A prospective observational study for justification, safety, and efficacy of a third dose of mRNA vaccine in patients receiving maintenance hemodialysis

Espi, M.; Charmetant, Xavier; Barba, Thomas; Mathieu, Cyrille; Pelletier, C.; Koppe, Laetitia; Chalencon, É.; Kalbacher, Emilie; Mathias, Virginie; Ovize, Anne; Cart-Tanneur, Emmanuelle; Bouz, Christine; Pellegrina, Laurence; Morélon, Emmanuel; Juillard, Laurent; Fouque, Denis; Couchoud, Cécile; Thaunat, Olivier; François, Clément; Mathilde, Reydit; Aurelien, Tiple,; Clémence, Béchade,; Bemrah, Abdelkader; Cécile, Vigneau; Bénédicte, Sautenent; Kazes, Isabelle; Courivaud, Cécile; Jean-Marc, Gabriel; Edet, Stéphane; Mercadal, Lucile; Moranne, Olivier; Fatouma, Toure; Laurain, Emmanuelle; Alex, Ranlin,; Longlune, Nathalie; Guilhot, François; Jean-Michel, Tivollier; Brunet, Philippe; Lavainne, Frédéric; Bérard, Emilie; Sarraj, Ayman; Marc, Bauwens; Testevuide, Pascale; Henri, Vacher Coponat; Rb, Galland; Nicole, Schauder; Rachid, Salmi Louis; Cerasuolo, Damiano; Anaïs, Tendron-Franzin; Sahar, Bayat; Michel, Halimi Jean; Aurore, Wolak; Gentile, Stéphanie; Devictor, Bénédicte; Monnet, Élisabeth; Denis, Boucaut Maitre; Nacher, Mathieu; Véronique, Merle; Jean-Philippe, Jais; Jean-Pierre, Daures; Vergnenègre, A.; Loos-Ayav, Carole; Merle, Sylvie; Hazzan, Marc; Gervolino, Shirley; Jean-Michel, Nguyen; Iacobelli, Simona

doi:10.1016/j.kint.2021.10.040

Cited by 76 publications

(105 citation statements)

References 26 publications

(24 reference statements)

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“…Overall, antibody titers, which are an important factor in protection from a severe infection course, improved significantly after 3D in HD patients, even in low/non-responder HD patients. This result contradicts the finding of 8 , where antibody titers in high responders did not improve significantly; however, the study’s cut-off for low/non-responders was higher than in our design.…”

Section: Discussioncontrasting

confidence: 99%

“…Importantly, a subgroup of HD patients were low/non-responders. The T cell interferon gamma (INF-γ) response in HD patients after vaccination has not been characterized very well, although some studies 8 aim to improve our knowledge on this topic. In Austria, a third dose (3D) of vaccine has been recommended due to the decline of vaccine-induced antibodies and the rise of COVID-19 cases 9 .…”

Section: Introductionmentioning

confidence: 99%

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Severe Acute Respiratory Coronavirus-2 Antibody and T cell response after a third vaccine dose in hemodialysis patients compared with healthy controls

Simon¹,

Rubey²,

Gromann

et al. 2022

Preprint

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1. Abstract Hemodialysis patients (HD patients) have a high health risk from Severe Acute Respiratory Coronavirus-2 (SARS CoV 2) infection. In this study, we assess the impact of a third vaccine dose (3D) on antibody levels and T cell response in HD patients and compare the results to those of a healthy control group. We conducted a prospective cohort study consisting of 60 HD patients and 65 healthy controls. All of them received two doses of the Comirnaty mRNA vaccine and a third mRNA vaccine dose (Spikevax or Comirnaty). The SARS CoV 2 S antibody response in all participants was measured 6 months after the second vaccine dose and 6 to 8 weeks after administration of the 3D. We also assessed INF-γ secretion 6 to 8 weeks after the 3D in 24 healthy controls, 17 HD patients with a normal and 20 HD patients with a low or no antibody response after the second dose. The groups were compared using univariate quantile regressions and multiple analyses. The adverse effects of vaccines were assessed via a questionnaire. After the 3D, the SARS CoV 2-specific antibody and INF-γ titers of most HD patients were comparable to those of healthy controls. A subgroup of HD patients who had shown a diminished antibody response after the first two vaccine doses developed a significantly lower antibody and INF-γ response compared to responder HD patients and controls, even after the 3D. A new strategy is needed to protect this patient group from severe COVID 19 infection.

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Section: Discussioncontrasting

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Severe Acute Respiratory Coronavirus-2 Antibody and T cell response after a third vaccine dose in hemodialysis patients compared with healthy controls

Simon¹,

Rubey²,

Gromann

et al. 2022

Preprint

View full text Add to dashboard Cite

show abstract

“…Our findings support the need of an additional boost, preferentially with a high-dose mRNA vaccine, in this population [62][63][64][65][66][67], which, however, need to be continuously monitored with proper serological tests that measure not only the serum antibody levels, but also their neutralizing activity, either directly or indirectly through an avidity test. Finally, our data suggest that some patients may not respond efficiently even after an additional boost and, therefore, in case of SARS-CoV-2 infection, they should be considered for other therapeutic strategies, including early immunotherapy with monoclonal antibodies.…”

Section: Discussionsupporting

confidence: 70%

Poor neutralization and rapid decay of antibodies to SARS-CoV-2 variants in vaccinated dialysis patients

Bassi

Giannini

Silacci-Fregni

et al. 2021

Preprint

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Patients on dialysis are at risk of severe course of SARS-CoV-2 infection. Understanding the neutralizing activity and coverage of SARS-CoV-2 variants of vaccine-elicited antibodies is required to guide prophylactic and therapeutic COVID-19 interventions in this frail population. By analyzing plasma samples from 130 hemodialysis (HD) and 13 peritoneal dialysis patients after two doses of BNT162b2 or mRNA-1273 vaccines, we found that 35% of the patients had low-level or undetectable IgG antibodies to SARS-CoV-2 Spike (S). Neutralizing antibodies against the vaccine-matched SARS-CoV-2 and Delta variant were low or undetectable in 49% and 77% of patients, respectively, and were further reduced against other emerging variants. The fraction of non-responding patients was higher in SARS-CoV-2-naive HD patients immunized with BNT162b2 (66%) than those immunized with mRNA-1273 (23%). The reduced neutralizing activity correlated with low antibody avidity, consistent with a delayed affinity maturation of SARS-CoV-2 S-specific B cells. These data indicate that dialysis patients should be considered for an additional boost and other therapeutic strategies, including early immunotherapy with monoclonal antibodies.

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“…In conclusion, our study demonstrates, at the functional level, that mRNA vaccines induce a poor neutralizing and rapidly decaying antibody response against SARS-CoV-2 variants in dialysis patients, in particular in naïve HD patients immunized with BNT162b2. Our findings support the need of an additional boost, preferentially with a high-dose mRNA vaccine, in this population [62][63][64][65][66][67], which, however, need to be continuously monitored with proper serological tests that measure not only the serum antibody levels, but also their neutralizing activity, either directly or indirectly through an avidity test. Finally, our data suggest that some patients may not respond efficiently even after an additional boost and, therefore, in case of SARS--CoV-2 infection, they should be considered for other therapeutic strategies, including early immunotherapy with monoclonal antibodies.…”

Section: Plos Onesupporting

confidence: 70%

Poor neutralization and rapid decay of antibodies to SARS-CoV-2 variants in vaccinated dialysis patients

et al. 2022

View full text Add to dashboard Cite

Patients on dialysis are at risk of severe course of SARS-CoV-2 infection. Understanding the neutralizing activity and coverage of SARS-CoV-2 variants of vaccine-elicited antibodies is required to guide prophylactic and therapeutic COVID-19 interventions in this frail population. By analyzing plasma samples from 130 hemodialysis and 13 peritoneal dialysis patients after two doses of BNT162b2 or mRNA-1273 vaccines, we found that 35% of the patients had low-level or undetectable IgG antibodies to SARS-CoV-2 Spike (S). Neutralizing antibodies against the vaccine-matched SARS-CoV-2 and Delta variant were low or undetectable in 49% and 77% of patients, respectively, and were further reduced against other emerging variants. The fraction of non-responding patients was higher in SARS-CoV-2-naïve hemodialysis patients immunized with BNT162b2 (66%) than those immunized with mRNA-1273 (23%). The reduced neutralizing activity correlated with low antibody avidity. Patients followed up to 7 months after vaccination showed a rapid decay of the antibody response with an average 21- and 10-fold reduction of neutralizing antibodies to vaccine-matched SARS-CoV-2 and Delta variant, which increased the fraction of non-responders to 84% and 90%, respectively. These data indicate that dialysis patients should be prioritized for additional vaccination boosts. Nevertheless, their antibody response to SARS-CoV-2 must be continuously monitored to adopt the best prophylactic and therapeutic strategy.

show abstract

A prospective observational study for justification, safety, and efficacy of a third dose of mRNA vaccine in patients receiving maintenance hemodialysis

Cited by 76 publications

References 26 publications

Severe Acute Respiratory Coronavirus-2 Antibody and T cell response after a third vaccine dose in hemodialysis patients compared with healthy controls

Severe Acute Respiratory Coronavirus-2 Antibody and T cell response after a third vaccine dose in hemodialysis patients compared with healthy controls

Poor neutralization and rapid decay of antibodies to SARS-CoV-2 variants in vaccinated dialysis patients

Poor neutralization and rapid decay of antibodies to SARS-CoV-2 variants in vaccinated dialysis patients

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