Clinical trial NCT03158233: Zika Case Definition and Surveillance Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Zika Virus Disease
Keywords: Zika virus disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2017-05-18
Enrollment: 2400
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility 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.

Primary outcomes:
measure: Number of participants with suspected ZVD and virologically confirmed Zika (VCZ) infection in the cohort
timeFrame: Day 0 to Day 365
measure: Summary of the signs and symptoms accompanying suspected ZVD and VCZ cases in the study participants
timeFrame: Day 0 to Day 365
Secondary outcomes:
Other outcomes:
Locations:
city: Floridablanca
country: Colombia
facility: Investigational Site
state: Santander
city: Cali
country: Colombia
facility: Investigational Site
state: Valle Del Cauca
city: Tegucigalpa
country: Honduras
facility: Investigational site
city: Acapulco
country: Mexico
facility: Investigational Site
state: Guerrero
city: Temixco
country: Mexico
facility: Investigational Site
state: Morelos
city: Carolina
country: Puerto Rico
facility: Investigational Site
Study officials:
References: