Zika Case Definition and Surveillance Study

• ClinicalTrials.gov Identifier: NCT03158233
• Recruitment Status: Completed
• First Posted: May 18, 2017
• Last Update Posted: May 24, 2019
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

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

• 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

Groups and Cohorts

Outcome Measures

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

• 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

Locations

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

Additional Information:

Related Info 

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT03158233
• Other Study ID Numbers: VAG00001
• First Posted: May 18, 2017
• Last Update Posted: May 24, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• 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:

Zika Virus Infection; Virus Diseases; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections