Alessandro Torelli

VisMederi Research

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Emanuele Montomoli

University of Siena

Elena Gianchecchi

VisMederi Research

Giulia Piccini

VisMederi Research

Alessandro Manenti

VisMederi Research

Simona Piccirella

VisMederi Research

Inesa Hyseni

VisMederi Research

Marta Maggetti

Istituto Zooprofilattico Sperimentale dell'Abruzzo e del Molise G. Caporale

Rino Rappuoli

University of Siena

Pietro Piu

University of Siena

Maria Maddalena Plazzi

Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani

Cooperative Institutions

VisMederi Research

University of Siena

Istituti di Ricovero e Cura a Carattere Scientifico

Łukasiewicz Research Network – PORT Polish Center for Technology Development

Toscana Life Sciences

Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani

Wroclaw Research Centre EIT+ (Poland)

Ludwik Hirszfeld Institute of Immunology and Experimental Therapy

Center for Prevention and Treatment of Infections

Siena Biotech (Italy)

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Yellow Fever: Origin, Epidemiology, Preventive Strategies and Future Prospects

Vaccines (2022)

Elena Gianchecchi Virginia Cianchi Alessandro Torelli Emanuele Montomoli

Yellow fever (YF) virus still represents a major threat in low resource countries in both South America and Africa despite the presence of an effective vaccine. YF outbreaks are not only due to insufficient vaccine coverage for insufficient vaccine supply, but also to the increase in people without history of vaccination living in endemic areas. Globalization, continuous population growth, urbanization associated with inadequate public health infrastructure, and climate changes constitute important promoting factors for the spread of this virus to tropical and subtropical areas in mosquito-infested regions capable of spreading the disease. In the present review, we focus on the origin of the virus and its transmission, representing two debated topics throughout the nineteenth century, going deeply into the history of YF vaccines until the development of the vaccine still used nowadays. Besides surveillance, we highlight the urgent need of routine immunization and vaccination campaigns associated to diverse and innovative mosquito control technologies in endemic areas for YF virus in order to minimize the risk of new YF outbreaks and the global burden of YF in the future.

Pandemic

10.3390/vaccines10030372

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Citations (49)

Immunogenicity and Safety of the New Inactivated Quadrivalent Influenza Vaccine Vaxigrip Tetra: Preliminary Results in Children ≥6 Months and Older Adults

Vaccines (2018)

Emanuele Montomoli Alessandro Torelli Ilaria Manini Elena Gianchecchi

Since the mid-1980s, two lineages of influenza B viruses have been distinguished. These can co-circulate, limiting the protection provided by inactivated trivalent influenza vaccines (TIVs). This has prompted efforts to formulate quadrivalent influenza vaccines (QIVs), to enhance protection against circulating influenza B viruses. This review describes the results obtained from seven phase III clinical trials evaluating the immunogenicity, safety, and lot-to-lot consistency of a new quadrivalent split-virion influenza vaccine (Vaxigrip Tetra®) formulated by adding a second B strain to the already licensed TIV. Since Vaxigrip Tetra was developed by means of a manufacturing process strictly related to that used for TIV, the data on the safety profile of TIV are considered supportive of that of Vaxigrip Tetra. The safety and immunogenicity of Vaxigrip Tetra were similar to those of the corresponding licensed TIV. Moreover, the new vaccine elicits a superior immune response towards the additional strain, without affecting immunogenicity towards the other three strains. Vaxigrip Tetra is well tolerated, has aroused no safety concerns, and is recommended for the active immunization of individuals aged ≥6 months. In addition, preliminary data confirm its immunogenicity and safety even in children aged 6–35 months and its immunogenicity in older subjects (aged 66–80 years).

10.3390/vaccines6010014

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Citations (22)

Innovative Oral Iron Supplement (Sucrosomial Iron®) Is Able to Downregulate Hepcidin Release during Inflammation: In Vitro Study

Blood (2015)

Germano Tarantino Elisa Brilli Giulio Giordano Alessandro Torelli Francesco Equitani

Ferroportin

10.1182/blood.v126.23.4563.4563

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Citations (5)

Evaluation of SARS‐CoV‐2 neutralizing antibodies using a CPE‐based colorimetric live virus micro‐neutralization assay in human serum samples

Journal of Medical Virology (2020)

Alessandro Manenti Marta Maggetti Elisa Casa Donata Martinuzzi Alessandro Torelli

The micro-neutralization assay is a fundamental test in virology, immunology, vaccine assessment, and epidemiology studies. Since the SARS-CoV-2 outbreak at the end of December 2019 in China, it has become extremely important to have well-established and validated diagnostic and serological assays for this new emerging virus. Here, we present a micro-neutralization assay with the use of SARS-CoV-2 wild type virus with two different methods of read-out. We evaluated the performance of this assay using human serum samples taken from an Italian seroepidemiological study being performed at the University of Siena, along with the human monoclonal antibody CR3022 and some iper-immune animal serum samples against Influenza and Adenovirus strains. The same panel of human samples have been previously tested in enzyme-linked immunosorbent assay (ELISA) as a pre-screening. Positive, borderline, and negative ELISA samples were evaluated in neutralization assay using two different methods of read-out: subjective (by means of an inverted optical microscope) and objective (by means of a spectrophotometer). Our findings suggest that at least 50% of positive ELISA samples are positive in neutralization as well, and that method is able to quantify different antibody concentrations in a specific manner. Taken together, our results confirm that the colorimetric cytopathic effect-based microneutralization assay could be used as a valid clinical test method for epidemiological and vaccine studies.

Cytopathic effect

10.1002/jmv.25986

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Citations (179)

Safety and serum distribution of anti-SARS-CoV-2 monoclonal antibody MAD0004J08 after intramuscular injection

Nature Communications (2022)

Simone Lanini Stefano Milleri Emanuele Andreano Sarah Nosari Ida Paciello

The emerging threat represented by SARS-CoV-2 variants, demands the development of therapies for better clinical management of COVID-19. MAD0004J08 is a potent Fc-engineered monoclonal antibody (mAb) able to neutralize in vitro all current SARS-CoV-2 variants of concern (VoCs) including the omicron variant even if with significantly reduced potency. Here we evaluated data obtained from the first 30 days of a phase 1 clinical study (EudraCT N.: 2020-005469-15 and ClinicalTrials.gov Identifier: NCT04932850). The primary endpoint evaluated the percentage of severe adverse events. Secondary endpoints evaluated pharmacokinetic and serum neutralization titers. A single dose administration of MAD0004J08 via intramuscular (i.m.) route is safe and well tolerated, resulting in rapid serum distribution and sera neutralizing titers higher than COVID-19 convalescent and vaccinated subjects. A single dose administration of MAD0004J08 is also sufficient to effectively neutralize major SARS-CoV-2 variants of concern (alpha, beta, gamma and delta). MAD0004J08 can be a major advancement in the prophylaxis and clinical management of COVID-19.

2019-20 coronavirus outbreak

Intramuscular injection

10.1038/s41467-022-29909-x

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The use of cell-mediated immunity for the evaluation of influenza vaccines: an upcoming necessity

Human Vaccines & Immunotherapeutics (2019)

Elena Gianchecchi Alessandro Torelli Emanuele Montomoli

Influenza vaccines are a fundamental tool for preventing the disease and reducing its consequences, particularly in specific high-risk groups. In order to be licensed, influenza vaccines have to meet strict criteria established by European Medicines Agency. Although the licensure of influenza vaccines started 65 years ago, Hemagglutination Inhibition and Single Radial Hemolysis are the only serological assays that can ascertain correlates of protection. However, they present evident limitations. The present review focuses on the evaluation of cell-mediated immunity (CMI), which plays an important role in the host immune response in protecting against virus-related illness and in the establishment of long-term immunological memory. Although correlates of protection are not currently available for CMI, it would be advisable to investigate this kind of immunological response for the evaluation of next-generation vaccines.

Licensure

Hemagglutination assay

10.1080/21645515.2019.1565269

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Citations (34)

FightingNeisseria meningitidis: past and current vaccination strategies

Expert Review of Vaccines (2016)

Giulia Piccini Alessandro Torelli Elena Gianchecchi Simona Piccirella Emanuele Montomoli

Neisseria meningitidis infections represent a serious health problem that can lead to invasive meningococcal disease (IMD), a life-threatening condition associated with significant morbidity and mortality. IMD could however be preventable via vaccination. During the past five decades, vaccines against N. meningitidis capsular groups A, C, W and Y were introduced into the market. Recently, group B vaccines based on N. meninigitidis recombinant antigens and outer membrane vesicles have been developed and novel vaccine candidates are under evaluation. Areas covered: In this review we discuss the main meningococcal vaccines available, with focus on immunogenicity data, vaccination impact on disease burden and persistence of vaccine-induced immune response. Preliminary results on new vaccine formulations, potentially able to provide multi-group coverage, are also reported. Expert commentary: Continuous surveillance and optimization of national immunization programs are required in order not only to promptly fight future outbreaks but also to identify possible changes in N. meningitidis epidemiology.

Meningococcal vaccine

Reverse vaccinology

10.1080/14760584.2016.1187068

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Citations (13)

Antibodies specific to SARS-CoV-2 proteins N, S and E in COVID-19 patients in the normal population and in historical samples

Journal of General Virology (2021)

Aleksander Szymczak Natalia Jędruchniewicz Alessandro Torelli Agata Kaczmarzyk-Radka Rosa Coluccio

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread globally; recognition of immune responses to this virus will be crucial for coronavirus disease 2019 (COVID-19) control, prevention and treatment. We comprehensively analysed IgG and IgA antibody responses to the SARS-CoV-2 nucleocapsid protein (N), spike protein domain 1 (S1) and envelope protein (E) in: SARS-CoV-2-infected patient, healthy, historical and pre-epidemic samples, including patients’ medical, epidemiological and diagnostic data, virus-neutralizing capability and kinetics. N-specific IgG and IgA are the most reliable diagnostic targets for infection. Serum IgG levels correlate to IgA levels. Half a year after infection, anti-N and anti-S1 IgG decreased, but sera preserved virus-inhibitory potency; thus, testing for IgG may underestimate the protective potential of antibodies. Historical and pre-epidemic sera did not inhibit SARS-CoV-2, thus its circulation before the pandemic and a protective role from antibodies pre-induced by other coronaviruses cannot be confirmed by this study

Coronavirus

Pandemic

10.1099/jgv.0.001692

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Citations (22)

Interlaboratory Reproducibility of Standardized Hemagglutination Inhibition Assays

mSphere (2022)

David C. Bibby Michael Savanovic Jinrong Zhang Alessandro Torelli Rienk E. Jeeninga

Licensure of influenza vaccines relies on the hemagglutination inhibition (HI) assay as the primary method to determine quantitative functional antibody titers. The HI assay is also widely used for influenza virus surveillance, characterization, and epidemiology studies.

Hemagglutination assay

Multiplex

Antibody titer

10.1128/msphere.00953-21

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Citations (8)

Influenza Anti-Stalk Antibodies: Development of a New Method for the Evaluation of the Immune Responses to Universal Vaccine

Vaccines (2020)

Alessandro Manenti Agnieszka Katarzyna Macioła Claudia Maria Trombetta Otfried Kistner Elisa Casa

Growing interest in universal influenza vaccines and novel administration routes has led to the development of alternative serological assays that are able to detect antibodies against conserved epitopes. We present a competitive ELISA method that is able to accurately determine the ratio of serum immunoglobulin G directed against the different domains of the hemagglutinin, the head and the stalk. Human serum samples were treated with two variants of the hemagglutinin protein from the A/California/7/2009 influenza virus. The signals detected were assigned to different groups of antibodies and presented as a ratio between head and stalk domains. A subset of selected sera was also tested by hemagglutination inhibition, single radial hemolysis, microneutralization, and enzyme-linked lectin assays. Pre-vaccination samples from adults showed a quite high presence of anti-stalk antibodies, and the results were substantially in line with those of the classical serological assays. By contrast, pre-vaccination samples from children did not present anti-stalk antibodies, and the majority of the anti-hemagglutinin antibodies that were detected after vaccination were directed against the head domain. The presented approach, when supported by further assays, can be used to assess the presence of specific anti-stalk antibodies and the potential boost of broadly protective antibodies, especially in the case of novel universal influenza vaccine approaches.

Hemagglutination assay

Stalk

10.3390/vaccines8010043

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Citations (11)