Abstract / Summary
This review was conducted to evaluate the safety of intravenous lipopolysaccharide (IV LPS) for human immunology research through a scoping assessment of published clinical trials and pertinent case reports. As a collection of case studies reporting rare instances of sinus pauses following IV LPS had been reported in 2005, along with suggested approaches to minimize them, we limited our review to articles published since January 2006 in order to focus on contemporary safety. PRISMA Extension for Scoping Reviews (PRISMA-ScR) guidelines were followed. Articles meeting inclusion criteria were identified in PubMed through September 2026. From 252 articles, we identified 165 distinct studies, with the majority ( n = 117) limiting enrollment to males only. These studies included a total of 3,870 volunteers, almost exclusively healthy volunteers, with an approximate mean age of 28.3 years. In all studies, IV LPS elicited a dose-dependent inflammatory response characterized by elevations of heart rate, body temperature, and influenza-like symptoms that typically resolved by 8 h post dosing. Syncope was the only unanticipated adverse event identified, with 3 cases reported among nearly 4,000 LPS-treated volunteers over the last 21 years of contemporary practice. The rarity of adverse events across the 165 studies identified through PubMed suggests that IV LPS was generally reported to be safe and well tolerated, although precautions should be taken to minimize vagally induced sinus pauses. not applicable.