tetano
Editor, Senior Moderator
J Allergy Clin Immunol Pract
. 2022 Nov 12;S2213-2198(22)01191-6.
doi: 10.1016/j.jaip.2022.10.046. Online ahead of print.
Clinical outcomes, immunogenicity, and safety of BNT162b22 Vaccine in Primary Antibody Deficiency
Tomas Milota[SUP] 1 [/SUP], Jitka Smetanova[SUP] 2 [/SUP], Aneta Skotnicova[SUP] 3 [/SUP], Michal Rataj[SUP] 2 [/SUP], Jan Lastovicka[SUP] 2 [/SUP], Hana Zelena[SUP] 4 [/SUP], Zuzana Parackova[SUP] 2 [/SUP], Martina Fejtkova[SUP] 3 [/SUP], Veronika Kanderova[SUP] 3 [/SUP], Eva Fronkova[SUP] 3 [/SUP], Katerina Rejlova[SUP] 3 [/SUP], Anna Sediva[SUP] 2 [/SUP], Tomas Kalina[SUP] 3 [/SUP]
Affiliations
Abstract
Background: Common variable immunodeficiency (CVID) is characterized by an impaired post-vaccination response, high susceptibility to respiratory tract infections, and a broad spectrum of non-infectious complications. Thus, patients with CVID may be at high risk of coronavirus disease (COVID-19), and vaccination's role in prevention is questionable.
Objective: We evaluated the clinical outcomes, safety, and dynamics of humoral and T-cell immune responses induced by the mRNA vaccine BNT162b2 in CVID.
Methods: This prospective observational cohort study focused on the clinical outcomes (proportion of infected patients, disease severity), safety (adverse-event incidence, laboratory-parameter changes), and dynamics of humoral (specific post-vaccination and virus-neutralizing-antibody assessment) and T-cell immune responses (anti-SARS-CoV-2 specific T-cell detection) in 21 patients with CVID after a two-dose administration of BNT162b2. The patients were followed for 6 months.
Results: Humoral response was observed in 52% (11/21) of patients at month 1 post-vaccination but continuously decreased to 33.3% (5/15) at month 6. Nevertheless, they had a remarkably lower anti-SARS-CoV-2 neutralizing antibody titer than healthy controls. The T-cell response was measurable in 33% (6/17) of patients with CVID at month 1, and it persisted for the study period. Mild infection occurred in three patients (14.3%) within the follow-up period. The vaccine also exhibited a favorable safety profile.
Conclusions: The BNT162b2 vaccine elicited a measurable antibody response in a high proportion of patients, but it was limited by low titer of the virus-neutralizing antibodies and rapid waning of anti-RBD SARS-CoV-2 specific antibodies. T-cell response was detected in one-third of the patients and remained stable within the follow-up period. Vaccination has favorable safety and clinical-related outcomes in preventing severe COVID-19.
Keywords: COVID-19; Common variable immunodeficiency; Immunogenicity; Post-vaccination response; Safety; mRNA Vaccine.
. 2022 Nov 12;S2213-2198(22)01191-6.
doi: 10.1016/j.jaip.2022.10.046. Online ahead of print.
Clinical outcomes, immunogenicity, and safety of BNT162b22 Vaccine in Primary Antibody Deficiency
Tomas Milota[SUP] 1 [/SUP], Jitka Smetanova[SUP] 2 [/SUP], Aneta Skotnicova[SUP] 3 [/SUP], Michal Rataj[SUP] 2 [/SUP], Jan Lastovicka[SUP] 2 [/SUP], Hana Zelena[SUP] 4 [/SUP], Zuzana Parackova[SUP] 2 [/SUP], Martina Fejtkova[SUP] 3 [/SUP], Veronika Kanderova[SUP] 3 [/SUP], Eva Fronkova[SUP] 3 [/SUP], Katerina Rejlova[SUP] 3 [/SUP], Anna Sediva[SUP] 2 [/SUP], Tomas Kalina[SUP] 3 [/SUP]
Affiliations
- PMID: 36379409
- DOI: 10.1016/j.jaip.2022.10.046
Abstract
Background: Common variable immunodeficiency (CVID) is characterized by an impaired post-vaccination response, high susceptibility to respiratory tract infections, and a broad spectrum of non-infectious complications. Thus, patients with CVID may be at high risk of coronavirus disease (COVID-19), and vaccination's role in prevention is questionable.
Objective: We evaluated the clinical outcomes, safety, and dynamics of humoral and T-cell immune responses induced by the mRNA vaccine BNT162b2 in CVID.
Methods: This prospective observational cohort study focused on the clinical outcomes (proportion of infected patients, disease severity), safety (adverse-event incidence, laboratory-parameter changes), and dynamics of humoral (specific post-vaccination and virus-neutralizing-antibody assessment) and T-cell immune responses (anti-SARS-CoV-2 specific T-cell detection) in 21 patients with CVID after a two-dose administration of BNT162b2. The patients were followed for 6 months.
Results: Humoral response was observed in 52% (11/21) of patients at month 1 post-vaccination but continuously decreased to 33.3% (5/15) at month 6. Nevertheless, they had a remarkably lower anti-SARS-CoV-2 neutralizing antibody titer than healthy controls. The T-cell response was measurable in 33% (6/17) of patients with CVID at month 1, and it persisted for the study period. Mild infection occurred in three patients (14.3%) within the follow-up period. The vaccine also exhibited a favorable safety profile.
Conclusions: The BNT162b2 vaccine elicited a measurable antibody response in a high proportion of patients, but it was limited by low titer of the virus-neutralizing antibodies and rapid waning of anti-RBD SARS-CoV-2 specific antibodies. T-cell response was detected in one-third of the patients and remained stable within the follow-up period. Vaccination has favorable safety and clinical-related outcomes in preventing severe COVID-19.
Keywords: COVID-19; Common variable immunodeficiency; Immunogenicity; Post-vaccination response; Safety; mRNA Vaccine.