fb3ac8024452883c38d1f66914776a49 pmc_11209257.pdf 178f2cc0fdb88d41781e73d67236abd8764d06dc pmc_11209257.pdf e52d134a919cfffe8a9a32f0c514afffb897dfea03a5a52211e1cc34bc5f8549 pmc_11209257.pdf Title: Association between Reactogenicity and Immunogenicity in a Vaccinated Cohort with Two mRNA SARS-CoV-2 Vaccines at a High-Complexity Reference Hospital: A Post Hoc Analysis on Immunology Aspects of a Prospective Cohort Study Subject: Enhancing our comprehension of mRNA vaccines may facilitate the future design of novel vaccines aimed at augmenting immune protection while minimising reactogenic responses. Before this design is carried out, it is important to determine whether adaptive immunity correlates with the reactogenicity profile of vaccines. We studied a large cohort that was vaccinated with mRNA vaccines to answer this question. This was an observational study with real-world data. Reactogenicity data were obtained from the VigilVacCOVID study. Immunogenicity (humoral and cellular) data were retrieved from health records. One main population (n = 215) and two subpopulations were defined (subpopulation 1, n = 3563; subpopulation 2, n = 597). Sensitivity analyses were performed with subpopulations 1 and 2 to explore the consistency of results. We analysed the association of the intensity and types of adverse reactions with the development and quantity of elicited antibody titres. As an exploratory analysis in subpopulation 1, we assessed the association between reactogenicity and cellular immunogenicity. A higher incidence of fever, malaise, and myalgia including severe cases was significantly associated with the development and quantity of positive antibody titres. No significant findings were observed with cellular immunity. We observed a positive association between immunogenicity and reactogenicity. These findings can be relevant for the future development of our understanding of how mRNA vaccines function. Keywords: mRNA vaccines; reactogenicity; immunogenicity; pharmacovigilance; real-world data Author: Joaquín Sáez-Peñataro, Gonzalo Calvo, Juan Bascuas, Maria Mar Mosquera, Maria Ángeles Marcos, Natalia Egri and Ferran Torres Creator: LaTeX with hyperref Producer: pdfTeX-1.40.25 CreationDate: Mon Jun 17 07:22:42 2024 CEST ModDate: Mon Jun 17 07:25:28 2024 CEST Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 24 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 1095833 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- YXDTOY+VnURWPalladioL-Bold Type 1 Custom yes yes yes 10 0 NWBRMH+URWPalladioL-Bold Type 1 Custom yes yes yes 16 0 VGMEFS+URWPalladioL-Roma Type 1 Custom yes yes yes 22 0 OKFVLT+URWPalladioL-Ital Type 1 Custom yes yes yes 27 0 RNQRXP+URWPalladioL-BoldItal Type 1 Custom yes yes yes 32 0 YQOTQA+VnURWPalladioL Type 1 Custom yes yes yes 37 0 GPNHML+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 91 0 GPNHNN+PalatinoLinotype TrueType WinAnsi yes yes no 94 0 GPNHNP+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 97 0 FJBUXO+CMSY10 Type 1 Builtin yes yes yes 107 0 GPNHML+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 138 0 GPNHNN+PalatinoLinotype TrueType WinAnsi yes yes no 141 0 GPNHNP+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 144 0 GPNMLE+Calibri CID TrueType Identity-H yes yes yes 147 0 GPNHML+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 175 0 GPNHNN+PalatinoLinotype TrueType WinAnsi yes yes no 178 0 GPNHNP+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 181 0 GPNMLE+Calibri CID TrueType Identity-H yes yes yes 184 0 GPNHML+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 212 0 GPNHNN+PalatinoLinotype TrueType WinAnsi yes yes no 215 0 GPNHNP+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 218 0 GPNMLE+Calibri CID TrueType Identity-H yes yes yes 221 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2024-09-01 08:12:32 CEST RepresentationInformation: pmc_11209257.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2024-07-18 02:30:08 CEST Size: 1095833 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 456 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Materials and Methods Destination: section.2 Children: Item: Title: Study Design and Collected Data Destination: subsection.2.1 Item: Title: Statistical Analysis Destination: subsection.2.2 Children: Item: Title: Sample Size Calculation and Planned Analyses Destination: subsubsection.2.2.1 Item: Title: Study Endpoints Destination: subsubsection.2.2.2 Item: Title: Statistical Analysis Destination: subsubsection.2.2.3 Item: Title: Results Destination: section.3 Children: Item: Title: Immunogenicity and Reactogenicity Results Destination: subsection.3.1 Children: Item: Title: Main Analysis (Main Population, N = 215) Destination: subsubsection.3.1.1 Item: Title: Sensitivity Analysis 1 (N = 3563) Destination: subsubsection.3.1.2 Item: Title: Sensitivity Analysis 2 (N = 597) Destination: subsubsection.3.1.3 Item: Title: Overall Reactogenicity and Immunogenicity Analysis Destination: subsubsection.3.1.4 Item: Title: Discussion Destination: section.4 Item: Title: Conclusions Destination: section.5 Item: Title: References Destination: appendix.A. Info: Title: Association between Reactogenicity and Immunogenicity in a Vaccinated Cohort with Two mRNA SARS-CoV-2 Vaccines at a High-Complexity Reference Hospital: A Post Hoc Analysis on Immunology Aspects of a Prospective Cohort Study Author: Joaquín Sáez-Peñataro, Gonzalo Calvo, Juan Bascuas, Maria Mar Mosquera, Maria Ángeles Marcos, Natalia Egri and Ferran Torres Subject: Enhancing our comprehension of mRNA vaccines may facilitate the future design of novel vaccines aimed at augmenting immune protection while minimising reactogenic responses. Before this design is carried out, it is important to determine whether adaptive immunity correlates with the reactogenicity profile of vaccines. We studied a large cohort that was vaccinated with mRNA vaccines to answer this question. This was an observational study with real-world data. Reactogenicity data were obtained from the VigilVacCOVID study. Immunogenicity (humoral and cellular) data were retrieved from health records. One main population (n = 215) and two subpopulations were defined (subpopulation 1, n = 3563; subpopulation 2, n = 597). Sensitivity analyses were performed with subpopulations 1 and 2 to explore the consistency of results. We analysed the association of the intensity and types of adverse reactions with the development and quantity of elicited antibody titres. As an exploratory analysis in subpopulation 1, we assessed the association between reactogenicity and cellular immunogenicity. A higher incidence of fever, malaise, and myalgia including severe cases was significantly associated with the development and quantity of positive antibody titres. No significant findings were observed with cellular immunity. We observed a positive association between immunogenicity and reactogenicity. These findings can be relevant for the future development of our understanding of how mRNA vaccines function. 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