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Zika Case Definition and Surveillance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03158233
Recruitment Status : Completed
First Posted : May 18, 2017
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:
This prospective, surveillance study will assess the operational Zika virus definition for use in future Zika purified inactivated virus (ZIKV) vaccine efficacy trials in order to identify Zika virus disease (ZVD) cases among the study cohort.

Condition or disease
Zika Virus Disease

Detailed Description:
This prospective, multicenter, cohort study will conduct active and passive surveillance for ZVD and determine its prevalence and seroconversion incidence in areas of Latin America experiencing Zika epidemic activity. A description of the occurrence of dengue virus and chikungunya virus infections in the cohort may also be provided as differential diagnosis of ZVD.
Study Design
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Study Type : Observational
Actual Enrollment : 2400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Surveillance and Case Definition Study of Zika Virus Disease and Infection in Adolescents and Adults in Latin America in Preparation for an Efficacy Trial of a Zika Virus Whole Virion, Purified Inactivated Vaccine
Actual Study Start Date : April 29, 2017
Actual Primary Completion Date : December 19, 2018
Actual Study Completion Date : December 19, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with suspected ZVD and virologically confirmed Zika (VCZ) infection in the cohort [ Time Frame: Day 0 to Day 365 ]
    Number of suspected ZVD and VCZ infections

  2. Summary of the signs and symptoms accompanying suspected ZVD and VCZ cases in the study participants [ Time Frame: Day 0 to Day 365 ]
    Occurrence, intensity, and duration of signs and symptoms of ZVD and VCZ cases


Biospecimen Retention:   Samples Without DNA
Blood samples and urine samples

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Prospective, multi-center, cohort study in 2400 subjects aged 15 to 40 years at enrollment in 4 countries in Latin America: Colombia, Honduras, Mexico, and Puerto Rico
Criteria

Inclusion Criteria:

  1. Aged 15 to 40 years on the day of inclusion, currently residing in the site zone, and planning to continue to reside in the site zone for the duration of the study
  2. For subjects under the age of majority on the day of inclusion: the assent form has been signed and dated by the subject (if required by local regulations), and the informed consent form has been signed and dated by the parent(s) or legal guardian(s).

For subjects at or over the age of majority on the day of inclusion: the informed consent form has been signed and dated.

3) Subject (and parent/guardian if subject is under the age of majority) able to attend all scheduled visits and to comply with all study procedures 4) In good health, based on medical history and physical examination Exclusion Criteria:

  1. Subject is pregnant (as self-reported)
  2. Participation in the 4 weeks preceding enrollment, or planned participation during the present study period, in a clinical trial investigating a vaccine, drug, medical device, or a medical procedure
  3. Receipt of any dengue or yellow fever vaccine in the 4 weeks preceding the day of enrollment or planned receipt of any dengue or yellow fever vaccine during the study period
  4. Receipt of immune globulins, blood or blood-derived products in the past 3 months
  5. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  6. History of Zika virus disease, confirmed either clinically, serologically, or virologically
  7. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
  8. Current alcohol abuse or drug addiction
  9. Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily
  10. Identified as an investigator or an employee of the investigator or study center, with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158233


Locations
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Colombia
Investigational Site
Floridablanca, Santander, Colombia
Investigational Site
Cali, Valle Del Cauca, Colombia
Honduras
Investigational site
Tegucigalpa, Honduras, 11101
Mexico
Investigational Site
Acapulco, Guerrero, Mexico, 39670
Investigational Site
Temixco, Morelos, Mexico, 62587
Puerto Rico
Investigational Site
Carolina, Puerto Rico, 984
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
More Information
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Additional Information:

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT03158233    
Other Study ID Numbers: VAG00001
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Zika virus disease
Additional relevant MeSH terms:
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Virus Diseases
Zika Virus Infection
Infections
Arbovirus Infections
 Vector Borne Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections