Comparison of Tetravalent Dengue Virus Purified Inactivated Vaccine and Tetravalent Dengue Virus Live Attenuated Vaccine

Status unconfirmed · Phase 1

Conditions studied: Dengue Virus

In brief

This study is a Phase 1, randomized, open-label study of the prime-boost vaccine candidates given in the prime-boost regimen previously demonstrated to have a high level of immunogenicity and immune durability: Day 0 prime (PIV) and Day 180 boost (LAV), and compare it with a previously untested schedule: Day 0 prime (PIV) and Day 90 boost (LAV) in order to define the potential tradeoff between potential immunogenicity, including cell-mediated immunity, and a more practical dosing schedule.

Key facts

Study ID

NCT03141138

Run by

U.S. Army Medical Research and Development Command

People needed

40

Starts

2017-11-08

Expected to finish

2021-12-31

Last updated by the study team

2021-03-26

Who can join

Age: 18 and older, up to 42. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female between 18 and 42 years of age (inclusive) at the time of consent
• Able to provide written informed consent
• Healthy as established by medical history and clinical examination and basic hematologic laboratory analysis before entering into the study
• Able and willing to comply with the requirements of the protocol (eg, document events in memory aid, return for follow-up visits, etc.)
• Dengue exposure naïve as established by pre-enrollment dengue PRNT testing and questioning of volunteer
• Female subject of non-childbearing potential (non-childbearing potential is defined as having either a current bilateral tubal ligation at least 3 months prior to enrollment or a history of an hysterectomy, bilateral oophorectomy, or is post-menopause(12 months or more since last menstrual period)) or Female subject of childbearing potential may be enrolled in the study, if the subject has:
• Practiced adequate contraception for 30 days prior to vaccinations, and
• A negative urine pregnancy test on each day of vaccination, and
• Agreed to continue adequate contraception through at least 3 months following last vaccination

You may not qualify if…

• Use of any investigational or non-registered product (drug or vaccine or device) other than the study vaccines during the period starting 30 days preceding the first dose of study vaccine and/or planned use during the study period
• Chronic administration (defined as more than 14 days in total) of prescription immunosuppressants or other prescription immune-modifying drugs during the period starting 180 days prior to the first vaccine dose
• For corticosteroids, this will mean prednisone ≥ 20 mg/d or equivalent
• Inhaled and topical steroids are allowed
• History of or active use of cancer chemotherapy or radiation therapy for the treatment of cancer
• Receipt or planned receipt of a vaccine/product outside the study protocol within 30 days of each scheduled dose of an investigational product
• Planned administration of any flavivirus vaccine, to include licensed vaccines for Yellow Fever or Japanese Encephalitis Virus as well as other investigational vaccines for dengue, Zika, West Nile, other flavivirus, for the entire study duration
• Previous receipt of a foreign or investigational dengue 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
• History of, or current, auto-immune disease
• History of any reaction or hypersensitivity likely to be triggered by any component of the vaccines or related to a study procedure (This includes hypersensitivity reactions to alum, streptomycin, neomycin, or any other flavivirus vaccine, such as Yellow Fever virus and Japanese Encephalitis virus vaccines)
• Major congenital defects or serious chronic illness
• History of any chronic neurological disorders or chronic and/or uncontrolled seizures
• Acute infectious disease and/or fever (oral body temperature ≥ 100.4°F/38.0°C) at the time of enrollment (a subject with a minor illness, ie, 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 history, physical examination or laboratory screening tests
• Receipt of immunoglobulins or any blood products during the period starting 90 days preceding the first dose of study vaccine or planned receipt during the study period
• Donated blood within 8 weeks before first scheduled investigational vaccine receipt or planned donation of blood products throughout the study period
• History of chronic alcohol abuse and/or drug abuse that, in the opinion of the investigator, could result in poor compliance with study requirements.
• Pregnant or breastfeeding female or female planning to become pregnant or planning to discontinue contraceptive precautions
• A planned move to a location that will prohibit compliance with the requirements of the trial
• 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:
• > 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

Where it is running

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

Full record on ClinicalTrials.gov

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