VRC 320: A Phase I, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA090-00-VP, Administered Via Needle and Syringe or Needle-free Injector, PharmaJet, inHealthy Adults

This is an interventional prevention trial for Prevention of Zika Infection focused on measuring Zika Infection, Immune Response, Flavivirus, Arthropod-Borne Virus Read More

• INCLUSION CRITERIA:

A subject must meet all of the following criteria:

• 18 to 50 years old
• Available for clinic visits for 24 months after enrollment
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
• Able and willing to complete the informed consent process
• Willing to donate blood for sample storage to be used for future research
• In good general health without clinically significant medical history
• Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) less than or equal to 40 within the 56 days prior to enrollment
• Agrees not to receive licensed or investigational flavivirus vaccines through 4 weeks after last product administration

• Laboratory Criteria within 56 days prior to enrollment:

  • Hemoglobin within institutional normal limits or accompanied by the site Principal Investigator (PI) or designee approval
  • WBC and differential either within institutional normal range or accompanied by site PI or designee approval
  • Total lymphocyte count greater than or equal to 800 cells/mm^3
  • Platelets = 125,000 - 500,000/mm^3
  • Alanine aminotransferase (ALT) less than or equal to 1.25 x institutional upper limit of normal (ULN)
  • Serum creatinine less than or equal to 1.1 x institutional ULN
  • Negative for HIV infection by an FDA approved method of detection

• Criteria applicable to women of childbearing potential:

  • Negative human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on day of enrollment
  • Agrees to use an effective means of birth control from at least 21 days prior to enrollment through 12 weeks after the last study vaccination

EXCLUSION CRITERIA:

A subject will be excluded if one or more of the following conditions apply:

• Female-specific: Breast-feeding or planning to become pregnant while participating through 12 weeks after the last study vaccination

• Subject has received any of the following:

  • More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment
  • Blood products within 16 weeks prior to enrollment
  • Inactivated vaccines within 2 weeks prior to enrollment
  • Live attenuated vaccines within 4 weeks prior to enrollment
  • Investigational research products within 4 weeks prior to enrollment or planning to receive investigational products while on the study
  • Current allergen immunotherapy with antigen injections, unless on maintenance schedule
  • Current anti-TB prophylaxis or therapy

• Subject has a history of any of the following clinically significant conditions:

  • Laboratory confirmed ZIKV infection by self-report at the time of enrollment
  • Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the site investigator
  • Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
  • Asthma that is not well controlled
  • Diabetes mellitus (type I or II), with the exception of gestational diabetes
  • Evidence of autoimmune disease or immunodeficiency
  • Idiopathic urticaria within the past year
  • Hypertension that is not well controlled
  • Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
  • Malignancy that is active or history of malignancy that is likely to recur during the period of the study
  • Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years
  • Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
  • Guillain-Barre Syndrome, Bell's palsy or similar neurological conditions
  • Psychiatric condition that precludes compliance with the protocol; past or present psychoses; or within 5 years prior to enrollment, a history of suicide plan or attempt
  • Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent