VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents (DNA)
Zika Virus, Zika Virus Infection, Virus Diseases
About this trial
This is an interventional prevention trial for Zika Virus focused on measuring Flavivirus, Zika, Vaccine, Physiological Effects of Drugs, Immunologic Factors, Virus-like Particles, Zika vaccine
Eligibility Criteria
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
Exclusion Criteria:
Criteria applicable to women and adolescents of childbearing potential:
• Breast-feeding or planning to become pregnant while participating through 12 weeks after the last product administration
Participant has received any of the following:
- More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to randomization
- Any systemic immunosuppressive medications or cytotoxic medications within the 14 days prior to randomization
- Blood products within 16 weeks prior to randomization
- Immunoglobulin within 8 weeks prior to randomization
- Investigational research agents within 4 weeks prior to randomization or planning to receive investigational products while on the study
- Any vaccination within 2 weeks prior to randomization
- Any live attenuated vaccination within 4 weeks prior to randomization
- Current anti-tuberculosis (TB) prophylaxis or therapy
Participant has any of the following:
- Confirmed history of ZIKV infection (as reported by participant)
- Serious reactions to vaccines
- Chronic angioedema or chronic urticaria
- Asthma that is not well-controlled
- Diabetes mellitus (type I or II)
- Clinically significant autoimmune disease or immunodeficiency
- Hypertension that is not well-controlled
- Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
- Significant bruising or bleeding difficulties with IM injections or blood draws
- Malignancy that is active or history of a malignancy that is likely to recur during the period of the study
- Seizure or treatment for a seizure disorder within the last 3 years
- Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
- History of Guillain-Barré Syndrome
- Psychiatric condition that may preclude compliance with the protocol; past or present psychoses; or a history of suicide plan or attempt within 5 years prior to randomization
- Any medical psychiatric, or social condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a participant's ability to give informed consent
Sites / Locations
- QPS-Miami Research Associates
- Doctors Hospital at Renaissance
- Baylor College of Medicine
- Hospital Das Clinicas Da Universidade Federal de Minas Gerais
- Centro de Pesquisas Clínicas Do Instituto Central Do Hospital Das Clínicas Da FMUSP
- Clinica de la Costa Ltda
- Centro de Atencion y Diagnostico de Enfermedades Infecciosas
- CCIM Costa Rican Center Center of Medical Research, Sociedad Anonima
- AGA Clinical Centro de Investigaciones
- Hospital Civil Fray Antonio Alcalde
- Instituto Conmemorativo Gorgas
- Asociacion Civil Selva Amazonica
- Unidad de Ensayos (UNIDEC) del Policlinico Universidad Nacional Mayor de San Marcos
- Ponce Medical School Foundation Inc./CAIMED Center
- Fundación de Investigación de Diego
- San Juan Hospital Research Unit
- Puerto Rico Clinical and Translational Research Consortium
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 injections
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 injections
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 injections
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 injections
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 injections
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device