TY - JOUR
T1 - Study protocol for the multicentre cohorts of Zika virus infection in pregnant women, infants, and acute clinical cases in Latin America and the Caribbean
T2 - The ZIKAlliance consortium
AU - Avelino-Silva, Vivian I.
AU - Mayaud, Philippe
AU - Tami, Adriana
AU - Miranda, Maria C.
AU - Rosenberger, Kerstin D.
AU - Alexander, Neal
AU - Nacul, Luis
AU - Segurado, Aluisio
AU - Pohl, Moritz
AU - Bethencourt, Sarah
AU - Villar, Luis A.
AU - Viana, Isabelle F.T.
AU - Rabello, Renata
AU - Soria, Carmen
AU - Salgado, Silvia P.
AU - Gotuzzo, Eduardo
AU - Guzmán, María G.
AU - Martínez, Pedro A.
AU - López-Gatell, Hugo
AU - Hegewisch-Taylor, Jennifer
AU - Borja-Aburto, Victor H.
AU - Gonzalez, Cesar
AU - Netto, Eduardo M.
AU - Saba Villarroel, Paola M.
AU - Hoen, Bruno
AU - Brasil, Patrícia
AU - Marques, Ernesto T.A.
AU - Rockx, Barry
AU - Koopmans, Marion
AU - De Lamballerie, Xavier
AU - Jaenisch, Thomas
AU - Jaenisch, Thomas
AU - Rosenberger, Kerstin Daniela
AU - Morales, Ivonne
AU - Tobian, Frank
AU - Uhlmann, Lorenz
AU - Pohl, Moritz
AU - Schretzmann, Julius
AU - Leege, Annika
AU - Viana, Isabelle F.T.
AU - Lins, Roberto D.
AU - Brasil, Patrícia
AU - De Filippis, Ana Maria Bispo
AU - Duarte, Ana Claudia Machado
AU - De Melo Espíndola, Otavio
AU - Bonaldo, Myrna
AU - Rabello, Renata
AU - Damasceno, Luana
AU - Avelino-Silva, Vivian
AU - Segurado, Aluisio
AU - Sabino, Ester
AU - Mendes-Correa, Maria Cassia
AU - Nacul, Luis
AU - Alexander, Neal
AU - Tami, Adriana
AU - Bethencourt, Sarah
AU - Falcon, Cristel
AU - Rodríguez, Egri
AU - Matos, Victmar
AU - Tinedo, Maria José
AU - La Rosa, Yenifer
AU - Murillo, Marianela
AU - Villar, Luis Angel
AU - Miranda, Maria Consuelo
AU - Lozano, Anyela
AU - Herrera, Victor Mauricio
AU - Gomez, Adriana
AU - Gelvez, Rosa Margarita
AU - Ortiz, Ricardo
AU - Soria, Carmen
AU - Dimitrakis, Lady
AU - Salgado, Silvia Paola
AU - Arrata, Mary Regato
AU - Allison, Humberto Guerra
AU - Talledo, Michael
AU - Villarroel, Paola Mariela Saba
AU - Torres, Eric Martínez
AU - Guzmán, María G.
AU - Martínez Rodríguez, Pedro A.
AU - Vera, Mayling Alvarez
AU - Santana, Belkis Galindo
AU - Reyes, Alicia
AU - Álvarez, Silvia Serrano
AU - Dorticós, Diana Ferriol
AU - Hegewisch-Taylor, Jennifer
AU - Alpuche-Aranda, Celia
AU - López-Gatell, Hugo
AU - González-Diaz, Esteban
AU - Pavía-Ruz, Norma
AU - Borja-Aburto, Victor Hugo
AU - Gonzalez, Cesar
AU - Grajales, Concepción
AU - Rojas, Teresita
AU - Arriaga, Lumumba
AU - Vallejos, Alfonso
AU - Hoen, Bruno
AU - Tynevez, Dominique
AU - De Lamballerie, Xavier
AU - Thirion, Laurence
AU - Drexler, Jan Felix
AU - Rockx, Barry
AU - Van Gorp, Eric
N1 - Publisher Copyright:
© 2019 The Author(s).
PY - 2019/12/26
Y1 - 2019/12/26
N2 - 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.
AB - 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.
KW - Arboviruses
KW - Caribbean
KW - Children
KW - Cohort
KW - Congenital abnormalities
KW - Latin America
KW - Mosquito-borne viruses
KW - Natural history
KW - Pregnant women
KW - Risk
KW - Vector-borne viruses
KW - Zika
UR - http://www.scopus.com/inward/record.url?scp=85077245947&partnerID=8YFLogxK
U2 - 10.1186/s12879-019-4685-9
DO - 10.1186/s12879-019-4685-9
M3 - Artículo Científico
C2 - 31878895
AN - SCOPUS:85077245947
SN - 1471-2334
VL - 19
JO - BMC Infectious Diseases
JF - BMC Infectious Diseases
IS - 1
M1 - 1081
ER -