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

Abstract

BackgroundKidney 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.MethodsIn 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.ResultsA 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.ConclusionA higher number of kidney transplant recipients achieved a positive antibody response after two booster doses compared to one booster dose. image

The Long-Term Immunogenicity of mRNABNT162b Third Vaccine Dose in Solid Organ Transplant Recipients

“…Indeed, recent data suggest that monoclonal antibody prophylactic therapy elicits a strong humoral response against SARS-CoV-2 in SOT-Rs [ 48 , 49 , 50 ]. Finally, the use of mRNA booster vaccines has been shown to elicit a stronger and broader immune response to SARS-CoV-2 Omicron variants compared to the wild-type monovalent booster vaccines [ 51 , 52 ]. Therefore, we conclude that the ongoing longitudinal evaluation of SARS-CoV-2 humoral and cellular responses to mRNA-based vaccine in SOT-Rs might be valuable and necessary to allow the frequent re-evaluation of an ever-changing viral landscape in immunocompromised individuals.…”

SARS‐CoV‐2 mRNA vaccine: Sometimes life needs a boost

“…Drenko et al showed the formation of human leukocyte antigen antibodies in 11% of patients after the second booster dose. 5 However, the vast majority of these antibodies were not donorspecific and there were no changes in creatinine upon follow-up. Thus, the theoretical risk of rejection needs to be balanced by the risk of severe coronavirus disease 2019 (COVID-19) infection and its downstream effects of pneumonitis, acute kidney injury, and the potential for death in kidney transplant recipients where advanced age and multiple comorbidities may also increase risk of complications.…”

“…In this issue of Transplant Infectious Diseases, Drenko et al performed a randomized trial of one and two booster doses of SARS-CoV-2 monovalent mRNA vaccines in kidney transplant recipients. 5 The study participants had received two doses as their primary series almost 7 months prior and had not formed an antibody response. They had also not previously been infected with SARS-CoV-2.…”

“…The trial by Drenko et al was performed starting September 2021 and did not include previously infected patients. 5 However, it is estimated that a large proportion of the global population has now been infected at least once with SARS-CoV-2. 12 This may be the case with transplant recipients also.…”