Safety of COVID-19 Vaccination in Immune-Deficient Patients Receiving Supplemental Immunoglobulin Therapies

Squire, Jacqueline D.; Joshi, Avni Y.

doi:10.1007/s10875-021-01101-8

Cited by 9 publications

(8 citation statements)

References 5 publications

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“…We did not observe de novo or relapses of ITP in the postvaccine observation period, while for instance a relapse has been observed during SARS-CoV-2 infection in our PID cohort [50]. Since some AEs of vaccines such as ITP are immune-mediated, it is possible that use of immunoglobulin replacement therapy in PID patients may provide some risk reduction against these adverse effects by its immunomodulatory effect [51].…”

Section: Discussionmentioning

confidence: 53%

Safety of mRNA COVID-19 Vaccines in Patients with Inborn Errors of Immunity: an Italian Multicentric Study

et al. 2022

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Purpose Little is known about vaccine safety in inborn errors of immunity (IEI) patients during the current vaccination campaign for COVID-19. To better investigate the reactogenicity and adverse event profile after two, three, and four doses of mRNA vaccines, we conducted an observational, multicentric study on 342 PID patients from four Italian Referral Centres. Methods We conducted a survey on self-reported adverse reactions in IEI patients who received mRNA vaccine by administering a questionnaire after each dose. Results Over the whole study period, none of the patients needed hospitalization or had hypersensitivity reactions, including anaphylaxis and delayed injection site reaction. After two vaccination doses, 35.4% of patients showed only local reactogenicity-related symptoms (RrS), 44.4% reported both systemic and local RrS, and 5% reported only systemic RrS. In more than 60% of cases, local or systemic RrS were mild. After the first and second booster doses, patients showed fewer adverse events (AEs) than after the first vaccination course. Patients aged 50 years and older reported adverse events and RrS less frequently. Among AEs requiring treatment, one common variable immune deficiency patient affected by T cell large granular lymphocytic leukemia developed neutropenia and one patient had Bell’s paralysis perhaps during herpes zoster reactivation. Conclusion Although our follow-up period is relatively short, the safety data we reported are reassuring. This data would help to contrast the vaccine hesitancy often manifested by patients with IEI and to better inform their healthcare providers.

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Section: Discussionmentioning

confidence: 53%

Safety of mRNA COVID-19 Vaccines in Patients with Inborn Errors of Immunity: an Italian Multicentric Study

et al. 2022

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“…Here, we characterized the immune responses elicited in 23 SARS-CoV-2-naïve PAD patients after receiving three mRNA-1273 vaccine doses. While our PAD cohort is mainly composed of unPAD and CVID patients, it includes one CID and TID patient, which might be interesting due to the limited information about how these patients respond to COVID-19 vaccination [22,23]. According with previous reports [10,23], our results showed that immunization was safe, and most patients developed Spike-speci c immune responses.…”

Section: Discussionmentioning

confidence: 54%

“…While our PAD cohort is mainly composed of unPAD and CVID patients, it includes one CID and TID patient, which might be interesting due to the limited information about how these patients respond to COVID-19 vaccination [22,23]. According with previous reports [10,23], our results showed that immunization was safe, and most patients developed Spike-speci c immune responses. However, while our results regarding humoral responses in PAD patients are similar to previous studies [10-12, 22, 24], there are several factors (i.e.…”

Section: Discussionmentioning

confidence: 54%

Kinetics of immune responses elicited after three mRNA COVID-19 vaccine doses in predominantly antibody-deficient individuals.

Ainsua-Enrich¹,

Pedreño-López²,

Bracke³

et al. 2022

Preprint

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Purpose Mass vaccination campaigns have reduced the incidence and severity of COVID-19. However, there is limited information about how patients with predominantly antibody-deficiencies (PAD) respond to COVID-19 vaccination. Here, we evaluated humoral and cellular responses developed in SARS-CoV-2-naïve PAD individuals after three mRNA-1273 vaccine doses. Methods Patients and healthy controls (HCs) were immunized at week 0 (w0) and w4. PAD individuals received an additional dose at w24. Blood samples were collected at w0, w4, w8, w24, and/or w28. We determined levels of anti-Spike and anti-RBD antibodies, Spike-specific IgG avidity, and neutralizing activity (Wuhan-Hu-1, Delta, and Omicron variants). Cellular responses were evaluated by IFN-γ ELISpot and flow cytometry. Results Unclassified primary antibody-deficiency patients (unPAD, n = 9) and HCs developed comparable vaccine-induced humoral responses. However, common variable immunodeficiency patients (CVID, n = 12) showed lower antibody responses than HCs. While the frequency of Spike-specific CD4 + T cells was similar between PAD patients and HCs, CD8 + T cells responses were reduced in CVID individuals. Both PAD groups showed lower levels of Spike-specific IFN-γ-producing T-cells. Combined immunodeficiency (CID, n = 1) and thymoma with immunodeficiency (TID, n = 1) patients developed cellular but not humoral responses after two immunizations. The third vaccine dose boosted humoral responses in most PAD patients, but had little effect on cellular immunity. Conclusion mRNA-1273 vaccine-induced immune responses in PAD individuals are heterogeneous, depend on the type and degree of antibody-deficiency, and should be immunomonitored to define a personalized vaccination strategy.

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“…mRNA vaccines are generally safe for healthy and immunocompromised people with cancer, autoimmune diseases, or organ transplant patients [14,15,26,27]. Moreover, currently used anti-SARS-CoV-2 vaccines seem to be safe in IEI patients [28][29][30][31][32]. Delmonte et al [31] did not report any adverse event in 81 IEI patients vaccinated with the mRNA and Johnson & Johnson's vec-tor vaccines.…”

Section: Discussion/conclusionmentioning

confidence: 99%

Immunogenicity and Safety of the Spikevax® (Moderna) mRNA SARS-CoV-2 Vaccine in Patients with Primary Humoral Immunodeficiency

Kralickova¹,

Jankovicova²,

Sejkorova³

et al. 2022

Int Arch Allergy Immunol

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Introduction: Reports on the immunogenicity and efficacy of the Spikevax® vaccine against SARS-CoV-2 in immunodeficient patients are still scarce. We aimed to evaluate the safety and immunogenicity of the vaccine in patients with primary humoral immunodeficiency. Methods: We enrolled 46 patients, including 34 patients with common variable immunodeficiency (CVID), 10 patients with unclassified hypogammaglobulinemia (HypoIg), and 2 patients with X-linked agammaglobulinemia. We collected the blood samples before vaccination (D 0), and 10 days (D +38) and 90 days (D +118) after the second vaccination. Further, we quantified SARS-CoV-2-specific T-cell response (QuantiFERON ELISA test), serum anti-RBD IgG, and anti-RBD IgA-specific antibodies (enzyme immunoassay). Results: We found that the vaccination elicited predominantly mild adverse events, comparable to healthy population. Vaccination response negatively correlated with a value of Immune Deficiency and Dysregulation Activity in all measured parameters. D +38, seroconversion for anti-RBD IgG and anti-RBD IgA was observed in 65% and 21% CVID patients, respectively. SARS-CoV-2-specific T-cell response was detected in less than 50% of CVID patients. Meanwhile, HypoIg patients had 100%, 90%, and 60% positivity rates for anti-RBD IgG, anti-RBD IgA, and T-cell response, respectively. Three months after the second vaccination, 82% of the responders remained positive for anti-RBD IgG, but only less than 50% remained positive for T-cell activity in CVIDs. Low immunogenicity was observed in patients with lung involvement and/or rituximab treatment history. No SARS-CoV-2 infection was reported within 6 months after the second vaccination. Conclusion: Spikevax® seems to be safe with satisfactory immunogenicity in patients with primary humoral immunodeficiency.

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Safety of COVID-19 Vaccination in Immune-Deficient Patients Receiving Supplemental Immunoglobulin Therapies

Cited by 9 publications

References 5 publications

Safety of mRNA COVID-19 Vaccines in Patients with Inborn Errors of Immunity: an Italian Multicentric Study

Safety of mRNA COVID-19 Vaccines in Patients with Inborn Errors of Immunity: an Italian Multicentric Study

Kinetics of immune responses elicited after three mRNA COVID-19 vaccine doses in predominantly antibody-deficient individuals.

Immunogenicity and Safety of the Spikevax® (Moderna) mRNA SARS-CoV-2 Vaccine in Patients with Primary Humoral Immunodeficiency

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