SEROLOGICAL EVOLUTION OF PRIMARY INFECTION BY EPSTEIN-BARR VIRUS IN CHILDREN

Study identification

• EU PAS number:
  EUPAS32464
• Study ID:
  32465
• Official title and acronym:
  SEROLOGICAL EVOLUTION OF PRIMARY INFECTION BY EPSTEIN-BARR VIRUS IN CHILDREN
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  The aim of this study was to know epidemiological, clinical and laboratory characteristics of primary infection by Epstein-Barr virus (EBV) in healthy children from our region. In a second prospective phase, we assessed serological and clinical evolution after primary infection and calculated the probability of not creating antibodies to a Epstein-Barr Nuclear Antigen (EBNA).We included patients with positive or indeterminate results of the EBV-VCA IgM test over a period of 22 months. We included cases identified through the Microbiology Laboratory which is the regional referral laboratory coordinating services for the public health catch-ment área of Xàtiva-Ontinyent in the province of Valencia in Spain, with a population of 204.623 inhabitants (2013 census) of whom 30.636 were aged less tan 15 years. We collected epidemiological, clinical and laboratory data from electronic health records following the protocol for data access and confidentiality of our hospital. Then, we visited patients at 6, 12, 18 and 24 months after the primary infection by EBV. We reported clinical and serological data from blood tests (VCA IgM, VCA IgG, EBNA IgG, Early Antigen IgG) in each visit, and according to the results, DNA detection by PCR test at 12,18 and 24 months after infection.
• Study status:
  Finalised

Research institutions and networks

Institutions

Health Department Xàtiva-Ontinyent

Study timelines

Date when funding contract was signed

Actual:09/01/2013

Study start date

Actual:01/02/2013

Data analysis start date

Actual:19/06/2017

Date of final study report

Actual:17/09/2018

Sources of funding

Other

More details on funding

Health Department Xàtiva-Ontinyent

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable