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 I Avelino-Silva, Philippe Mayaud, Adriana Tami, Maria C Miranda, Kerstin D Rosenberger, Neal Alexander, Luis Nacul, Aluisio Segurado, Moritz Pohl, Sarah Bethencourt, Luis A Villar, Isabelle F T Viana, Renata Rabello, Carmen Soria, Silvia P Salgado, Eduardo Gotuzzo, María G Guzmán, Pedro A Martínez, Hugo López-Gatell, Jennifer Hegewisch-Taylor, Victor H Borja-Aburto, Cesar Gonzalez, Eduardo M Netto, Paola M Saba Villarroel, Bruno Hoen, Patrícia Brasil, Ernesto T A Marques, Barry Rockx, Marion Koopmans, Xavier de Lamballerie, Thomas Jaenisch, ZIKAlliance Clinical Study Group, Thomas Jaenisch, Kerstin Daniela Rosenberger, Ivonne Morales, Frank Tobian, Lorenz Uhlmann, Moritz Pohl, Julius Schretzmann, Annika Leege, Ernesto T A Marques, Isabelle F T Viana, Roberto D Lins, Patrícia Brasil, Ana Maria Bispo de Filippis, Ana Claudia Machado Duarte, Otavio de Melo Espíndola, Myrna Bonaldo, Renata Rabello, Luana Damasceno, Vivian Avelino-Silva, Aluisio Segurado, Ester Sabino, Maria Cassia Mendes-Correa, Luis Nacul, Neal Alexander, Eduardo Martins Netto, Adriana Tami, Sarah Bethencourt, Cristel Falcon, Egri Rodríguez, Victmar Matos, Maria José Tinedo, Yenifer La Rosa, Marianela Murillo, Luis Angel Villar, Maria Consuelo Miranda, Anyela Lozano, Victor Mauricio Herrera, Adriana Gomez, Rosa Margarita Gelvez, Ricardo Ortiz, Carmen Soria, Lady Dimitrakis, Silvia Paola Salgado, Mary Regato Arrata, Eduardo Gotuzzo, Humberto Guerra Allison, Michael Talledo, Paola Mariela Saba Villarroel, Eric Martínez Torres, María G Guzmán, Pedro A Martínez Rodríguez, Mayling Alvarez Vera, Belkis Galindo Santana, Alicia Reyes, Silvia Serrano Álvarez, Diana Ferriol Dorticós, Jennifer Hegewisch-Taylor, Celia Alpuche-Aranda, Hugo López-Gatell, Esteban González-Diaz, Norma Pavía-Ruz, Victor Hugo Borja-Aburto, Cesar Gonzalez, Concepción Grajales, Teresita Rojas, Lumumba Arriaga, Alfonso Vallejos, Bruno Hoen, Dominique Tynevez, Xavier de Lamballerie, Laurence Thirion, Jan Felix Drexler, Barry Rockx, Eric van Gorp, Marion Koopmans, Vivian I Avelino-Silva, Philippe Mayaud, Adriana Tami, Maria C Miranda, Kerstin D Rosenberger, Neal Alexander, Luis Nacul, Aluisio Segurado, Moritz Pohl, Sarah Bethencourt, Luis A Villar, Isabelle F T Viana, Renata Rabello, Carmen Soria, Silvia P Salgado, Eduardo Gotuzzo, María G Guzmán, Pedro A Martínez, Hugo López-Gatell, Jennifer Hegewisch-Taylor, Victor H Borja-Aburto, Cesar Gonzalez, Eduardo M Netto, Paola M Saba Villarroel, Bruno Hoen, Patrícia Brasil, Ernesto T A Marques, Barry Rockx, Marion Koopmans, Xavier de Lamballerie, Thomas Jaenisch, ZIKAlliance Clinical Study Group, Thomas Jaenisch, Kerstin Daniela Rosenberger, Ivonne Morales, Frank Tobian, Lorenz Uhlmann, Moritz Pohl, Julius Schretzmann, Annika Leege, Ernesto T A Marques, Isabelle F T Viana, Roberto D Lins, Patrícia Brasil, Ana Maria Bispo de Filippis, Ana Claudia Machado Duarte, Otavio de Melo Espíndola, Myrna Bonaldo, Renata Rabello, Luana Damasceno, Vivian Avelino-Silva, Aluisio Segurado, Ester Sabino, Maria Cassia Mendes-Correa, Luis Nacul, Neal Alexander, Eduardo Martins Netto, Adriana Tami, Sarah Bethencourt, Cristel Falcon, Egri Rodríguez, Victmar Matos, Maria José Tinedo, Yenifer La Rosa, Marianela Murillo, Luis Angel Villar, Maria Consuelo Miranda, Anyela Lozano, Victor Mauricio Herrera, Adriana Gomez, Rosa Margarita Gelvez, Ricardo Ortiz, Carmen Soria, Lady Dimitrakis, Silvia Paola Salgado, Mary Regato Arrata, Eduardo Gotuzzo, Humberto Guerra Allison, Michael Talledo, Paola Mariela Saba Villarroel, Eric Martínez Torres, María G Guzmán, Pedro A Martínez Rodríguez, Mayling Alvarez Vera, Belkis Galindo Santana, Alicia Reyes, Silvia Serrano Álvarez, Diana Ferriol Dorticós, Jennifer Hegewisch-Taylor, Celia Alpuche-Aranda, Hugo López-Gatell, Esteban González-Diaz, Norma Pavía-Ruz, Victor Hugo Borja-Aburto, Cesar Gonzalez, Concepción Grajales, Teresita Rojas, Lumumba Arriaga, Alfonso Vallejos, Bruno Hoen, Dominique Tynevez, Xavier de Lamballerie, Laurence Thirion, Jan Felix Drexler, Barry Rockx, Eric van Gorp, Marion Koopmans

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.

Keywords: Arboviruses; Caribbean; Children; Cohort; Congenital abnormalities; Latin America; Mosquito-borne viruses; Natural history; Pregnant women; Risk; Vector-borne viruses; Zika.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
ZIKAlliance clinical cohorts: Pregnant Women (PW) cohort, Children (CH) cohort, and Natural History (NH) cohorts, including connected substudies and decentralized biobank
Fig. 2
Fig. 2
ZIKAlliance study sites for the pregnant women (PW), and children (CH) cohorts (map showing environmental suitability of Zika virus transmission according to Messina et al., 2016 [15], modified with inclusion of ZIKAlliance study sites)
Fig. 3
Fig. 3
ZIKV birth cohort comprising pregnant women (PW) and children (CH) cohort studies

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