A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults (DPIV-001)
Dengue Fever
About this trial
This is an interventional prevention trial for Dengue Fever focused on measuring Dengue, Dengue fever, Dengue Hemorrhagic Fever, Flavivirus
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- WRAIR, Clinical Trials Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
TDENV-PIV alum4
TDENV-PIV AS01E1
TDENV-PIV AS03B1
Placebo
TDENV-PIV alum1
4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS01E1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with AS03B1 adjuvant; 0.5 mL intramuscular injection at 0 and 28 days
Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days
1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days