Safety and efficacy of the mRNA BNT162b2 vaccine against SARS-CoV-2 in five groups of immunocompromised patients and healthy controls in a prospective open-label clinical trial

Bergman, Peter; Blennow, Ola; Hansson, Lotta; Mielke, Stephan; Nowak, Piotr; Chen, Puran; Söderdahl, Gunnar; Österborg, Anders; Smith, C. I. Edvard; Wullimann, David; Vesterbacka, Jan; Lindgren, Georg; Blixt, Lisa; Friman, Gustav; Borgström, Erik; Nordlander, Anna; Cuapio, Angélica; Akber, Mira; Valentini, Davide; Norlin, Anna-Carin; Thalme, Anders; Bogdanović, Gordana; Muschiol, Sandra; Nilsson, Peter; Hober, Sophia; Loré, Karin; Chen, Margaret Sallberg; Buggert, Marcus; Ljunggren, Hans-Gustav; Ljungman, Per; Aleman, Soo

doi:10.1016/j.ebiom.2021.103705

Cited by 198 publications

(244 citation statements)

References 27 publications

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“…No serious topical or systemic side-effects were noted post vaccination in our cohort, like in most studies addressing this issue [10,11,37,38]. Notably, these side effects were comparable between PWLD, with or without cirrhosis, and controls.…”

Section: Discussionsupporting

confidence: 67%

Antibody Responses after SARS-CoV-2 Vaccination in Patients with Liver Diseases

Bakasis

Bitzogli

Mouziouras

et al. 2022

Viruses

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The novel mRNA-based vaccines against SARS-CoV-2 display encouraging safety and efficacy profiles. However, there is a paucity of data regarding their immunogenicity and safety in patients with liver diseases (PWLD), especially in those with cirrhosis. We prospectively assessed anti-SARS-CoV-2 S-spike IgG antibodies and neutralizing activity in fully vaccinated PWLD (n = 87) and controls (n = 40). Seroconversion rates were 97.4% (37/38) in cirrhotic PWLD, 87.8% (43/49) in non-cirrhotic PWLD and 100% (40/40) in controls. Adequate neutralizing activity was detected in 92.1% (35/38), 87.8% (43/49) and 100% (40/40) of cirrhotics, non-cirrhotics and controls, respectively. On multivariable analysis, immunosuppressive treatment was negatively correlated with anti-SARS-CoV-2 antibody titers (coefficient (SE): −2.716 (0.634), p < 0.001) and neutralizing activity (coefficient (SE): −24.379 (4.582), p < 0.001), while age was negatively correlated only with neutralizing activity (coefficient (SE): −0.31(0.14), p = 0.028). A total of 52 responder PWLD were reassessed approximately 3 months post-vaccination and no differences were detected in humoral responses between cirrhotic and non-cirrhotic PWLD. No significant side effects were noted post vaccination, while no symptomatic breakthrough infections were reported during a 6-month follow up. Overall, our study shows that m-RNA-based SARS-CoV-2 vaccines are safe and efficacious in PWLD. However, PWLD under immunosuppressive treatment and those of advanced age should probably be more closely monitored after vaccination.

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Section: Discussionsupporting

confidence: 67%

Antibody Responses after SARS-CoV-2 Vaccination in Patients with Liver Diseases

Bakasis

Bitzogli

Mouziouras

et al. 2022

Viruses

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“…As with any social need, a compromise is often required between the unmet needs of the vulnerable individuals and the general safety to the immunocompetent population. Poor vaccine responses, persisting after three doses, remain a serious problem for immunocompromised patients [122]. These individuals remain at risk for infection and disease and represent a significant population given the success of modern medicine to treat many oncologic and rheumatologic conditions with therapies that impair immunity.…”

Section: The Challenge Of Vaccine Non-respondersmentioning

confidence: 99%

Mucosal Vaccines, Sterilizing Immunity, and the Future of SARS-CoV-2 Virulence

Focosi¹,

Maggi

Casadevall

2022

Viruses

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Sterilizing immunity after vaccination is desirable to prevent the spread of infection from vaccinees, which can be especially dangerous in hospital settings while managing frail patients. Sterilizing immunity requires neutralizing antibodies at the site of infection, which for respiratory viruses such as SARS-CoV-2 implies the occurrence of neutralizing IgA in mucosal secretions. Systemic vaccination by intramuscular delivery induces no or low-titer neutralizing IgA against vaccine antigens. Mucosal priming or boosting, is needed to provide sterilizing immunity. On the other side of the coin, sterilizing immunity, by zeroing interhuman transmission, could confine SARS-CoV-2 in animal reservoirs, preventing spontaneous attenuation of virulence in humans as presumably happened with the endemic coronaviruses. We review here the pros and cons of each vaccination strategy, the current mucosal SARS-CoV-2 vaccines under development, and their implications for public health.

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“…The exact same rank order for these groups was found for serum regarding the risk for failure of seroconversion. 30 Within the patient groups, the attributable risk factors among disease-or treatment-specific parameters were also assessed. Notably, being in an early-phase post-HSCT transplantation was a strong negative predictor (OR, 19.2; p < 0.02).…”

Section: Assessment Of Negative Predictors For Salivary Igg Response ...mentioning

confidence: 99%

“…2021-000175-37) investigating the immunogenicity of the BNT162b2 vaccine in immunocompromised patients and healthy controls. 30 The aim of the present study was to investigate vaccine-induced humoral immunity in the oral cavity in the same cohort.…”

Section: Introductionmentioning

confidence: 99%

Salivary IgG to SARS-CoV-2 indicates seroconversion and correlates to serum neutralization in mRNA-vaccinated immunocompromised individuals

Healy

Chen

et al. 2022

Med

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Background Immunocompromised individuals are highly susceptible to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. Whether vaccine-induced immunity in these individuals involves oral cavity, a primary site of infection, is presently unknown. Methods Immunocompromised patients (n=404) and healthy controls (n=82) participated in a prospective clinical trial (NCT04780659) encompassing two doses of the mRNA BNT162b2 vaccine. Primary immunodeficiency (PID), secondary immunodeficiencies caused by human immunodeficiency virus (HIV) infection, allogeneic hematopoietic stem cell transplantation (HSCT)/chimeric antigen receptor T cell therapy (CAR-T), solid organ transplantation (SOT), and chronic lymphocytic leukemia (CLL) patients were included. Salivary and serum immunoglobulin G (IgG) reactivities to SARS-CoV-2 spike were measured by multiplex bead-based assays and Elecsys® Anti-SARS-CoV-2 S assay. Results IgG responses to SARS-CoV-2 spike antigens in saliva in HIV and HSCT/CAR-T groups were comparable to healthy controls after vaccination. The PID, SOT, and CLL patients had weaker responses, influenced mainly by disease parameters or immunosuppressants. Salivary responses correlated remarkably well with specific IgG titers and the neutralizing capacity in serum. Receiver operating characteristic curve analysis for the predictive power of salivary IgG yielded AUC=0.95, PPV=90.7% for entire cohort after vaccination. Conclusions Saliva conveys vaccine responses induced by mRNA BNT162b2. The predictive power of salivary Spike-IgG makes it highly suitable for screening vulnerable groups for revaccination. Findings. Knut and Alice Wallenberg Foundation, Erling Perssons family foundation, Region Stockholm, Swedish Research Council, Karolinska Institutet, Swedish Blood Cancer Foundation, PID patient organization of Sweden, Nordstjernan AB, Center for Medical Innovation (CIMED), Swedish Medical Research Council, Stockholm County Council (ALF).

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Safety and efficacy of the mRNA BNT162b2 vaccine against SARS-CoV-2 in five groups of immunocompromised patients and healthy controls in a prospective open-label clinical trial

Cited by 198 publications

References 27 publications

Antibody Responses after SARS-CoV-2 Vaccination in Patients with Liver Diseases

Antibody Responses after SARS-CoV-2 Vaccination in Patients with Liver Diseases

Mucosal Vaccines, Sterilizing Immunity, and the Future of SARS-CoV-2 Virulence

Salivary IgG to SARS-CoV-2 indicates seroconversion and correlates to serum neutralization in mRNA-vaccinated immunocompromised individuals

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