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

Inclusion Criteria:

1. Healthy, male or non-pregnant, non-lactating female

2. Age 18-45

3. Ability and willingness to sign informed consent

4. Passing score on comprehension test would be 75%, with up to 3 attempts

5. Available for the study period

6. Willing to use contraception for the duration of the study.

7. Provide consent for release of medical history records from primary care physician,
college or university, urgent care or emergency room visit

Exclusion Criteria:

1. Female: pregnant or lactating

2. 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.

3. Female subjects using an intrauterine device (IUD) or Mirena®

4. Female subjects with fibroids or uterine polyps, endometriosis, dysmenorrhea,
adenomyosis, and uterine scarring (e.g. after D&C)

5. 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.

6. Diabetes, chronic obstructive pulmonary disease (COPD), peptic ulcer disease (PUD), or
coronary artery disease (CAD)

7. 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)

8. Immediate family member (e.g. parent, sibling, child) with current, or a history of
immunodeficiency or autoimmune disease

9. Current or a history of auto-immune disease

10. History of Guillain Barré syndrome (GBS)

11. Any history of FV infection or FV vaccination; or planned FV vaccination, outside the
study protocol, during the study period

12. 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.

13. Planned travel during the study period (180 days) which would interfere with the
ability to complete all study visits

14. 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

15. 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

16. Significant screening physical examination abnormalities at the discretion of the
investigator

17. Women who intend to become pregnant or men who intend to father a child during the
study period (approximately 6 months)

18. 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

19. Planning to donate blood in the 1 year following inoculation with dengue

20. 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

21. Beliefs that bar the administration of blood products or transfusions

22. Positive urine screen for cocaine, amphetamines, or opiates

23. Currently taking Methadone or Suboxone

24. Currently taking anti-coagulant medication, aspirin or non-steroidal anti-inflammatory
drugs (NSAIDs)

25. 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

26. Chronic medical condition that, in the opinion of the investigator impacts subject
safety.