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Randomized, Placebo-controlled, Observer-blinded Phase 1 Safety and Immunogenicity Study of Inactivated Zika Virus Vaccine Candidate in Healthy Adults

NCT03425149 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2019-07-05

No results posted yet for this study

Summary

In this Phase 1 study, two target dose levels of VLA1601, a purified, inactivated, whole Zika virus (ZIKV) vaccine candidate adsorbed on aluminum hydroxide (alum) will be evaluated: 6 antigen units (AU) and 3 AU of inactivated ZIKV vaccine. Each dose will be administered intramuscularly (i.m.) in the deltoid muscle on Days 0 and 28. In addition, an accelerated 2-dose vaccination schedule on Days 0 and 7 will be assessed for both doses.

Conditions

  • Zika Virus
  • Zika Virus Infection

Interventions

BIOLOGICAL

VLA1601

purified inactivated ZIKV vaccine candidate adsorbed on alum

BIOLOGICAL

Placebo

Phosphate buffered saline (PBS)

Sponsors & Collaborators

  • Emergent BioSolutions

    collaborator INDUSTRY

  • Valneva Austria GmbH

    lead INDUSTRY

Principal Investigators

  • Katrin Dubischar · Valneva Austria GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-02-24
Primary Completion
2018-06-26
Completion
2018-11-16
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 NCT03425149 on ClinicalTrials.gov