What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for viral infections like Zika Virus often include supportive care and antiviral medications. Known side effects of antiviral treatments can include gastrointestinal symptoms (nausea, vomiting, diarrhea), headache, dizziness, and fatigue. In some cases, more severe side effects such as liver toxicity, allergic reactions, or hematologic abnormalities may occur. It is important to consult with a healthcare provider for specific treatment recommendations and potential side effects.

What prior FDA approvals exist?

There are no FDA-approved drugs specifically for the treatment of Zika Virus. The trial mentioned involves the administration of ZIKV to study immune responses, but it does not reference any approved treatments. Therefore, no specific drugs or biologics have been approved by the FDA for Zika Virus treatment.

What other types of research exist?

Promising novel alternatives for Zika Virus treatment in 2024 may include advancements in vaccine development and antiviral therapies. Controlled Human Infection Models (CHIM) are being used to evaluate the efficacy of new Zika Virus vaccines. Additionally, research into monoclonal antibodies and other antiviral agents could provide effective treatment options. Patients should consult with their healthcare providers to discuss the latest available treatments and participate in clinical trials if eligible.

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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

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and thru 180 days post-administration of the zikv strain for reporting.

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 more

Trial 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

0 / 11Eligibility criteria met

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].