Detection, viral load and phylogenetic analysis of SARS-CoV-2 in samples of volunteers from the vaccine ChAdOx1 nCoV-19 clinical trial

• Grant number: 20/13381-6
• Support Opportunities: Regular Research Grants
• Start date: April 01, 2021
• End date: March 31, 2023
• Field of knowledge: Biological Sciences - Microbiology
• Principal Investigator: Nancy Cristina Junqueira Bellei
• Grantee: Nancy Cristina Junqueira Bellei
• Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil

Abstract

In 2019, a new coronavirus, SARS-CoV-2, was recognized as the cause of an outbreak of respiratory syndrome, COVID-19, causing millions of deaths worldwide, thus reaching pandemic status. Given this scenario, several vaccines are being developed, with emphasis on the vaccine ChAdOx1 nCoV-19 (AZD1222), developed by the Oxford Jenner Institute, in the University of Oxford, United Kingdom, the first one to start phase III clinical trials which started in Brazil, in June this year. In this study, voluntary participants are randomly divided into two groups. One group receives the ChAdOx1 nCoV-19 vaccine and another group (control) receives the vaccine for Meningitis. During the period of one year, vaccinated participants who present symptoms will be invited to collect nasopharyngeal and oropharyngeal swabs in order to detect SARS-CoV-2 by RT-PCR in real time. The samples will also be tested for other respiratory viruses including Influenza A and B, Respiratory Syncytial Virus, Rhinovirus and Adenovirus for differential diagnosis, contributing to epidemiological surveillance data, as well as observation of possible cases of co-infection. Positive samples will also be subjected to new generation sequencing (NGS), allowing the investigation of evolution events, mutation analysis, possible events that favor gain-of-function and trace the origin of the SARS-CoV-2 variants in the immunized population. From the molecular results and data obtained from the patients, statistical analysis will be performed by the Two-way ANOVA test using Graphpad Prism version 8.0, considering statistically different a p value <0.05. (AU)