NCT03611946

Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults

Phase I Evaluation of the Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1 double-blind, placebo controlled trial designed to evaluate the safety, reactogenicity, and immunogenicity of a single dose of the live attenuated Zika vaccine rZIKV/D4Δ30-713 in adults with no history of previous flavivirus infection.

Detailed description

Fifty-six healthy volunteers will be enrolled over 2 sequential cohorts: Cohort 1: n=28, volunteers will be randomly assigned to a single dose of either vaccine (10\^3 PFU, n=20) or placebo (n=8). Cohort 1 will be enrolled and evaluated first. If the vaccine is not found to induce seroconversion to ZIKV in \> 80% of subjects inoculated with 10-\^3 PFU of the vaccine, a second cohort of volunteers will be enrolled and will be inoculated with 10\^4 PFU of vaccine (or placebo). Cohort 2: n=28, volunteers will be randomly assigned to a single dose of either vaccine (10\^4 PFU, n=20) or placebo (n=8). All volunteers will be followed on an outpatient basis for 6 months following vaccination (13 follow up visits over 180 days). Follow up visits will include clinical assessments as well as sample collection for evaluation of viremia and seroconversion. Sample collection will include blood, urine, saliva, nasopharyngeal or midturbinate swab, vaginal secretion or semen collection on specified visit days throughout the 180 day follow up period.

Conditions

• Zika Virus

Interventions

Type	Name	Description
BIOLOGICAL	Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml)	Administered at a dose of 10\^3 plaque-forming units (PFUs) by subcutaneous injection
BIOLOGICAL	Single dose of placebo via subcutaneous injection (0.5ml).	Administered by subcutaneous injection.
BIOLOGICAL	Single dose of rZIKV/D4Δ30-713 (10^4 PFU) via subcutaneous injection (0.5ml)	Administered at a dose of using 10\^4 plaque-forming units (PFUs) by subcutaneous injection.

Timeline

• Start date: 2018-07-06
• Primary completion: 2022-03-18
• Completion: 2022-03-18
• First posted: 2018-08-02
• Last updated: 2025-08-05
• Results posted: 2025-08-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study