A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults (in Puerto Rico)
This trial is active, not recruiting.
|Treatments||biological/vaccine: 4 µg tdenv-piv with alum adjuvant, biological/vaccine: 1 µg tdenv-piv with as03b adjuvant, phosphate buffered saline, 1 µg tdenv-piv with alum adjuvant, 1 µg tdenv-piv with as01e adjuvant|
|Sponsor||U.S. Army Medical Research and Materiel Command|
|Start date||November 2012|
|End date||December 2016|
|Trial size||100 participants|
|Trial identifier||NCT01702857, 116614, DPIV-002, S-12-12, WRAIR 1945|
This is a first time in humans (FTiH) study designed to assess the experimental TDENV-PIV vaccine in a predominantly dengue-primed adult population. The study is designed to afford a first time in humans (FTiH) safety and immunogenicity assessment of three TDENV-PIV vaccine candidates, each formulated with a different adjuvant: either aluminum hydroxide, AS01E or AS03B (adjuvants used in GSK Biologicals' hepatitis B candidate vaccine, malaria candidate vaccine and pandemic flu vaccine, respectively). Each vaccine candidate will contain 1 µg of purified virus antigen per each of the four DENV types. Additionally, the study will evaluate an alum adjuvanted TDENV-PIV vaccine candidate containing 4 µg of purified virus antigen per each of the four DENV types. The control group will receive a saline placebo. All experimental vaccinations will be administered according to a 2-dose schedule, 28 days apart. There is a parallel FTiH study that is conducted in the United States in a dengue-naive population using the same investigational vaccines.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Safety and reactogenicity of various TDENV-PIV formulations from Day 0 through 28 days after the second dose (Day 0 - Day 56)
time frame: Up to Day 56
Humoral immunogenicity to each of four DENV types of various TDENV-PIV formulations 28 days after the second dose (Day 56)
time frame: Day 56
Safety of various TDENV-PIV formulations, from Day 0 to Month 13 (Visits 1-11)
time frame: Up to month 13
Humoral immunogenicity to each of four DENV types of various TDENV-PIV formulations on Days 0, 7 and 28 and Months 7 and 13
time frame: Up to month 13
• To evaluate the safety of various TDENV-PIV formulations from Month 14 through the end of the study (Visit 15)
time frame: Up to the end of study (Month 37-39)
Male or female participants from 20 years up to 39 years old.
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 20 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 - Subject has lived in the Caribbean for more than 10 years - 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). - 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 Exclusion: - 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) - Previous or planned administration of any other flavivirus vaccine (approved or investigational) for the entire study duration - Previous receipt of any investigational dengue virus vaccine - 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 normal limits for their age, gender, and locality at screening.
|Official title||A Phase I, Randomized, Placebo-Controlled, Observer-blind, Two-dose (0-28 Day Schedule) Primary Vaccination Study of WRAIR Tetravalent Dengue Virus Purified Inactivated Vaccine (TDENV-PIV) in Healthy Adults in Puerto Rico|
|Principal investigator||Clemente Diaz, MD|
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