{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T07:04:53Z","timestamp":1784271893147,"version":"3.55.0"},"reference-count":38,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T00:00:00Z","timestamp":1784246400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Immunol."],"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The concurrent circulation of influenza viruses and SARS\u2011CoV\u20112 continues to strain global public health systems. Vaccination remains the cornerstone of defense, and combined vaccines offer a strategic advantage by simplifying logistics, reducing costs, and improving coverage.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this set of studies, we evaluated the safety and immunogenicity of a novel combined quadrivalent influenza and recombinant COVID\u201119 vaccine (developed by Anhui Zhifei Longcom Biopharmaceutical Co., Ltd.), known as the Flu\u2011CoV2 vaccine, in Sprague\u2011Dawley rats. Three independent studies were conducted in accordance with ICH S6(R1) guidelines for Preclinical Safety Evaluation of Biotechnology\u2011Derived Pharmaceuticals: primary immunization (Study 1) and booster immunization following a prior history of either influenza (Study 2) or COVID\u201119 (Study 3) vaccination. Immunogenicity was determined by immunoglobulin G (IgG) antibody enzyme\u2011linked immunosorbent assay, plaque reduction neutralization tests for SARS\u2011CoV\u20112, and hemagglutination inhibition assays for influenza viruses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>No severe, life\u2011threatening, or fatal adverse reactions occurred during any of the studies. Transient injection\u2011site nodules in adjuvanted groups resolved completely, and all transient post\u2011vaccination shifts in hematologic and biochemical parameters normalized by the end of the recovery period. As a primary regimen, the Flu\u2011CoV2 vaccine effectively induced strong IgG and neutralizing antibody responses against both influenza and SARS\u2011CoV\u20112. Administered as a booster, it markedly augmented specific antibody levels in pre\u2011immune models, demonstrating its potential to broadly enhance recall immune responses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These preclinical data demonstrate a favorable safety profile and potent immunogenicity, supporting the further development of the Flu\u2011CoV2 vaccine as a promising tool to address the dual threat of influenza and COVID\u201119.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fimmu.2026.1849279","type":"journal-article","created":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T06:31:09Z","timestamp":1784269869000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Favorable safety and immunogenicity of a combined quadrivalent influenza and recombinant SARS-CoV-2 vaccine in 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