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. 2024 Jun 17;12(6):665.
doi: 10.3390/vaccines12060665.

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

Joaquín Sáez-Peñataro  1 , Gonzalo Calvo  1 , Juan Bascuas  1 , Maria Mar Mosquera  2 , Maria Ángeles Marcos  2   3 , Natalia Egri  4 , Ferran Torres  5
Affiliations

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

Joaquín Sáez-Peñataro et al. Vaccines (Basel). .

Abstract

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: immunogenicity; mRNA vaccines; pharmacovigilance; reactogenicity; real-world data.

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Conflict of interest statement

None of the authors have any conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Flowchart of the study displaying the populations for the main analysis and sensitivity analyses.
Figure 2
Figure 2
Immunogenicity and reactogenicity results of the main population. Bar diagram of the results in Table 2. Immunogenicity is expressed as antibody positiveness (positive/negative titres) and antibody titres (antibody titres below/above median) data (%). Reactogenicity results are represented as a percentage of vaccinees developing each solicited AR.
Figure 3
Figure 3
Immunogenicity and reactogenicity results of sensitivity analysis 1. Bar diagram of the results in Table 3. Immunogenicity is expressed as antibody positiveness (positive/negative titres) and cellular immunogenicity (positive/negative) data (%). Reactogenicity results are represented as a percentage of vaccinees developing each solicited AR.
Figure 4
Figure 4
Immunogenicity and reactogenicity results of sensitivity analysis 2. Bar diagram of the results in Table 4. Immunogenicity is expressed as antibody positiveness (positive/negative titres) and antibody titres (antibody titres below/above median) data (%). Reactogenicity results are represented as a percentage of vaccinees developing each solicited AR.
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