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Results of the RENAISSANCE Study: REsponse to BNT162b2 COVID-19 vacciNe-short- And long-term Immune reSponSe evAluatioN in health Care workErs.
Pani, Arianna; Cento, Valeria; Vismara, Chiara; Campisi, Daniela; Di Ruscio, Federica; Romandini, Alessandra; Senatore, Michele; Schenardi, Paolo Andrea; Gagliardi, Oscar Matteo; Giroldi, Simona; Zoppini, Laura; Moreno, Mauro; Corradin, Matteo; Epis, Oscar Massimiliano; Ughi, Nicola; Cuppari, Irene; Crocchiolo, Roberto; Merli, Marco; Bosio, Marco; Rossini, Silvano; Puoti, Massimo; Scaglione, Francesco.
  • Pani A; Department of Oncology and Hemato-Oncology, Università degli Studi di Milano, Milan, Italy; Chemical-Clinical and Microbiological Analyses, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy. Electronic address: Arianna.pani@unimi.it.
  • Cento V; Department of Oncology and Hemato-Oncology, Università degli Studi di Milano, Milan, Italy; Chemical-Clinical and Microbiological Analyses, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Vismara C; Chemical-Clinical and Microbiological Analyses, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Campisi D; Chemical-Clinical and Microbiological Analyses, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Di Ruscio F; Postgraduate School of Microbiology and Virology, Università degli Studi di Milano, Milan, Italy; Chemical-Clinical and Microbiological Analyses, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Romandini A; Postgraduate School of Clinical Pharmacology and Toxicology, Università degli Studi di Milano, Milan, Italy.
  • Senatore M; Postgraduate School of Clinical Pharmacology and Toxicology, Università degli Studi di Milano, Milan, Italy; Chemical-Clinical and Microbiological Analyses, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Schenardi PA; Postgraduate School of Clinical Pharmacology and Toxicology, Università degli Studi di Milano, Milan, Italy.
  • Gagliardi OM; Postgraduate School of Clinical Pharmacology and Toxicology, Università degli Studi di Milano, Milan, Italy; Chemical-Clinical and Microbiological Analyses, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Giroldi S; Healthcare Management Department, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Zoppini L; Healthcare Management Department, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Moreno M; Healthcare Management Department, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Corradin M; Healthcare Management Department, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Epis OM; Rheumatology Unit, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Ughi N; Rheumatology Unit, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Cuppari I; Division of Immunohaematology and Transfusion Medicine, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Crocchiolo R; Division of Immunohaematology and Transfusion Medicine, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Merli M; Division of Infectious Diseases, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Bosio M; Healthcare Management Department, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Rossini S; Division of Immunohaematology and Transfusion Medicine, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Puoti M; Division of Infectious Diseases, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Scaglione F; Department of Oncology and Hemato-Oncology, Università degli Studi di Milano, Milan, Italy; Chemical-Clinical and Microbiological Analyses, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
Mayo Clin Proc ; 96(12): 2966-2979, 2021 12.
Article in English | MEDLINE | ID: covidwho-1504520
ABSTRACT

OBJECTIVE:

To evaluate the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) anti-spike (S) IgG antibody production after vaccination with BNT162b2 and the protection from symptomatic breakthrough infections in health care workers.

METHODS:

This prospective observational study (RENAISSANCE) had as a primary end point the evaluation of serologic response to BNT162b2 14 days after a second dose. SARS-CoV-2 anti-S IgG antibodies were evaluated with LIAISON SARS-CoV-2 TrimericS IgG assay (DiaSorin S.p.A.), which is able to detect the presence of both binding and neutralizing antibodies for trimeric spike glycoprotein. Participants were recruited from February 1, 2021, to February 22, 2021. Occurrence of vaccine breakthrough infections was assessed by reverse transcription-polymerase chain reaction on symptomatic and contact cases up to June 6, 2021.

RESULTS:

Of 2569 staff evaluated, only 4 were nonresponders (0.16%; 95% CI, 0.04% to 0.41%). All 4 nonresponders were severely immunosuppressed and receiving treatment with mycophenolate mofetil or mycophenolic acid. At 14 days after the second dose, 67.5% (1733) of staff had anti-S IgG titers of 2000 BAU/mL or higher; 19.2% (494), between 1500 and 2000 BAU/mL; 9.8% (251), between 1000 and 1500 BAU/mL; and 3.4% (87), 1000 BAU/mL or lower. Women had a higher probability of having higher titers than men (64.5% [1044/1618] vs 58.3% [410/703]; P=.005). This was confirmed after adjustment for age group (odds ratio, 1.275; 95% CI, 1.062 to 1.531; P=.009). Four months after the end of the vaccination program, only 13 participants (0.26%) had experienced a breakthrough SARS-CoV-2 infection, including 1 nonresponder. This was the only participant requiring hospitalization for severe COVID-19.

CONCLUSION:

The vaccination campaign among health care workers at the ASST GOM Niguarda has resulted in a marked serologic response and reduction of incident COVID-19 cases. Yet, the lack of protection should not be overlooked in immunocompromised individuals.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Health Personnel / COVID-19 Serological Testing / COVID-19 / BNT162 Vaccine / Immunity, Active Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study Topics: Long Covid / Vaccines / Variants Limits: Female / Humans / Male / Middle aged Country/Region as subject: Europa Language: English Journal: Mayo Clin Proc Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Health Personnel / COVID-19 Serological Testing / COVID-19 / BNT162 Vaccine / Immunity, Active Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study Topics: Long Covid / Vaccines / Variants Limits: Female / Humans / Male / Middle aged Country/Region as subject: Europa Language: English Journal: Mayo Clin Proc Year: 2021 Document Type: Article