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Virus Therapy
Zika Virus Strains for Zika Virus
Phase 1
Recruiting
Led By Anna Durbin, MD
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult ZIKV and DENV-naïve male and non-pregnant females 18 - 40 years of age, inclusive
Volunteers on hormonal birth control must not be on medications or other agents that decrease the effectiveness of hormonal birth control
Must not have
History of seizure disease or peripheral neuropathy
Any known immunodeficiency syndrome, including that caused by malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up thru 180 days post-administration of the zikv strain
Awards & highlights
Summary
This trial involves injecting healthy adults with a small dose of the Zika virus to study their immune response. The goal is to find the best virus strain and dose for future vaccine development. Participants are healthy adults who have never been exposed to Zika or Dengue viruses.
Who is the study for?
This trial is for healthy men and women aged 18-40 who have never had Zika or Dengue virus, are not pregnant, and agree to use contraception. Women on hormonal birth control must avoid medications that reduce its effectiveness. Participants must be in good health, able to stay in the hospital for up to 16 days post-inoculation, and follow CDC guidelines for contraception.
What is being tested?
The study tests two strains of the Zika virus (ZIKV-SJRP/2016-184 and ZIKV-Nicaragua/2016) against a placebo in four groups of volunteers. Each group receives different doses with ten subjects getting the virus strain and four receiving a placebo. The aim is to evaluate these strains' suitability for future research.
What are the potential side effects?
Potential side effects may include typical responses to viral infections such as fever, rash, joint pain, muscle pain, headaches or conjunctivitis (red eyes). There's also a risk of more serious complications like Guillain-Barré syndrome but this will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 40 years old and have never had Zika or Dengue fever.
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I am not taking anything that reduces my birth control's effectiveness.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of seizures or nerve damage.
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I have an immune system disorder caused by a disease.
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I have been diagnosed with HIV.
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I have received a Zika or Dengue vaccine before.
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I have had a condition that caused inflammation in my nervous system, like Bell's Palsy.
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I have had Guillain-Barré syndrome in the past.
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I do not have a spleen.
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I haven't received a live vaccine in the last 21 days or a killed vaccine in the last 14 days.
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I haven't taken steroids or immunosuppressants in the last 28 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ thru 180 days post-administration of the zikv strain
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~thru 180 days post-administration of the zikv strain
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The frequency, magnitude, and duration of ZIKV presence in the blood, urine, cervico-vaginal secretions, semen, and saliva
The infection frequency of ZIKV by strain and by dose
Secondary study objectives
Characterize the clinical presentation of acute ZIKV infection by assessing the frequency of adverse events (AEs) Adverse Events
Determine the quantity and duration of ZIKV presence shedding in cervico-vaginal secretions
Determine the quantity and duration of ZIKV presence shedding in urine
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: ZIKV-SJRP/2016-184 StrainExperimental Treatment1 Intervention
Dose of 10ˆ2 PFU
Group II: ZIKV-Nicaragua/2016 StrainExperimental Treatment1 Intervention
Dose of 10ˆ2 PFU
Group III: PlaceboPlacebo Group1 Intervention
PlasmaLyte
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Zika Virus primarily focus on symptom management and supporting the immune response. Antiviral medications, although not specifically approved for Zika, work by inhibiting the virus's ability to replicate.
Immune-based therapies, such as monoclonal antibodies, directly target and neutralize the virus. These mechanisms are important for Zika Virus patients as they help in reducing the viral load, potentially leading to better clinical outcomes and faster recovery.
[West Nile virus. II. Immunopathophysiology in humans].
[West Nile virus. II. Immunopathophysiology in humans].
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,311 Previous Clinical Trials
5,626,640 Total Patients Enrolled
4 Trials studying Zika Virus
3,139 Patients Enrolled for Zika Virus
Anna Durbin, MDPrincipal InvestigatorJohns Hopkins University
30 Previous Clinical Trials
1,441 Total Patients Enrolled
1 Trials studying Zika Virus
56 Patients Enrolled for Zika Virus
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