity and post‑licensure safety/effectiveness reports, while limitations include sparse public access to underlying patient‑level data and variable effectiveness in real‑world cohorts [2] [1] [4].
1. The large randomized trials: what the public documents show
Zostavax’s pivotal efficacy evidence is summarized in two Phase III randomized, placebo‑controlled trials: the Shingles Prevention Study (SPS) enrolled ~38,546 subjects ≥60 years and demonstrated a reduction in herpes zoster and postherpetic neuralgia, and the ZEST trial randomized ~22,439 subjects aged 50–59 to Zostavax or placebo [2] [1]. FDA and company submissions and peer‑reviewed summaries report the trial designs, sample sizes and the broad efficacy outcomes, and these documents form the primary "raw" sources that are publicly citable [1] [3].
2. Immunogenicity and mechanistic readouts available in papers
Mechanistic and immunologic readouts—antibody and cell‑mediated immunity (CMI) assays, ELISPOT and gpELISA metrics—are reported in clinical and translational studies showing that Zostavax boosts VZV‑specific CMI and recruits VZV‑specific T cells into skin on antigen challenge in older adults [5] [6]. These studies provide numeric group‑level immunologic data and timepoints (for example pre/post vaccine CMI increases and skin challenge scores) but do not typically publish full individual participant level spreadsheets as "raw" datasets [6] [5].
3. Safety data: trials, labels and post‑licensure surveillance
Safety summaries are available in FDA product information, clinical reviews and Phase IV reporting that document solicited adverse events, serious adverse events and specific subgroup safety notes (for example in HIV‑infected persons safety has not been established) as well as post‑licensure cohort analyses assessing short‑term hospitalization or ED visits after vaccination [7] [3] [8]. These sources give counts, rates and risk windows but again represent aggregated analyses rather than downloadable patient‑level raw data [8] [7].
4. Real‑world effectiveness and variability over time
Observational effectiveness studies supply another layer of empirical data: for instance a population‑based Stockholm study found an overall vaccine effectiveness of ~34% with strongest protection in ages 61–75, illustrating that real‑world impact can differ from trial efficacy and vary by age and follow‑up duration [4]. Systematic reviews and meta‑analyses have synthesized these disparate reports into comparative effectiveness statements but rely on the same published aggregate outcomes [9] [10].
5. Where the true "raw" datasets live — and why they’re hard to access
Regulatory review documents, ClinicalTrials.gov entries and peer‑reviewed articles constitute the accessible "raw research" footprint for Zostavax (p1_s1; p