Pregnancy surveillance and Zika disease: a surveillance methodology proposal for a Zika vaccine efficacy trial

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Introduction: Surveillance for suspected or confirmed cases of specific diseases allows for the capturing and classification of such cases for the assessment of efficacy in vaccine clinical trials. In the case of Zika Virus Disease surveillance there are major limitations, mainly due to the poorly characterized disease epidemiology and burden of the disease. In this paper we propose a surveillance method for the detection and follow-up of ZIKV infection in pregnant women and their infants up to 1 year of age to be used in the context of a phase III vaccine efficacy study.

Methods: A systematic review of the current validated national guidelines for Zika surveillance in pregnant women and newborns in three countries of Latin America (Brazil, Mexico and Colombia) and the USA was performed, including comparison. The guidelines of these four specific countries were taken into account because these were targeted for the efficacy trial. The analysis included a comparison between the documents and with those from other international and regional organizations (i.e. WHO-World Health Organization, CDC-Centers for Disease Control and Prevention). A consensus Surveillance Methodology document was drafted and shared with clinical experts on the topic in the selected countries; the background of these experts included neuropediatrics, pediatric infectious diseases, obstetrics/gynecology and perinatology.

Results: The group produced a proposal for a regional surveillance method for Zika virus disease for pregnant women and newborns that could be integrated into the assessment of cases for a vaccine efficacy phase III trial in Latin America, while being compliant
with national and regional public health authorities’ guidelines. This document proposes parameters for the identification of
probable Zika infection in pregnant women, ascertaining a probable Zika infection in the fetus and defines early findings of Congenital Zika Syndrome (CZS); for the follow-up of infants during the first year of life.

Conclusions: Vaccine efficacy trials should have strong disease/infection surveillance methodologies in place that enables the demonstration of the efficacy or futility of the intervention. In the case of a Zika vaccine candidate efficacy phase III trial, it is important to have a clear suspected clinical case definition for the identification of the cases under surveillance, laboratory tests that allows for their confirmation, as well as specific surveillance methods for subgroups of interest such as pregnant women and their children. All these actions will increase the likelihood for assessing the efficacy of a Zika vaccine candidate to prevent infection and disease.
Translated title of the contributionVigilancia del embarazo y enfermedad Zika: una propuesta metodológica de vigilancia para una prueba de eficacia de la vacuna Zika
Original languageEnglish (US)
Pages (from-to)61-68
Number of pages8
JournalRevista Latinoamericana de Infectología Pediátrica
Issue number2
StatePublished - Apr 1 2019

All Science Journal Classification (ASJC) codes

  • Infectious Diseases

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