Zika Case Definition and Surveillance Study

Completed

• Conditions: Zika Virus Disease

• Registration Number: NCT03158233
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

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 Timeline

• Study Start: 2017-04-29
• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-18
• Primary Completion: 2018-12-19
• Study Completion: 2018-12-19
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with suspected ZVD and virologically confirmed Zika (VCZ) infection in the cohort	Day 0 to Day 365	Number of suspected ZVD and VCZ infections
Summary of the signs and symptoms accompanying suspected ZVD and VCZ cases in the study participants	Day 0 to Day 365	Occurrence, intensity, and duration of signs and symptoms of ZVD and VCZ cases

Trial Locations

Locations (2)

Investigational site; 🇭🇳 Tegucigalpa, Honduras

Investigational Site; 🇵🇷 Carolina, Puerto Rico