A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: Dengue Fever

In brief

The study is designed to afford a safety and immunogenicity assessment of three Tetravalent Dengue Virus-Purified Inactivated Vaccine(TDENV-PIV) vaccine candidates.

Key facts

Study ID: NCT01666652
Run by: U.S. Army Medical Research and Development Command
People needed: 100
Starts: 2012-09-01
Expected to finish: 2017-11-01
Last updated by the study team: 2019-01-25

Who can join

Age: 18 and older, up to 39. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, etc.)
A male or female between 18 and 39 years of age (inclusive) at the time of consent
Written informed consent obtained from the subject
Healthy subjects as established by medical history and clinical examination before entering into the study
Female subjects of non-childbearing potential (non-childbearing potential is defined as having either a current tubal ligation at least three months prior to enrollment, hysterectomy, ovariectomy, or is post-menopause). See Definition of Terms for adequate contraception.
Female subjects of childbearing potential may be enrolled in the study, if the subject has:
Practiced adequate contraception for 30 days prior to vaccination, and
A negative urine pregnancy test on the day of vaccination, and
Agreed to continue adequate contraception until two months after completion of the vaccination series

You may not qualify if…

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines/placebo during the period starting 30 days preceding the first dose of study vaccine/placebo and/or planned use during the study period
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to the first vaccine/placebo dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent; inhaled and topical steroids are allowed)
Planned administration or administration of a vaccine/product not foreseen by the study protocol during the period starting 30 days prior to the first dose of vaccine/placebo until after the visit at Day 56 (if influenza activity warrants vaccination of healthy young adults, influenza vaccination will be encouraged and will not lead to study exclusion)
Planned administration of any flavivirus vaccine for the entire study duration
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Family history of congenital or hereditary immunodeficiency
History of, or current auto-immune disease
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/placebo or related to a study procedure
Major congenital defects or serious chronic illness
History of any neurological disorders or seizures
Acute disease and/or fever (≥37.5°C/99.5°F oral body temperature) at the time of enrollment (a subject with a minor illness, i.e., mild diarrhea, mild upper respiratory infection, etc., without fever, may be enrolled at the discretion of the investigator)
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality,as determined by physical examination or laboratory screening tests
Administration of immunoglobulins and/or any blood products during the period starting 90 days preceding the first dose of study vaccine/placebo or planned administration during the study period
History of chronic alcohol consumption and/or drug abuse
Pregnant or lactating female or female planning to become pregnant or planning to discontinue contraceptive precautions
A planned move to a location that will prohibit participating in the trial until study end for the participant
Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Subject seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV)
Safety laboratory test results that are outside the acceptable values at screening. The following values are not acceptable:
>110% upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, creatinine, serum urea nitrogen (SUN) and bilirubin (total and direct)
<100% lower limit of normal (LLN) or > 120% ULN for hemoglobin, hematocrit and platelet count
<75% LLN or >110% ULN for total white blood cell count (WBC) Note that all screening laboratory results must be either within normal limits (WNL) or no more than Grade l not clinically significant (NCS)
(LLN=lower limit of normal; ULN= upper limit of normal, WNL= within normal limits, NCS= not clinically significant)

Where it is running

WRAIR, Clinical Trials Center — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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