NCT03343626

Safety, Immunogenicity, and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Participants

A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Safety, Immunogenicity, and Dose Ranging Study of Purified Inactivated Zika Virus Vaccine (PIZV) Candidate in Flavivirus Naïve and Primed Healthy Adults Aged 18 to 49 Years

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to describe the safety, tolerability and immunogenicity of two doses of purified inactivated Zika virus vaccine (PIZV) given 28 days apart. Three different vaccine doses containing different protein concentrations (2, 5 or 10 microgram \[mcg\]) each, will be given as 2 dose schedule to flavivirus naive and primed healthy adults. Participants will be followed for 7 days post each dose for tolerability and up to 6 months post dose 2 for safety. Immunogenicity assessment will be performed at 28 days post each dose and 6 months post dose 2. In addition, the selected dose group and control group will be followed till 24 months post dose 2 for safety and persistence of immunity.

Detailed description

The vaccine being tested in this study is called PIZV or TAK-426 adjuvanted with aluminum hydroxide. The Zika virus vaccine is being tested to provide safety and immunogenicity data to enable the vaccine to be further developed clinically. The study will enroll approximately 240 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four groups-which will remain undisclosed to the study observer: * Placebo * PIZV: 2 microgram (mcg) Low Dose * PIZV: 5 mcg Medium Dose * PIZV: 10 mcg High Dose All participants will be administered either placebo or PIZV by intramuscular (IM) injection into the middle third of the deltoid muscle, preferably in the non-dominant arm on Days 1 (Visit 1) and 29 (Visit 4). This multi-center trial will be conducted in the United States and Puerto Rico. The overall time to participate in this study is up to 25 months. Participants will make multiple visits to the clinic on Days 1, 8, 29, 36, 57, 211, 393 and will be contacted by telephone on Day 133 (Visit 7) and Day 575 (Visit 9) and also visit the clinic on Day 757 (Visit 11) depending on the study arm, for a final follow-up assessment.

Conditions

• Virus, Zika
• Zika Virus Disease
• Flavivirus Infections
• Healthy Participants

Interventions

Type	Name	Description
DRUG	Placebo	Placebo (normal saline (0.9% NaCl) IM injection.
BIOLOGICAL	PIZV	Purified inactivated Zika virus vaccine with aluminum hydroxide adjuvant IM injection.

Timeline

• Start date: 2017-11-13
• Primary completion: 2018-12-28
• Completion: 2020-11-24
• First posted: 2017-11-17
• Last updated: 2022-02-11
• Results posted: 2022-02-11

Locations

9 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study