NCT03425149

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

A Randomized, Placebo-controlled, Observer-blinded Phase 1 Study to Assess the Safety and Immunogenicity of Two Different Dose Levels of an Alum Adjuvanted Inactivated Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Flavivirus-naïve Adults Aged 18 to 49 Years

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Valneva Austria GmbH · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
BIOLOGICAL	VLA1601	purified inactivated ZIKV vaccine candidate adsorbed on alum
BIOLOGICAL	Placebo	Phosphate buffered saline (PBS)

Timeline

• Start date: 2018-02-24
• Primary completion: 2018-06-26
• Completion: 2018-11-16
• First posted: 2018-02-07
• Last updated: 2019-07-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study