Study protocol for the multicentre cohorts of Zika virus infection in pregnant women, infants, and acute clinical cases in Latin America and the Caribbean: the ZIKAlliance consortium - Aix-Marseille Université Access content directly
Journal Articles BMC Infectious Diseases Year : 2019

Study protocol for the multicentre cohorts of Zika virus infection in pregnant women, infants, and acute clinical cases in Latin America and the Caribbean: the ZIKAlliance consortium

Vivian Avelino-Silva
  • Function : Author
Adriana Tami
  • Function : Author
Kerstin Rosenberger
  • Function : Author
Luis Nacul
  • Function : Author
Aluisio Segurado
  • Function : Author
Moritz Pohl
  • Function : Author
Sarah Bethencourt
  • Function : Author
Isabelle Viana
  • Function : Author
Renata Rabello
  • Function : Author
Carmen Soria
  • Function : Author
Silvia Salgado
  • Function : Author
Pedro Martínez
  • Function : Author
Hugo López-Gatell
  • Function : Author
Jennifer Hegewisch-Taylor
  • Function : Author
Victor Borja-Aburto
  • Function : Author
César González
  • Function : Author
Eduardo Netto
  • Function : Author
Paola Saba Villarroel
  • Function : Author
Bruno Hoen
Ernesto Marques
  • Function : Author
Xavier de Lamballerie
  • Function : Author
  • PersonId : 952950

Abstract

Abstract Background The European Commission (EC) Horizon 2020 (H2020)-funded ZIKAlliance Consortium designed a multicentre study including pregnant women (PW), children (CH) and natural history (NH) cohorts. Clinical sites were selected over a wide geographic range within Latin America and the Caribbean, taking into account the dynamic course of the ZIKV epidemic. Methods Recruitment to the PW cohort will take place in antenatal care clinics. PW will be enrolled regardless of symptoms and followed over the course of pregnancy, approximately every 4 weeks. PW will be revisited at delivery (or after miscarriage/abortion) to assess birth outcomes, including microcephaly and other congenital abnormalities according to the evolving definition of congenital Zika syndrome (CZS). After birth, children will be followed for 2 years in the CH cohort. Follow-up visits are scheduled at ages 1–3, 4–6, 12, and 24 months to assess neurocognitive and developmental milestones. In addition, a NH cohort for the characterization of symptomatic rash/fever illness was designed, including follow-up to capture persisting health problems. Blood, urine, and other biological materials will be collected, and tested for ZIKV and other relevant arboviral diseases (dengue, chikungunya, yellow fever) using RT-PCR or serological methods. A virtual, decentralized biobank will be created. Reciprocal clinical monitoring has been established between partner sites. Substudies of ZIKV seroprevalence, transmission clustering, disabilities and health economics, viral kinetics, the potential role of antibody enhancement, and co-infections will be linked to the cohort studies. Discussion Results of these large cohort studies will provide better risk estimates for birth defects and other developmental abnormalities associated with ZIKV infection including possible co-factors for the variability of risk estimates between other countries and regions. Additional outcomes include incidence and transmission estimates of ZIKV during and after pregnancy, characterization of short and long-term clinical course following infection and viral kinetics of ZIKV. Study registrations clinicaltrials.gov NCT03188731 (PW cohort), June 15, 2017; clinicaltrials.gov NCT03393286 (CH cohort), January 8, 2018; clinicaltrials.gov NCT03204409 (NH cohort), July 2, 2017.

Dates and versions

hal-02619517 , version 1 (25-05-2020)

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Cite

Vivian Avelino-Silva, Philippe Mayaud, Adriana Tami, Maria Miranda, Kerstin Rosenberger, et al.. Study protocol for the multicentre cohorts of Zika virus infection in pregnant women, infants, and acute clinical cases in Latin America and the Caribbean: the ZIKAlliance consortium. BMC Infectious Diseases, 2019, 19 (1), ⟨10.1186/s12879-019-4685-9⟩. ⟨hal-02619517⟩

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