Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA085-00-VP, in Healthy Adults

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

• INCLUSION CRITERIA:

  1. 18 to 35 years old
  2. Available for clinic visits for 24 months after enrollment
  3. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
  4. Able and willing to complete the informed consent process
  5. Willing to donate blood for sample storage to be used for future research
  6. In good general health without clinically significant medical history
  7. 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

  8. Agrees not to receive licensed or investigational flavivirus vaccines through 4 weeks after last study injection

     INCLUSION CRITERIA - LABORATORY CRITERIA WITHIN 56 DAYS PRIOR TO ENROLLMENT:

  9. Hemoglobin within institutional normal limits or accompanied by the site PI or designee approval
  10. WBC and differential either within institutional normal range or accompanied by site PI or designee approval
  11. Total lymphocyte count greater than or equal to 800 cells/mm^3
  12. Platelets = 125,000 - 500,000/mm^3
  13. Alanine aminotransferase (ALT) less than or equal to 1.25 x institutional upper limit of normal (ULN)
  14. Serum creatinine less than or equal to 1.1 x institutional ULN

  15. Negative for HIV infection by an FDA approved method of detection

      INCLUSION CRITERIA - CRITERIA APPLICABLE TO WOMEN OF CHILDBEARING POTENTIAL:

  16. Negative human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on day of enrollment
  17. 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 - FEMALE-SPECIFIC:

1. Breast-feeding or planning to become pregnant while participating through 12 weeks after the last study vaccination

   EXCLUSION CRITERIA - SUBJECT HAS RECEIVED ANY OF THE FOLLOWING:

2. 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
3. Blood products within 16 weeks prior to enrollment
4. Inactivated vaccines within 2 weeks prior to enrollment
5. Live attenuated vaccines within 4 weeks prior to enrollment
6. Investigational research products within 4 weeks prior to enrollment or planning to receive investigational products while on the study
7. Current allergen immunotherapy with antigen injections, unless on maintenance schedule

8. Current anti-TB prophylaxis or therapy

   EXCLUSION CRITERIA - SUBJECT HAS A HISTORY OF ANY OF THE FOLLOWING CLINICALLY SIGNIFICANT CONDITIONS:

9. Laboratory confirmed ZIKV infection by self-report
10. Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the site investigator
11. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
12. Asthma that is not well controlled
13. Diabetes mellitus (type I or II), with the exception of gestational diabetes
14. Evidence of autoimmune disease or immunodeficiency
15. Idiopathic urticaria within the past year
16. Hypertension that is not well controlled
17. 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
18. Malignancy that is active or history of malignancy that is likely to recur during the period of the study
19. 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
20. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
21. Guillain-Barre Syndrome, Bell s palsy or similar neurological conditions
22. 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
23. 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