The VAccine cLinical study reporting gUidEline: the VALUE checklist with explanation and elaboration

BACKGROUND: The number of clinical vaccine studies published each year is large and increasing as vaccinology and biotechnology advance. CONSORT and STROBE provide reporting guidelines for randomised clinical trials and observational studies, but neither addresses vaccine-specific items that should be included in vaccine study reports. Thus, there is a need to develop a guideline for reporting studies of a vaccine's characteristics such as immunogenicity, efficacy, effectiveness, reactogenicity, and safety. METHODS: Using the EQUATOR Network's "Guidance for Developers of Health Research Reporting Guidelines," we established a core working group to conduct a systematic literature review and develop an initial list of reporting elements for vaccine studies based on CONSORT and STROBE. A 42-member Delphi expert group, composed of clinical vaccine researchers, methodologists, medical journal editors, and other experts, provided comments and suggestions on the initial checklist through two rounds of Delphi surveys. Working group members refined and finalised the checklist after each round, with the approval of advisory group members. FINDINGS: Two rounds of Delphi surveys with 42 multidisciplinary global experts generated 87 qualitative comments, producing a final 22-item checklist across 15 domains, including 9 dedicated vaccine-specific reporting items. All items were refined with detailed explanations and representative clinical study examples. INTERPRETATION: VAccine cLinical trial reporting gUidEline (VALUE) aims to provide a minimum set of vaccine-specific reporting items for experimental and observational clinical studies that evaluate characteristics of vaccines. Developed with methods recommended by the EQUATOR collaborative network, VALUE complements CONSORT and STROBE statements by addressing vaccine-specific needs, aiming to serve as a valuable resource for vaccine researchers and improve reporting of clinical vaccine studies. FUNDING: This work was funded by the Non-profit Central Research Institute Fund of Chinese Academy of Medical Sciences, the National Key Research and Development Program of China, and the Vincent and Lily Woo Foundation.