Abstract
Background
The reactogenicity and immunogenicity of Coronavirus 2019 (COVID-19) vaccines is well-studied. Little is known regarding the relationship between immunogenicity and reactogenicity of COVID-19 vaccines.
Methods
This study assessed the association between immunogenicity and reactogenicity after two mRNA-1273 (100 µg) injections in 1671 total adolescent and adult participants (≥12 years) from the primary immunogenicity sets of the blinded per iods of the Coronavirus Efficacy (COVE) and TeenCOVE trials. Associations between immunogenicity through day 57 and solicited ARs after the first and second injections of mRNA-1273 were evaluated among participants with and without solicited ARs using linear mixed-effects models.
Results
The mRNA-1273 reactogenicity in this combined analysis set was similar to that reported for these trials. The vaccine elicited high neutralizing antibody (nAb) geometric mean titers (GMTs) in evaluable participants. GMTs at day 57 were significantly higher in participants who experienced solicited systemic ARs after the second injection (1227.2 [1164.4-1293.5]) than those who did not (980.1 [886.8-1083.2], p = 0.001) and were associated with fever, chills, headache, fatigue, myalgia, and arthralgia. Significant associations with local ARs were not found.
Conclusions
These data show an association of systemic ARs with increased nAb titers following a second mRNA-1273 injection. While these data indicate systemic ARs are associated with increased antibody titers, high nAb titers were observed in participants after both injections, consistent with the immunogenicity and efficacy in these trials. These results add to the body of evidence regarding the relationship of immunogenicity and reactogenicity and can contribute toward the design of future mRNA vaccines.
Δεν υπάρχουν σχόλια:
Δημοσίευση σχολίου