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HKBU researchers co-develop a reporting checklist for vaccine clinical studies-VALUE
28 September 2026
The VALUE (VAccine cLinical study reporting gUidEline), a reporting guideline for vaccine clinical studies jointly developed by Hong Kong Baptist University (HKBU) and The Affiliated Traditional Chinese Medicine Hospital of Guangzhou Medical University, was published in eBioMedicine in September 2026. The HKBU research team was led by Ms Yanfang MA and Professor Zhaoxiang BIAN of the School of Chinese Medicine.
Driven by rapid advances in vaccinology and biotechnology, the global output of vaccine‑related clinical research continues to grow. The internationally adopted CONSORT and STROBE reporting guidelines are designed for randomised controlled trials and observational clinical studies, respectively; however, neither contains vaccine‑specific reporting items. Distinct from conventional drug trials, vaccine clinical studies require full disclosure of critical information including vaccine technology platforms, adjuvant components, humoral/cellular immunogenicity endpoints, formulae for vaccine efficacy calculation, and grading criteria for reactogenicity and adverse events. Omission of such key information can undermine objective assessment of vaccine immunogenicity, protective efficacy and safety, and impede research reproducibility, peer review and public‑health decision‑making. Against this background, a dedicated reporting guideline for vaccine clinical studies is urgently needed.
This project was registered on the EQUATOR Network platform on 25 January 2022. Its development strictly followed the methodological recommendations from the EQUATOR Network. A scoping review of 360 high‑quality vaccine clinical studies was performed to identify baseline reporting elements for vaccines. A multidisciplinary Delphi panel of 42 experts across five continents was assembled, consisting of vaccine clinical researchers, vaccine developers, medical journal editors, public‑health policy specialists and methodological experts. Following two rounds of Delphi surveys and multiple cycles of discussion and revision by the advisory group, the consensus‑based full VALUE checklist was finalised.
Key achievements and academic value of the VALUE Checklist: 1) The first standalone reporting guideline specifically for vaccine clinical studies worldwide. VALUE is not an extension of CONSORT or STROBE and can be used independently. Its vaccine‑specific reporting items are applicable to both experimental studies (e.g., randomised controlled trials) and observational studies. 2) Complete item set with practical real‑world examples. The guideline comprises 15 domains and 22 reporting items. Each item is supplemented with detailed explanation and elaboration, alongside illustrative examples extracted from published clinical studies, enabling direct implementation by researchers, journal editors and peer reviewers. 3) Address widely recognised reporting gaps in vaccine research. Core reporting components are explicitly defined: vaccine technology platforms, adjuvant composition, vaccination schedules, definitions of humoral‑ and cell‑mediated immunogenicity endpoints, standardised vaccine‑efficacy calculation formulae, and graded reporting for stratified adverse events and reactogenicity outcomes.
VALUE complements the global framework of clinical‑study reporting guidelines. It aims to enhance transparency, completeness, and reproducibility of vaccine clinical‑study reports, and provides a standardised tool for vaccine manuscript writing, journal peer review, literature interpretation, and public‑health decision‑making. Moving forward, the research team will carry out multi‑language translations, disseminate the guideline at academic conferences, and collect end‑user feedback to inform iterative updates of future versions.