Trials / Completed
CompletedNCT03356561
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers
A Randomized, Double-blind, Placebo-controlled, First-in-Human Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Janssen Vaccines & Prevention B.V. · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of Ad26.ZIKV.001 at 2 dose levels, 5\*10\^10 viral particles (vp) and 1\*10\^11 vp, administered intramuscularly as single dose and as 2-dose schedules in healthy adults.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ad26.ZIKV.001 5*10^10 vp | Participants will receive Ad26.ZIKV.001 at a dose of 5\*10\^10 vp via IM route. |
| BIOLOGICAL | Ad26.ZIKV.001 1*10^11 vp | Participants will receive Ad26.ZIKV.001 at a dose of 1\*10\^11 vp via IM route. |
| BIOLOGICAL | Placebo | Participants will receive placebo via IM route. |
Timeline
- Start date
- 2017-11-26
- Primary completion
- 2019-09-23
- Completion
- 2019-09-23
- First posted
- 2017-11-29
- Last updated
- 2019-10-15
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03356561. Inclusion in this directory is not an endorsement.