Zika Virus Strains for Zika Virus

Recruiting in Palo Alto (17 mi)

Overseen byAnna Durbin, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Trial Summary

What is the purpose of this trial?

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.

Research Team

Anna Durbin, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

I am willing to use effective birth control due to Zika risk.

I am willing to stay in the hospital for at least 9 days after getting the ZIKV vaccine or a placebo.

Available for the duration of the study, approximately 26 weeks post-inoculation

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Exclusion Criteria

Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol

My blood tests for immune cells, liver function, and kidney health are within normal limits.

Any significant alcohol or drug abuse in the past 12 months which has caused medical, occupational, or family problems, as indicated by subject history

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Treatment Details

Interventions

Experimental: ZIKV-Nicaragua/2016 Strain (Virus Therapy)
Placebo (Other)
ZIKV-SJRP/2016-184 Strain (Virus Therapy)

Trial OverviewThe 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.

Participant Groups

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