Zika Virus Clinical Trial
Official title:
Study of Zika Virus and Related Arbovirus Infections in Deferred Blood Donors
Verified date | March 14, 2019 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | March 14, 2019 |
Est. primary completion date | March 14, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
- INCLUSION CRITERIA: - 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: 1. Are deferred because of travel to an area with active ZIKV transmission within the past 4 weeks; or 2. 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 3. Are deferred because of travel to a malaria-endemic area; and returned from the area in the past month; or 4. 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. EXCLUSION CRITERIA: Potential donors who do not meet the inclusion criteria are excluded. Potential donors under 18 years of age, paid or research blood donors and pregnant women are excluded from enrollment. Children are not eligible to donate blood without parental consent and the frequency of number of follow-up visits places an undue burden on school age children. Paid or research blood donors are not representative of the normal blood donor population. Pregnant women are not eligible to donate blood. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) |
United States,
Alter HJ, Stramer SL, Dodd RY. Emerging infectious diseases that threaten the blood supply. Semin Hematol. 2007 Jan;44(1):32-41. Review. — View Citation
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. — View Citation
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). pii: 20761. Erratum in: Euro Surveill. 2014;19(15):pii/20771. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Primary | 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 | ||
Primary | 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 |
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