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

  • Funded by Fundação de Amparo à Pesquisa do Estado de São Paulo [São Paulo Research Foundation] (FAPESP)
  • Total publications:0 publications

Grant number: 20/13381-6

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Key facts

  • Disease

    COVID-19, Unspecified
  • Start & end year

    2021
    2023
  • Funder

    Fundação de Amparo à Pesquisa do Estado de São Paulo [São Paulo Research Foundation] (FAPESP)
  • Principal Investigator

    Nancy Cristina Junqueira Bellei
  • Research Location

    Brazil
  • Lead Research Institution

    Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil
  • Research Priority Alignment

    N/A
  • Research Category

    Pathogen: natural history, transmission and diagnostics

  • Research Subcategory

    Pathogen genomics, mutations and adaptations

  • Special Interest Tags

    N/A

  • Study Type

    Clinical

  • Clinical Trial Details

    Unspecified

  • Broad Policy Alignment

    Pending

  • Age Group

    Adults (18 and older)

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Unspecified

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)