Assessment of a Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-LVHC) Virus Strain

Completed · Phase 1

Conditions studied: Dengue

In brief

To evaluate the effectiveness of candidate dengue vaccine formulations, it is prudent to develop an appropriate challenge model. To this end, this first-in-human study will examine the safety and effectiveness of the Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) product and assess the ability of this virus strain to elicit an uncomplicated dengue-like illness.

Key facts

Study ID

NCT02372175

Run by

U.S. Army Medical Research and Development Command

People needed

27

Starts

2015-10-01

Expected to finish

2019-06-28

Last updated by the study team

2019-07-15

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy, male or non-pregnant, non-lactating female
• Age 18-45
• Ability and willingness to sign informed consent
• Passing score on comprehension test would be 75%, with up to 3 attempts
• Available for the study period
• Willing to use contraception for the duration of the study.
• Provide consent for release of medical history records from primary care physician, college or university, urgent care or emergency room visit

You may not qualify if…

• Female: pregnant or lactating
• Heavy menstrual bleeding within the last 6 months-menstrual periods lasting longer than 6 days, or requiring 5 or more pads or tampons per day.
• Female subjects using an intrauterine device (IUD) or Mirena®
• Female subjects with fibroids or uterine polyps, endometriosis, dysmenorrhea, adenomyosis, and uterine scarring (e.g. after D\&C)
• Blood tests confirming infection with human immunodeficiency virus- 1 (HIV-1), hepatitis C, hepatitis B surface antigen, or flavi viruses (FV) to include dengue fever, West Nile, Yellow Fever, and Japanese encephalitis.
• Diabetes, chronic obstructive pulmonary disease (COPD), peptic ulcer disease (PUD), or coronary artery disease (CAD)
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• Immediate family member (e.g. parent, sibling, child) with current, or a history of immunodeficiency or autoimmune disease
• Current or a history of auto-immune disease
• History of Guillain Barré syndrome (GBS)
• Any history of FV infection or FV vaccination; or planned FV vaccination, outside the study protocol, during the study period
• History of Bipolar Disorder, Schizophrenia, hospitalization in the past year for a mental health disorder, or any other psychiatric condition, which in the opinion of the investigator prevents the subject from participating in the study.
• Planned travel during the study period (180 days) which would interfere with the ability to complete all study visits
• Recent (in the past 4 weeks) travel to any dengue endemic area. These potential subjects may be eligible for enrollment a minimum of 4 weeks later
• Any laboratory abnormalities in the tests specified in Table 19 and Table 20 of the protocol. Note: these laboratory tests can be repeated if the screening physician believes 1) it is thought to be a normal variant of a healthy state or 2) it is a suspected laboratory error
• Significant screening physical examination abnormalities at the discretion of the investigator
• Women who intend to become pregnant or men who intend to father a child during the study period (approximately 6 months)
• Hives, shortness of breath, swelling of the lips or throat, or hospitalization related to a previous vaccination or an allergy to specific medications/animals for which antigens may be in the virus preparations to include: shellfish allergy, fetal bovine serum, L-glutamine, neomycin and streptomycin
• Planning to donate blood in the 1 year following inoculation with dengue
• Participation or planned participation in another vaccine, drug, medical device, or medical procedure clinical trial in the 4 weeks prior to this trial, during the trial, or 6 months following inoculation in this clinical trial
• Beliefs that bar the administration of blood products or transfusions
• Positive urine screen for cocaine, amphetamines, or opiates
• Currently taking Methadone or Suboxone
• Currently taking anti-coagulant medication, aspirin or non-steroidal anti-inflammatory drugs (NSAIDs)
• Chronic migraine headaches, defined as more than 15 headache days per month over a 3 month period of which more than 8 are migrainous, in the absence of medication over use

Where it is running

• State University of New York, Upstate Medical University (SUNY-UMU) — Syracuse, New York, United States

Full record on ClinicalTrials.gov

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