VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents

Inclusion Criteria

• •A participant must meet all of the following criteria:
• •Part A:
• •18 to 35 years of age
• •Available for clinical follow-up through Study Week 32
• •Accessible injection sites on each limb as follows: 1 injection site in the deltoid muscle of each arm and 1 injection site in the vastus lateralis muscle of each anterolateral thigh
• •Part B:
• •15 to 35 years of age
• •Available for clinical follow-up through Study Week 96
• •Accessible injection sites on the deltoid muscle of each arm. Injection in the vastus lateralis muscle of the anterolateral thighs may have been allowed with IND Sponsor approval if an injection site on each deltoid muscle was not available.
• •Part A and B:
• •Able to provide proof of identity to the satisfaction of the clinician completing the enrollment process
• •Able and willing to complete the informed consent/assent process
• •Able and willing to complete the Assessment of Understanding and to verbalize understanding of all questions answered incorrectly prior to signing consent/assent
• •Willing to donate blood and urine to be stored and used for future research
• •In good general health without clinically significant medical history
• •Physical examination and laboratory results without clinically significant findings within the 56 days prior to randomization
• •Weight \>30 kilograms (kg)
• •Agree not to receive any licensed or investigational flavivirus vaccines through 4 weeks after last product administration
• •Laboratory Criteria within 56 days prior to randomization:
• •Hemoglobin within site institutional normal limits
• •Absolute neutrophil count (ANC) within site institutional normal limits
• •Total lymphocyte count ≥800 cells/mm\^3
• •Platelets = 125,000-510,000 cells/mm\^3
• •Alanine aminotransferase (ALT) ≤1.5 x upper limit of normal (ULN) based on site institutional normal range for respective age group
• •Serum creatinine ≤1.2 x ULN based on site institutional normal range for respective age group
• •Negative result on a human immunodeficiency virus (HIV) test that meets local standards for identification of HIV infection
• •Criteria applicable to women and adolescents of childbearing potential:
• •Negative result on a human chorionic gonadotropin pregnancy test (urine or serum) on day of randomization before receiving study product
• •Agree to use effective means of birth control from at least 21 days before randomization through 12 weeks after the last product administration
• •Criteria applicable to adolescents:
• •Capability of the parent/guardian of the minor to understand and comply with planned study procedures
• •Capability of the minor and their parent/guardian to provide informed consent/assent