Safety and efficacy of one and two booster doses of SARS-CoV-2 mRNA vaccines in kidney transplant recipients: A randomized clinical trial
Jazyk angličtina Země Dánsko Médium print-electronic
Typ dokumentu randomizované kontrolované studie, časopisecké články
Grantová podpora
CZ.02.1.01/0.0/0.0/16_019/0000787
Charles University Cooperatio Program
00669806
Faculty Hospital in Pilsen
BBMRI-CZ: Biobank network
PubMed
37724748
DOI
10.1111/tid.14150
Knihovny.cz E-zdroje
- Klíčová slova
- COVID-19, SARS-CoV-2 mRNA vaccine, SARS-CoV-2 vaccination, kidney transplantation, randomized trial,
- MeSH
- COVID-19 * prevence a kontrola MeSH
- dospělí MeSH
- imunoglobulin G MeSH
- lidé MeSH
- mRNA vakcíny MeSH
- příjemce transplantátu MeSH
- protilátky virové MeSH
- SARS-CoV-2 MeSH
- transplantace ledvin * škodlivé účinky MeSH
- vakcína BNT162 MeSH
- vakcína firmy Moderna proti COVID-19 MeSH
- vakcíny proti COVID-19 škodlivé účinky MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- imunoglobulin G MeSH
- mRNA vakcíny MeSH
- protilátky virové MeSH
- vakcína BNT162 MeSH
- vakcína firmy Moderna proti COVID-19 MeSH
- vakcíny proti COVID-19 MeSH
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.
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