Zika Virus Strains for Zika Virus

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.

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

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

Exclusion Criteria

I have a history of seizures or nerve damage.

I have an immune system disorder caused by a disease.

I have been diagnosed with HIV.

I have received a Zika or Dengue vaccine before.

I have had a condition that caused inflammation in my nervous system, like Bell's Palsy.

I have had Guillain-Barré syndrome in the past.

I do not have a spleen.

I haven't received a live vaccine in the last 21 days or a killed vaccine in the last 14 days.

I haven't taken steroids or immunosuppressants in the last 28 days.

Treatment Details

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.

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