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Vaccine Assessment: Serological Testing for Viral Vaccine Assessment

Fondazione Vismederi

12-weeks Program: Ideal for a full immersion and comprehensive experience in serological
techniques required from regulatory bodies (e.g. FDA, EMA, PMD) to license and approve viral
vaccines, with a specific focus on respiratory viruses (e.g. Influenza, SARS-CoV-2 and others). The
program will include a study of the various techniques (up to Biosecurity Containment 2) from
both a theoretical and practical point of view.

Main Areas of Interest

Immune response to viral vaccines and natural infections
Development and production of lentiviral pseudotypes
Immune response to influenza hemagglutinin (HA) and neuraminidase (NA) antigens
Multiplex assays (Luminex and MSD)
Overview of validation and qualification processes for serological assays

Specialties

Immunology

Microbiology

Public Health

Infectious Diseases

Global Health

Techniques You Will Learn

Enzyme-linked immunosorbent assay (ELISA) for detecting IgG, IgM, and IgA antibodies in human and animal serum samples
Lentiviral pseudotype platform: from design to production
Enzyme-linked lectin assay for titration of anti-neuraminidase functional antibodies in human and animal serum samples
Multiparametric assays: Meso Scale Diagnostics and Luminex for detecting antibodies against multiple antigen

Curriculum

VisMederi-srl is a private research and service company having its business in Siena (Italy) since 2009.
The core business of VisMederi relies in offering serological and immunological assay services to
pharmaceutical companies (including customized support) to assess the immunogenicity of new
vaccines, in compliance with the International Quality Standard UNI EN ISO 9001:2015; UNI CEI ISO/IEC
17025:2005 and UNI EN ISO 15189:2013. From more than 15 years, VisMederi routinely performs
analytical testing of biological samples derived from pre-clinical/clinical vaccine immunogenicity studies
and runs optimization/validation of bioanalytical methods for the pharmaceutical industry worldwide.
VisMederi offers full clinical trial and research project support from concept through to completion
based on high-quality standards, having in place a certified Quality Management System (QMS) that
follows international GCLP guidelines. Services provided include scientific, technical, and logistic
assistance for protocol design and review, samples analysis, data elaboration, release of results and
reporting.

VisMederi offers 12 weeks internship training providing a comprehensive induction and overview about
VisMederi and its work in the field of vaccines, Good Clinical Laboratory Practices (GCLP), the main
serological techniques to evaluate vaccine effectiveness along with quality aspects and data release.
During the internship the intern will learn some serological technique that are generally used to
evaluate the effectiveness of viral vaccines in general and, influenza vaccines specifically. Among these,
there will be the ELISA test, the Pseudo-types neutralization assay, a surrogate of the classic
neutralization assay performed with a non-infective particles customized in-house and that do not
require biosecurity containment, and an overview of the multiparameter testing such as Luminex and
MSD. In parallel to this, the intern will learn all the GCLP aspects in terms of Quality assurance and
documentation.

Accommodation

Try Airbnb.com
Hotel Arcobaleno Siena: Via Fiorentina, 32/40, 53100 Siena, SI | hotelarcobalenosiena.it
Soggiorno Lo Stellino: Via Fiorentina, 95/97, 53100 Siena, SI
Il Refugio: Via del Refugio, 4, 53100 Siena, SI | Residenza d’epoca situata nel cuore di Siena | ilrefugio.com

Fees and Program Logistics

This program has the following durations available:

Duration	Fee
12 weeks	$2,750.00

This program allows Merit Applications. This program allows merit-based applications for virtual and onsite clinical and research programs. If you are successfully awarded under this category, Trialect or the host mentor will cover the tuition fee only. All applications will be evaluated based on merit. Due to the high level of competition, the chances of being selected under the merit category are quite limited.

Who Can Apply

Biologists, Biotechnologist, Pharmaceutical chemistry and technology

Host Details

Host Name: Dott. Alessandro Manenti

Affiliation: Fondazione Vismederi

Address: Strada del Petriccio e Belriguardo 35 53100 Siena, Italy

Website URL: https://www.fondazionevismederi.org/

Disclaimer:It is mandatory that all applicants carry workplace liability insurance, e.g., https://www.protrip-world-liability.com (Erasmus students use this package and typically costs around 5 € per month - please check) in addition to health insurance when you join any of the onsite Trialect partnered fellowships.