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

Completed · Phase 1 · Has a placebo group

Conditions studied: Virus, Zika, Zika Virus Disease, Flavivirus Infections, Healthy Participants

In brief

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.

Key facts

Study ID

NCT03343626

Run by

Takeda

People needed

271

Starts

2017-11-13

Expected to finish

2020-11-24

Last updated by the study team

2022-02-11

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and eligibility screening tests (hematology, biochemistry and urinalysis) and clinical judgment of the investigator. Vital signs must be within normal limits (ie, below Grade 1 as specified in the Food and Drug Administration [FDA] Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers). Screening tests must be within normal limits or not be above Grade 1 as defined in the FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers.
• Participants who can comply with trial procedures and are available for the duration of follow-up.
• All female participants must be willing to undergo serum beta human chorionic gonadotropin (B-hCG) pregnancy test and must test negative by urine pregnancy test prior to each study vaccination.

You may not qualify if…

• Participants and participants' partners with confirmed Zika virus (ZIKV) infection by self-report.
• Traveling to flavivirus endemic countries or flavivirus endemic regions of the United States (US) or US territories*, within 4 weeks prior to screening or planned travel through to Visit 6 (applicable only to participants to be enrolled into the flavivirus naïve cohort).
• a. Centers for Disease Control and Prevention (CDC) website define the information about the flavivirus endemic countries and US regions and territories.
• Known hypersensitivity or allergy to any of the vaccine candidate components (including excipients of the investigational vaccine or placebo).
• Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (example, Guillain-Barré syndrome).
• Known or suspected impairment/alteration of immune function, including:
• Chronic use of oral steroids (equivalent to 20 milligram per day [mg/day] prednisone greater than or equal to [>=] 12 weeks / >= 2 milligram per kilogram [mg/kg] body weight / day prednisone >= 2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
• Receipt of parenteral steroids (equivalent to 20 mg/day prednisone >= 12 weeks / >= 2 mg/kg body weight / day prednisone >= 2 weeks) within 60 days prior to Day 1.
• Receipt of immunostimulants within 60 days prior to Day 1.
• Receipt of parenteral, epidural or intra-articular immunoglobulin preparation, blood products, and/or plasma derived products within 3 months prior to Day 1 or planned during the full length of the trial. In addition, participants must be advised not to donate blood during the study period.
• Known Human Immunodeficiency Virus (HIV) infection or HIV-related disease.
• Genetic immunodeficiency.
• Has known current or chronic hepatitis B and/or hepatitis C infections.
• Has abnormalities of spleen or thymic function.
• Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
• Individuals participating in any clinical trial with another investigational product, including ZIKV vaccine clinical trial within 30 days prior to first trial visit or intent to participate in another clinical trial at any time during the conduct of this trial.
• Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of investigational vaccine/placebo administration.
• Female participants who are pregnant or breastfeeding, or are planning to become pregnant.
• Any positive or indeterminate pregnancy test.
• If female participant of childbearing potential, sexually active, and who has not used any of the "acceptable contraceptive methods" for at least 2 months prior to trial entry:
• "Of childbearing potential" is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years without any other alternative medical cause (as confirmed by a healthcare professional), status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
• Acceptable birth control methods are defined as one or more of the following:
• Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring).
• Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse.
• Intrauterine device.

Where it is running

• Clinical Research of South Florida — Coral Gables, Florida, United States
• Miami Research Associates — Miami, Florida, United States
• AppleMed Research — Miami, Florida, United States
• Johnson County Clin-Trials — Lenexa, Kansas, United States
• Regional Clinical Research Inc. — Endwell, New York, United States
• Rochester Clinical Research — Rochester, New York, United States
• Tekton Research — Austin, Texas, United States
• Puerto Rico Clinical and Translational Research Consortium — San Juan, PR, Puerto Rico
• Ponce Medical School Foundation — Santurce, PR, Puerto Rico

Full record on ClinicalTrials.gov

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