An additional dose of viral vector COVID-19 vaccine and mRNA COVID-19 vaccine in kidney transplant recipients: A randomized controlled trial (CVIM 4 study)

Bruminhent, Jackrapong; Setthaudom, Chavachol; Phornkittikorn, Pattaraphorn; Chaumdee, Pongsathon; Prasongtanakij, Somsak; Srisala, Supanart; Malathum, Kumthorn; Boongird, Sarinya; Nongnuch, Arkom; Assanatham, Montira; Nakgul, Laor; Sanmeema, Nutaporn; Phuphuakrat, Angsana; Kiertiburanakul, Sasisopin

doi:10.1111/ajt.17151

Cited by 9 publications

(6 citation statements)

References 25 publications

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“…14,15 Several comparisons between viral vector vs. mRNA vaccines exist in SOT recipients; however, the results have been inconclusive. 16,17 Our study had several limitations. First, the primary outcome was immunogenicity as determined by using anti-SARS-CoV-2 spike-protein antibody, not the incidence of SARS-CoV-2 infection.…”

Section: Discussionmentioning

confidence: 95%

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Comparison of BNT162b2 and mRNA1273 vaccines in solid organ transplant recipients: Post‐Hoc analysis of a Japanese national prospective study

et al. 2023

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The coronavirus disease‐19 (COVID‐19) vaccine efficacy and immunogenicity in the immunocompetent population are well established. However, in solid organ transplant (SOT) recipients, because of their use of immunosuppressive medication, the immunogenicity of these severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) vaccines remains suboptimal. Both BNT162b2 and mRNA1273 have been used for some time, but their immunogenicity has not been directly compared in this immunocompromised patient group. We performed a post‐hoc analysis of a previous prospective cohort study. The inclusion criteria were adult SOT recipients with active grafts at least 1 month after SOT. After giving consent, participants chose to receive either BNT162b2 or mRNA1273 vaccine. Anti‐spike‐protein‐S antibody against SARS‐CoV‐2 was measured. Propensity scores were calculated via logistic regression to transform the probability of having received either BNT162b2 or mRNA1273 vaccine, and a model was developed. We enrolled 623 SOT recipients. In the propensity score‐matched analysis, 100 recipients were selected for BNT162b2 and 100 for mRNA1273. SARS‐CoV‐2 anti‐spike protein antibody positivity with BNT162b2 versus mRNA1273 at 3 weeks after the first dose, 1 month after the second dose, 3 months after the second dose, and 6 months after the second dose were 10% versus 19% (P = .07), 51% versus 58% (P = .30), 74% versus 88% (P = .01), and 78% versus 87% (P = .13), respectively. We conducted a propensity score‐matched comparison of BNT162b2 and mRNA1273 vaccines as the primary series of COVID‐19 vaccines in SOT recipients. We found significantly better immunogenicity with the mRNA1273 vaccine than with BNT162b2.

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Section: Discussionmentioning

confidence: 95%

“…The heterologous method was studied and showed some benefits 14,15 . Several comparisons between viral vector vs. mRNA vaccines exist in SOT recipients; however, the results have been inconclusive 16,17 …”

Section: Discussionmentioning

confidence: 99%

Comparison of BNT162b2 and mRNA1273 vaccines in solid organ transplant recipients: Post‐Hoc analysis of a Japanese national prospective study

et al. 2023

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“…In CVIM 4 study, a RCT of 85 KTRs, recipients who had been previously received primary series consisting of either two doses of CoronaVac or followed by one dose of ChAdOx1nCoV-19 vaccine or two doses of ChAdOx1 nCoV-19 vaccine were randomized to receive either an mRNA (M group; n = 43) or viral vector (V group; n = 42, ChAdOx1nCoV-19) booster. At 2 weeks post-additional dose, there was no difference in the measured B and T cell immune responses between the two groups ( 46 ).…”

Section: Heterologous Vaccination Strategymentioning

confidence: 99%

COVID-19 in kidney transplantation-implications for immunosuppression and vaccination

2022

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COVID-19 pandemic continues to challenge the transplant community, given increased morbidity and mortality associated with the disease and poor response to prevention measures such as vaccination. Transplant recipients have a diminished response to both mRNA and vector-based vaccines compared to dialysis and the general population. The currently available assays to measure response to vaccination includes commercially available antibody assays for anti-Spike Ab, or anti- Receptor Binding Domain Ab. Positive antibody testing on the assays does not always correlate with neutralizing antibodies unless the antibody levels are high. Vaccinations help with boosting polyfunctional CD4+ T cell response, which continues to improve with subsequent booster doses. Ongoing efforts to improve vaccine response by using additional booster doses and heterologous vaccine combinations are underway. There is improved antibody response in moderate responders; however, the ones with poor response to initial vaccination doses, continue to have a poor response to sequential boosters. Factors associated with poor vaccine response include diabetes, older age, specific immunosuppressants such as belatacept, and high dose mycophenolate. In poor responders, a decrease in immunosuppression can increase response to vaccination. COVID infection or vaccination has not been associated with an increased risk of rejection. Pre- and Post-exposure monoclonal antibodies are available to provide further protection against COVID infection, especially in poor vaccine responders. However, the efficacy is challenged by the emergence of new viral strains. A recently approved bivalent vaccine offers better protection against the Omicron variant.

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“…13,14 Likewise, another randomized trial showed no significant difference in immunogenic potential between homologous and heterologous vaccine regimen. 15 The fourth dose of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) vaccine in kidney recipients is safe and has potential to increase antibody titers to neutralizing levels in a relevant part of previous low-responders to the third dose. 16 However, only a marginal number of previously seronegative patients show an antibody response after the fourth dose (19%-42%).…”

Section: Introductionmentioning

confidence: 99%

“…However, in a direct comparison of the adenoviral vector (Ad26COVS) and mRNA (BNT162b2/mRNA‐1273) vaccine after two or three previous mRNA doses in kidney transplant recipients who remained seronegative, no significant difference in humoral and cellular response was observed 13,14 . Likewise, another randomized trial showed no significant difference in immunogenic potential between homologous and heterologous vaccine regimen 15 . The fourth dose of SARS‐CoV‐2 (severe acute respiratory syndrome coronavirus 2) vaccine in kidney recipients is safe and has potential to increase antibody titers to neutralizing levels in a relevant part of previous low‐responders to the third dose 16 .…”

Section: Introductionmentioning

confidence: 99%

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

Drenko,

Kacer,

Kielberger

et al. 2023

Transplant Infectious Dis

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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

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An additional dose of viral vector COVID-19 vaccine and mRNA COVID-19 vaccine in kidney transplant recipients: A randomized controlled trial (CVIM 4 study)

Cited by 9 publications

References 25 publications

Comparison of BNT162b2 and mRNA1273 vaccines in solid organ transplant recipients: Post‐Hoc analysis of a Japanese national prospective study

Comparison of BNT162b2 and mRNA1273 vaccines in solid organ transplant recipients: Post‐Hoc analysis of a Japanese national prospective study

COVID-19 in kidney transplantation-implications for immunosuppression and vaccination

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

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