From: Phase 1 trial to model primary, secondary, and tertiary dengue using a monovalent vaccine
Inclusion criteria | Exclusion criteria |
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1. Aged 18 to 59 years. 2. In good general health as evidenced by medical history, physical examination, and laboratory screening resultsa. 3. Willing to allow storage of samples and data for future research. 4. Willing to forgo receipt of any vaccine in the 28 days preceding the vaccine or in the 28 days following the dose of vaccine. For participants opting for LN FNA on day 57, they must be willing to forgo any vaccine through final LN FNA. 5. For individuals who can become pregnant: use of at least one method of highly effective contraceptionb from the invitation to participate in the trial through day 28 after vaccination. 6. Able to provide informed consent. 7. Willing to adhere to lifestyle considerationsc for the duration of the study. 8. Willing to avoid travel to a dengue-endemic areas as defined by the Centers for Disease Control and Prevention (CDC) for the duration of their participation in the study. 9. Absolute neutrophil count (ANC) > 750 cells/µL. 10. Creatinine < 1.5 mg/dL. 11. ALT < 1.25 × upper limit of normal. 12. Flavivirus-naïve or serologic evidence of either one previous DENV1, 2, or 4 infection or infection with at least two different serotypes. 13. Agree to avoid participation in other clinical studies requiring investigational interventions for the duration of this study (180 days). 14. Agree to avoid blood and plasma donation outside this study through day 28. | 1. Pregnant at screening. 2. History of or positive test result for HIV, hepatitis B, or hepatitis C. 3. History of previous DENV vaccination 4. Any medical, psychiatric, or social condition that, in the judgement of the investigator, is a contraindication to protocol participation. 5. Has any of the following:  a) More than 10 days of systemic immunosuppressive medications (≥ 10 mg prednisone dose or its equivalent) or cytotoxic medication within the 30 days prior to vaccination or immunomodulating therapyd within 180 days prior to vaccination.  b) Received blood products, including immunoglobulin products, within 120 days prior to vaccination.  c) History of serious reactions to vaccines.  d) Hereditary, acquired, or idiopathic forms of angioedema.  e) Idiopathic urticaria within the past year.  f) Asthma that is not well controlled or required emergency care, urgent care, hospitalization, or intubation during the past two years or that requires the use of oral or intravenous steroids.  g) Type 1 or type 2 diabetes mellitus that is not well controlled (hemoglobin A1c > 8).  h) Clinically significant autoimmune disease or immunodeficiency.  i) Blood pressure ≥ 180/110 (stage 3 hypertension) on at least 2 measures.  j) Documented diagnosis of a bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions).  k) Significant bruising or bleeding difficulties with subcutaneous injections or blood draws.  l) Malignancy that is active or treated malignancy for which there is no reasonable assurance of sustained cure, or malignancy that is likely to recur during the study period.  m) Asplenia or functional asplenia.  n) History of alcohol or drug abuse or addiction and/or positive drug screen with substances other than marijuana. |