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Virus Therapy

Zika Virus Strains for Zika Virus

Q: What are the prerequisites for joining this experiment?

<p>70 adult, <a href="https://www.withpower.com/clinical-trials/zika-virus">zika virus</a>-naive individuals aged 18 to 40 are being recruited for this clinical trial. Participants must possess sterling health and be capable of committing the entire 26 weeks post inoculation; reside in an inpatient unit for 16 days (or longer if needed); employ barrier contraception during intercourse through day 56; women of childbearing potential needing to utilize reliable <a href="https://www.withpower.com/clinical-trials/birth-control">birth control</a> methods or same sex couples not intending on conceiving a baby exempted from such measures. Hormonal contraceptive users additionally obligated to abstain from medications that diminish its effectiveness.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up thru 180 days post-administration of the zikv strain

Awards & highlights

Study Summary

This trial will study the effects of the Zika virus on 70 female subjects. 10 subjects in each of 5 cohorts will be given the virus, while the remaining 4 in each cohort will act as a control and receive a placebo.

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.Check my eligibility

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.See study design

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

Select...

I am between 18 and 40 years old and have never had Zika or Dengue fever.

Select...

I am not taking anything that reduces my birth control's effectiveness.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The frequency and severity of clinical signs and symptoms of infection

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 outcome measures

Characterize the clinical presentation of acute ZIKV infection by assessing the frequency of adverse events (AEs) Adverse Events

Determine the peak neutralizing antibody response to ZIKV

Determine the quantity and duration of ZIKV presence shedding in cervico-vaginal secretions

+5 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 / 2Eligibility criteria met

Find a Location

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

3,269 Previous Clinical Trials

5,481,431 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA approved the ZIKV-Nicaragua/2016 Strain for use?

"As this is an initial Phase 1 trial, and there are few data points to draw from, our team puts the safety of Experimental: ZIKV-Nicaragua/2016 Strain at a score of 1."

Answered by AI

Are there any vacancies remaining in this research project?

"Affirmative. Clinicaltrials.gov has documented that this clinical trial, which initiated on February 16th 2022, is currently enrolling individuals for participation. 70 participants need to be signed up from one location."

Answered by AI

How many subjects are receiving treatments as part of this research program?

"Affirmative. Clinicaltrials.gov reveals that this medical experiment is actively enrolling volunteers, beginning on February 16th 2022 and most recently revised on September 26th 2022. 70 participants are being sought from a single trial location."

Answered by AI

What are the prerequisites for joining this experiment?

"70 adult, zika virus-naive individuals aged 18 to 40 are being recruited for this clinical trial. Participants must possess sterling health and be capable of committing the entire 26 weeks post inoculation; reside in an inpatient unit for 16 days (or longer if needed); employ barrier contraception during intercourse through day 56; women of childbearing potential needing to utilize reliable birth control methods or same sex couples not intending on conceiving a baby exempted from such measures. Hormonal contraceptive users additionally obligated to abstain from medications that diminish its effectiveness."

Answered by AI

Is the eligibility criteria for this study restricted to individuals aged 20 or above?

"The age range for participants in this clinical trial is between 18 to 40. For those younger or older than that, there are separate trials accommodating minors and seniors respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Two Zika Viruses for Use in Controlled Human Infection Models (CHIM)

2022. "Evaluation of Two Zika Viruses for Use in Controlled Human Infection Models (CHIM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05123222.

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