Experimental: ZIKV-Nicaragua/2016 Strain for Zika Virus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Zika Virus+1 More
Experimental: ZIKV-Nicaragua/2016 Strain - Other
Eligibility
18 - 65
Female
What conditions do you have?
Select

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.

Eligible Conditions
  • Zika Virus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 6 Secondary · Reporting Duration: Thru 90 days post-administration of the ZIKV strain

Day 28
Characterize the clinical presentation of acute ZIKV infection by assessing the frequency of adverse events (AEs) Adverse Events
Day 90
Determine the peak neutralizing antibody response to ZIKV
Determine the quantity and duration of ZIKV presence shedding in urine
Determine the quantity and duration of ZIKV presence shedding saliva
Zika Virus
Find a suitable ZIKV CHIM Strain
Magnitude of serum neutralizing antibody response in patients who received administration of ZIKV infection.
The frequency, magnitude, and duration of ZIKV presence in the blood, urine, cervico-vaginal secretions, and saliva
The infection frequency of ZIKV by strain and by dose
Day 90
Response rate of both ZIKV Strains for use in a safety-assured Zika CHIM
The frequency and severity of clinical signs and symptoms of infection

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

ZIKV-Nicaragua/2016 Strain
1 of 3
ZIKV-SJRP/2016-184 Strain
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

70 Total Participants · 3 Treatment Groups

Primary Treatment: Experimental: ZIKV-Nicaragua/2016 Strain · Has Placebo Group · Phase 1

ZIKV-Nicaragua/2016 Strain
Other
Experimental Group · 1 Intervention: Experimental: ZIKV-Nicaragua/2016 Strain · Intervention Types: Other
ZIKV-SJRP/2016-184 Strain
Other
Experimental Group · 1 Intervention: ZIKV-SJRP/2016-184 Strain · Intervention Types: Other
Placebo
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Biological

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: thru 90 days post-administration of the zikv strain

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,127 Previous Clinical Trials
5,060,901 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

Eligibility Criteria

Age 18 - 65 · Female Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a female 18 to 40 years of age, inclusive.
You have good general health as determined by physical examination, laboratory screening, and review of medical history.
You are available for the duration of the study.
You must be able to complete the informed consent process and comprehension assessment independently and without assistance.
You are willing to participate in the study.
You are willing to use barrier contraception during cervico-vaginal, anal, and oral intercourse through study day 56.
Volunteers on hormonal birth control must not be on medications or other agents that decrease the effectiveness of hormonal birth control.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: October 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.