Zika Virus and Related Arbovirus Infections in Deferred Blood Donors (ZVADD)

NCT02794181 | Completed

• 2 other identifiers: 16012416-CC-0124
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Zika virus is mostly passed on by the bite of an infected mosquito. It usually causes mild illness. But in pregnant women it can cause serious birth defects to the baby. The virus can also spread by blood transfusion and sexual intercourse. This is why the U.S. Food \& Drug Administration (FDA) recommended that people should not give blood if possibly exposed to Zika virus. Dengue virus and chikungunya virus are passed by the same mosquitoes as Zika virus. These can cause severe reactions if passed through transfused blood. Donated blood is usually not tested for these three viruses. Researchers want to count the infections in people who have been exposed because of travel or sexual exposure. They want to learn the risk these viruses might pose to the U.S. blood supply. They also want to study the natural history of these viruses by following infected people over time. Objective: To study the risk of Zika, dengue, and chikungunya viruses to the U.S. blood supply. Eligibility: Adults age 18 or older who were turned down for donating blood because of possible exposure to certain viruses. Design: Participants will have blood and urine tests. They will answer questions about their travel. They will be called in about a week with virus test results. Participants with negative results do not have any more study visits. Participants with positive results will be asked to stay in the study for 6 months. They will have weekly clinic visits and tests until results are negative for 2 straight weeks. Once test results are negative, they will have monthly visits. Visits will include physical exams, blood and urine samples, and optional semen samples from men. Most people will have 3-4 weekly visits and 5 monthly visits.

Conditions

Zika Virus; Dengue Virus; Chikungunya Virus Infections

Keywords

Transfusion-Transmitted Infections; Dengue Virus; Chikungunya Virus; Natural History; Blood Transfusion

Outcome Measures

Primary Outcomes (3)

• Prevalence of ZIKV, DENV and CHIKV infection (RNA-positives) among travel-deferred adult blood donors in the study population.

  Time 0; among RNA-positives: weeks 1,2,3,4,5,6,7,8,9,10,11,12,16,20,24

• Prevalence of ZIKV infection (RNApositives) among adult blood donors with a history of potential sexual exposure to ZIKV infection, in the study population.

  Time 0; among RNA-positives: weeks 1,2,3,4,5,6,7,8,9,10,11,12,16,20,24

• 24-week Natural History of ZIKV, DENV and CHIKV (RNA-positives).

  weeks 1,2,3,4,5,6,7,8,9,10,11,12,16,20,24

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults who traveled within the past month to places with local transmission of ZIKV, DENV and/or CHIKV who would otherwise be eligible to donate blood;
• Volunteer adult blood donors or potential blood donors who are deferred from blood donation because they tested positive for Zika virus.
• Volunteer adult blood and platelet donors (blood donors) who present to the NIH Clinical Center Department of Transfusion Medicine (DTM) and the Fishers Lane Donor Center are eligible for study enrollment if they:
• Are deferred because of travel to an area with active ZIKV transmission within the past 4 weeks; or
• Are deferred because of sexual contact during the past 4 weeks with a sexual partner who traveled to an area with active ZIKV transmission in the 3 months prior to that instance of sexual contact; or
• Are deferred because of travel to a malaria-endemic area; and returned from the area in the past month; or
• Have donated blood or platelets AND within 2 weeks of donation they called the NIH DTM or Fishers Lane Donor Centers to report any signs or symptoms of infection, AND they traveled to an area with active transmission of ZIKV, DENV or CHIKV within the past 4 weeks (from symptom onset); OR had sexual contact within the past 4 weeks (from symptom onset) with a sexual partner who traveled to an area with active ZIKV transmission in the 3 months prior to that instance of sexual contact.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Musso D, Nhan T, Robin E, Roche C, Bierlaire D, Zisou K, Shan Yan A, Cao-Lormeau VM, Broult J. Potential for Zika virus transmission through blood transfusion demonstrated during an outbreak in French Polynesia, November 2013 to February 2014. Euro Surveill. 2014 Apr 10;19(14):20761. doi: 10.2807/1560-7917.es2014.19.14.20761.

  PMID: 24739982 BACKGROUND

• Alter HJ, Stramer SL, Dodd RY. Emerging infectious diseases that threaten the blood supply. Semin Hematol. 2007 Jan;44(1):32-41. doi: 10.1053/j.seminhematol.2006.09.016.

  PMID: 17198845 BACKGROUND

• Lanciotti RS, Kosoy OL, Laven JJ, Velez JO, Lambert AJ, Johnson AJ, Stanfield SM, Duffy MR. Genetic and serologic properties of Zika virus associated with an epidemic, Yap State, Micronesia, 2007. Emerg Infect Dis. 2008 Aug;14(8):1232-9. doi: 10.3201/eid1408.080287.

  PMID: 18680646 BACKGROUND

MeSH Terms

Conditions

Zika Virus Infection; Chikungunya Fever; Transfusion Reaction

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Alphavirus Infections; Togaviridae Infections; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Officials

• Robert D Allison, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 9, 2016
• Study Start: June 8, 2016
• Primary Completion: March 14, 2019
• Study Completion: March 14, 2019
• Last Updated: March 18, 2019

Record last verified: 2019-03-14

Locations

US (1)