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Randomized Controlled Trial
. 2023 Oct;25(5):e14150.
doi: 10.1111/tid.14150. Epub 2023 Sep 19.

Safety and efficacy of one and two booster doses of SARS-CoV-2 mRNA vaccines in kidney transplant recipients: A randomized clinical trial

Petr Drenko  1   2 , Martin Kacer  1   2 , Lukas Kielberger  1   2 , Tomas Vlas  2   3 , Ondrej Topolcan  4 , Radek Kucera  4   5 , Tomas Reischig  1   2
Affiliations
Randomized Controlled Trial

Safety and efficacy of one and two booster doses of SARS-CoV-2 mRNA vaccines in kidney transplant recipients: A randomized clinical trial

Petr Drenko et al. Transpl Infect Dis. 2023 Oct.

Abstract

Background: Kidney transplant recipients are at risk for a severe course of COVID-19 with a high mortality rate. A considerable number of patients remains without a satisfactory serological response after the baseline and adjuvant SARS-CoV-2 vaccination schedule.

Methods: In this prospective, randomized study, we evaluated the efficacy and safety of one and two booster doses of mRNA vaccines (either mRNA-1273 or BNT162b2) in 125 COVID-19 naive, adult kidney transplant recipients who showed an insufficient humoral response (SARS-CoV-2 IgG <10 AU/ml) to the previous 2-dose vaccination schedule. The primary outcome was the difference in the rate of a positive antibody response (SARS-CoV-2 IgG ≥10 AU/ml) between one and two booster doses at 1 month after the final booster dose.

Results: A positive humoral response was observed in 36 (62%) patients receiving two booster doses and in 28 (44%) patients receiving one booster dose (odds ratio [OR], 2.10, 95% confidence interval [CI], 1.02-4.34, p = .043). Moreover, median SARS-CoV-2 IgG levels were higher with two booster doses (p = .009). The number of patients with positive virus neutralizing antibody (VNA) levels was numerically higher with two booster doses compared to one booster dose, but without statistical significance (66% vs. 50%, p = .084). There was no significant difference in positive seroconversions rate and antibody levels between mRNA-1273 and BNT162b2.

Conclusion: A higher number of kidney transplant recipients achieved a positive antibody response after two booster doses compared to one booster dose.

Keywords: COVID-19; SARS-CoV-2 mRNA vaccine; SARS-CoV-2 vaccination; kidney transplantation; randomized trial.

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References

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