Evaluation of the SARS-CoV-2 Antibody Response to the BNT162b2 Vaccine in Patients Undergoing Hemodialysis

Yau, Kevin; Abe, Kento T.; Naimark, David; Oliver, Matthew J.; Perl, Jeffrey; Leis, Jerome A; Bolotin, Shelly; Tran, Vanessa; Mullin, Sarah; Shadowitz, Ellen; Gonzalez, Anny; Sukovic, Tatjana; Garnham-Takaoka, Julie; Launay, Keelia Quinn de; Takaoka, Alyson; Straus, Sharon E.; McGeer, Allison; Chan, Christopher T.; Colwill, Karen; Gingras, Anne‐Claude; Hladunewich, Michelle A.

doi:10.1001/jamanetworkopen.2021.23622

Cited by 54 publications

(49 citation statements)

References 16 publications

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“…A further study among hemodialysis patients observed that poor immunogenicity was generated at 28 days after a single dose of BNT162b2. Consequently, the second dose should be administered without any delay in this population [225]. Further research has also suggested that this vaccine is safe for youths and young adults having a previous history of acute lymphoblastic leukemia and allergy to PEG-asparaginase [226].…”

Section: Efficiency Of Vaccines Observed After Phase 3 Trialmentioning

confidence: 99%

A Systematic Review on COVID-19 Vaccine Strategies, Their Effectiveness, and Issues

Khandker¹,

Godman

Jawad

et al. 2021

Vaccines

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COVID-19 vaccines are indispensable, with the number of cases and mortality still rising, and currently no medicines are routinely available for reducing morbidity and mortality, apart from dexamethasone, although others are being trialed and launched. To date, only a limited number of vaccines have been given emergency use authorization by the US Food and Drug Administration and the European Medicines Agency. There is a need to systematically review the existing vaccine candidates and investigate their safety, efficacy, immunogenicity, unwanted events, and limitations. The review was undertaken by searching online databases, i.e., Google Scholar, PubMed, and ScienceDirect, with finally 59 studies selected. Our findings showed several types of vaccine candidates with different strategies against SARS-CoV-2, including inactivated, mRNA-based, recombinant, and nanoparticle-based vaccines, are being developed and launched. We have compared these vaccines in terms of their efficacy, side effects, and seroconversion based on data reported in the literature. We found mRNA vaccines appeared to have better efficacy, and inactivated ones had fewer side effects and similar seroconversion in all types of vaccines. Overall, global variant surveillance and systematic tweaking of vaccines, coupled with the evaluation and administering vaccines with the same or different technology in successive doses along with homologous and heterologous prime-booster strategy, have become essential to impede the pandemic. Their effectiveness appreciably outweighs any concerns with any adverse events.

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Section: Efficiency Of Vaccines Observed After Phase 3 Trialmentioning

confidence: 99%

A Systematic Review on COVID-19 Vaccine Strategies, Their Effectiveness, and Issues

Khandker¹,

Godman

Jawad

et al. 2021

Vaccines

View full text Add to dashboard Cite

show abstract

“…Although seroconversion rates in hemodialysis patients after two doses of SARS-CoV-2 vaccination have been reported well above the success rates of other conventional vaccination schemes e.g., for hepatitis B in this patient population, these response rates are still below those of the normal population [ 6 , 7 , 8 ]. The situation is further complicated by the fact that low-symptom infection courses have been reported in dialysis patients despite successful vaccination [ 9 , 10 ]. Furthermore, the questions as to which risk factors lead to a reduced response to vaccination in dialysis patients and whether a third booster-vaccination could lead to a successful formation of antibodies remain still unanswered.…”

Section: Introductionmentioning

confidence: 99%

Evolution of SARS-CoV-2-Neutralizing Antibodies after Two Standard Dose Vaccinations, Risk Factors for Non-Response and Effect of a Third Dose Booster Vaccination in Non-Responders on Hemodialysis: A Prospective Multi-Centre Cohort Study

Tillmann¹,

Figiel²,

Ricken

et al. 2021

JCM

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The aim of this investigation was to determine the effect of SARS-Cov-2 vaccination in hemodialysis patients, search for risk factors for non- or low-response, and to measure the effect of a third booster vaccination in non- or low-responders. Methods SARS-CoV-2 IgG antibodies and the virus-neutralizing capacity were measured 4–5 weeks after a full standard vaccination in 95 chronic hemodialysis patients and 60 controls. IgG titers > 30 AU/mL served to classify participants as responders. Multivariable binary logistic regression analysis was used to search for risk factors of reduced vaccination success. Patients with vaccination failure were offered a third booster dosage. Results 82.1% of the patient cohort as compared to 98.3% of the healthy control group were able to mount SARS-CoV-2 titers above 30 AU/mL after two standard vaccine doses. Mean IgG antibody titers were lower in hemodialysis patients than controls (78 ± 35 vs. 90 ± 20 AU/mL, p = 0.002). Multivariable binary logistic regression analysis showed age and immunosuppressive medication as major risk factors for vaccination failure with a decreased probability of successful vaccination of −6.1% (95% CI −1.2 to −10.9) per increase in age of one year and −87.4% (95% CI −98.0 to −21.5) in patients on immunosuppressive therapy (crude odds ratio for vaccination failure for immunosuppressive therapy 6.4). Ten out of 17 patients with non-response to vaccination were offered a third dose. Booster vaccination after the second dose induced an increase in effective antibody titers of >30 AU/mL in seven out of ten patients 4–5 weeks later (70%). Conclusion Standard SARS-CoV-2 vaccination schemes are highly effective in mounting protective neutralizing IgG antibodies in chronic hemodialysis patients. Nevertheless, response to vaccination is diminished as compared to a healthy control group. Major risk factors for vaccination failure are older age and immunosuppressive therapy. In non- or low-responders to standard vaccination a third booster vaccination was able to induce effective antibody titers in about 70% of patients, indicating that a third booster vaccination might be preferable to decreasing immunosuppressive therapy.

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“…To illustrate how vaccination cohorts differ from infected cohorts, we re‐plotted a subset of the data from our training set (positives and negatives) as pairwise comparisons of spike and N on scatterplots, with the color intensity mapping to that of RBD (Figure 5a ). We also replotted data from a cohort of vaccinated patients on dialysis 21 prior to vaccination and 6 weeks afterward (Figure 5b ). As expected, the infected cohort contained samples largely positive for all three antigens tested, while the vaccinated cohort largely consisted of samples positive for spike and its RBD, but negative for N, which is not targeted by vaccines used in Canada.…”

Section: Resultsmentioning

confidence: 99%

“…Based on, e.g. a weak response to vaccine in older adults or patients on dialysis, 21 , 39 or the decline in antibody levels post‐dose 2 in residents of long‐term care homes, 40 , 41 prioritisations were made for second doses, vaccine type was recommended, or additional doses were accelerated in the populations studied. Combined with other studies coordinated by the COVID‐19 Immunity Task Force (CITF), 42 our serology studies help guide Canada’s response to the COVID‐19 pandemic.…”

Section: Discussionmentioning

confidence: 99%

A scalable serology solution for profiling humoral immune responses to SARS‐CoV‐2 infection and vaccination

et al. 2022

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Objectives Antibody testing against severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) has been instrumental in detecting previous exposures and analyzing vaccine‐elicited immune responses. Here, we describe a scalable solution to detect and quantify SARS‐CoV‐2 antibodies, discriminate between natural infection‐ and vaccination‐induced responses, and assess antibody‐mediated inhibition of the spike‐angiotensin converting enzyme 2 (ACE2) interaction. Methods We developed methods and reagents to detect SARS‐CoV‐2 antibodies by enzyme‐linked immunosorbent assay (ELISA). The main assays focus on the parallel detection of immunoglobulin (Ig)Gs against the spike trimer, its receptor binding domain (RBD) and nucleocapsid (N). We automated a surrogate neutralisation (sn)ELISA that measures inhibition of ACE2‐spike or ‐RBD interactions by antibodies. The assays were calibrated to a World Health Organization reference standard. Results Our single‐point IgG‐based ELISAs accurately distinguished non‐infected and infected individuals. For seroprevalence assessment (in a non‐vaccinated cohort), classifying a sample as positive if antibodies were detected for ≥ 2 of the 3 antigens provided the highest specificity. In vaccinated cohorts, increases in anti‐spike and ‐RBD (but not ‐N) antibodies are observed. We present detailed protocols for serum/plasma or dried blood spots analysis performed manually and on automated platforms. The snELISA can be performed automatically at single points, increasing its scalability. Conclusions Measuring antibodies to three viral antigens and identify neutralising antibodies capable of disrupting spike‐ACE2 interactions in high‐throughput enables large‐scale analyses of humoral immune responses to SARS‐CoV‐2 infection and vaccination. The reagents are available to enable scaling up of standardised serological assays, permitting inter‐laboratory data comparison and aggregation.

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Evaluation of the SARS-CoV-2 Antibody Response to the BNT162b2 Vaccine in Patients Undergoing Hemodialysis

Cited by 54 publications

References 16 publications

A Systematic Review on COVID-19 Vaccine Strategies, Their Effectiveness, and Issues

A Systematic Review on COVID-19 Vaccine Strategies, Their Effectiveness, and Issues

Evolution of SARS-CoV-2-Neutralizing Antibodies after Two Standard Dose Vaccinations, Risk Factors for Non-Response and Effect of a Third Dose Booster Vaccination in Non-Responders on Hemodialysis: A Prospective Multi-Centre Cohort Study

A scalable serology solution for profiling humoral immune responses to SARS‐CoV‐2 infection and vaccination

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