The development of effective SARS-CoV-2 mRNA vaccines has been a significant accomplishment. Adverse events are extremely rare, but continued surveillance is important, especially in at-risk populations. In 5-patients with preexisting immune dysregulation, hyperinflammatory syndromes, including hemophagocytic lymphohistiocytosis, developed after SARS-CoV-2 mRNA vaccination. Early recognition of this rare condition is essential.

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Background: We had previously conducted a double-blind, randomized placebo-controlled, partial cross-over trial showing that 12 weeks of dipyridamole decreased CD8+ T-cell activation among treated HIV(+) individuals by increasing extracellular adenosine levels. Methods: In this substudy, rectosigmoid biopsies were obtained from 18 participants (9 per arm), to determine whether 12 weeks of dipyridamole affects mucosal immune cells. Participants randomized to placebo were then switched to dipyridamole for 12 weeks while the treatment arm continued dipyridamole for another 12 weeks. We evaluated T-cell frequencies and plasma markers of microbial translocation and intestinal epithelial integrity. Linear regression models on log-transformed outcomes were used for the primary 12-week analysis. Results: Participants receiving dipyridamole had a median 70.2% decrease from baseline in regulatory T cells (P = 0.007) and an 11.3% increase in CD8+ T cells (P = 0.05). There was a nonsignificant 10.80% decrease in plasma intestinal fatty acid binding protein levels in the dipyridamole arm compared with a 9.51% increase in the placebo arm. There were no significant differences in plasma levels of β-d-glucan. In pooled analyses, there continued to be a significant decrease in regulatory T cells (−44%; P = 0.004). There was also a trend for decreased CD4+ and CD8+ T-cell activation. Conclusion: Increasing extracellular adenosine levels using dipyridamole in virally suppressed HIV (+) individuals on antiretroviral therapy can affect regulation of gut mucosal immunity.

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This study provides new insights into the contributions of different CD4 + and CD8 + T-cell subsets to the anatomic differences between LN and blood in individuals with HIV who have optimal versus suboptimal CD4 + T-cell recovery. To our knowledge, this is the first study comparing paired LN and blood CD4 + and CD8 + T-cell differentiation subsets, as well as those subsets in immunological responders versus immunological suboptimal responders.