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A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers

NCT03356561 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-10-15

No results posted yet for this study

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

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Janssen Vaccines & Prevention B.V.

    lead INDUSTRY

Principal Investigators

  • Janssen Vaccines & Prevention B.V. Clinical Trial · Janssen Vaccines & Prevention B.V.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-26
Primary Completion
2019-09-23
Completion
2019-09-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03356561 on ClinicalTrials.gov