<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02996461</url>
  </required_header>
  <id_info>
    <org_study_id>170024</org_study_id>
    <secondary_id>17-I-0024</secondary_id>
    <nct_id>NCT02996461</nct_id>
  </id_info>
  <brief_title>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</brief_title>
  <official_title>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, in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      People get Zika virus from infected mosquitos. They usually don t get very sick. But birth&#xD;
      defects were reported in babies born to mothers who had Zika infection. In rare cases, people&#xD;
      with Zika infection had a nervous system disease that causes severe muscle weakness and can&#xD;
      be life threatening. A new vaccine made from DNA in the code for a Zika virus protein could&#xD;
      help the body build an immune response against the virus.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To see if a new vaccine against Zika virus disease is safe and causes any side effects. To&#xD;
      study specific immune responses to the vaccine.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Healthy people ages 18-50&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with:&#xD;
&#xD;
      Medical history&#xD;
&#xD;
      Physical exam&#xD;
&#xD;
      Urine tests&#xD;
&#xD;
      Participants will have 18 visits over 2 years.&#xD;
&#xD;
      Participants will be randomly assigned to 1 of 3 groups. All will get 3 vaccines at 3&#xD;
      separate monthly visits. They will receive the vaccine in the upper arm muscle. Some will get&#xD;
      it by needle and syringe, others by a device that uses high pressure to push the vaccine&#xD;
      through the skin.&#xD;
&#xD;
      Vaccine visits last 4-6 hours. Participants will get a thermometer to measure their&#xD;
      temperature and a ruler to measure any skin changes at the injection site. They will record&#xD;
      this data for 7 days after each injection.&#xD;
&#xD;
      Other visits last 1-2 hours. These include:&#xD;
&#xD;
      Evaluation of any health changes or problems&#xD;
&#xD;
      Blood tests: Some samples may be used for future research.&#xD;
&#xD;
      Participants with side effects may have extra visits.&#xD;
&#xD;
      ...&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      STUDY DESIGN:&#xD;
&#xD;
      This is a Phase I, randomized clinical study to evaluate the safety, tolerability, and&#xD;
      immunogenicity of a 3 dose vaccination regimen with the Zika virus (ZIKVwt) DNA vaccine,&#xD;
      VRC-ZKADNA090-00-VP. Subjects will be randomized to one of three groups to receive a full 4&#xD;
      mg dose: 1) full dose by one intramuscular (IM) injection with needle and syringe; 2) split&#xD;
      dose given as two 0.5 mL IM injections with needle and syringe; 3) split dose given as two&#xD;
      0.5 mL IM injections with PharmaJet, a needle-free injection device. The primary hypothesis&#xD;
      is that the investigational ZIKVwt DNA vaccine will be safe and well tolerated in healthy&#xD;
      adults. A secondary hypothesis is that the vaccine will elicit a ZIKV-specific immune&#xD;
      response. The primary objectives are to evaluate the safety and tolerability of the vaccine&#xD;
      in healthy adults. Secondary objectives are related to the immunogenicity of the vaccine and&#xD;
      vaccination regimens.&#xD;
&#xD;
      PRODUCT DESCRIPTION:&#xD;
&#xD;
      The investigational vaccine, VRC-ZKADNA090-00-VP, was developed by the Vaccine Research&#xD;
      Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), National&#xD;
      Institutes of Health (NIH) and is composed of a single closed-circular DNA plasmid (VRC 5283)&#xD;
      that encodes the wild type (wt) precursor membrane M (prM) and envelope (E) proteins from the&#xD;
      H/PF/2013 strain of ZIKV. ZIKVwt&#xD;
&#xD;
      SUBJECTS:&#xD;
&#xD;
      Healthy adults 18 to 50 years of age.&#xD;
&#xD;
      STUDY PLAN:&#xD;
&#xD;
      Forty-five subjects will be enrolled at the NIH Clinical Center and randomized to 3 groups to&#xD;
      receive study product on Day 0, Week 4 and Week 8. The protocol requires about 18 scheduled&#xD;
      clinic visits and a telephone follow-up contact after each study product administration.&#xD;
      Solicited reactogenicity will be evaluated using a 7-day diary card. Assessment of vaccine&#xD;
      safety will include clinical observation and monitoring of hematological and chemical&#xD;
      parameters at clinical visits throughout the study.&#xD;
&#xD;
      VRC 320 STUDY SCHEMA:&#xD;
&#xD;
        -  Group 1:&#xD;
&#xD;
             -  Administration Method = Single Dose Needle and Syringe;&#xD;
&#xD;
             -  Subjects = 15;&#xD;
&#xD;
             -  Administration Schedule = Day 0 (ZIKVwt DNA(1 (1 mL) injection)), Week 4 (ZIKVwt&#xD;
                DNA (1 (1 mL) injection)), Week 8 (ZIKVwt DNA (1 (1 mL) injection))&#xD;
&#xD;
        -  Group 2:&#xD;
&#xD;
             -  Administration Method = Split Dose Needle and Syringe;&#xD;
&#xD;
             -  Subjects = 15;&#xD;
&#xD;
             -  Administration Schedule = Day 0 (ZIKVwt DNA(2 (0.5 mL) injections)), Week 4 (ZIKVwt&#xD;
                DNA (2 (0.5 mL) injections)), Week 8 (ZIKVwt DNA (2 (0.5 mL) injections))&#xD;
&#xD;
        -  Group 3:&#xD;
&#xD;
             -  Administration Method = Split Dose PharmaJet;&#xD;
&#xD;
             -  Subjects = 15;&#xD;
&#xD;
             -  Administration Schedule = Day 0 (ZIKVwt DNA(2 (0.5 mL) injections)), Week 4 (ZIKVwt&#xD;
                DNA (2 (0.5 mL) injections)), Week 8 (ZIKVwt DNA (2 (0.5 mL) injections))&#xD;
&#xD;
             -  Subjects Total = 45 (All injections total a dose of 4 mg. ** Up to 50 total&#xD;
                enrollments are permitted if additional subjects are needed to assess safety or&#xD;
                immunogenicity.)&#xD;
&#xD;
      STUDY DURATION:&#xD;
&#xD;
      Subjects will be evaluated for safety and immune responses throughout the study for 44 weeks&#xD;
      following the first vaccine administration. Durability of immune responses will be evaluated&#xD;
      at two long term follow-up visits, occurring at 18 and 24 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 12, 2016</start_date>
  <completion_date type="Actual">September 3, 2019</completion_date>
  <primary_completion_date type="Actual">September 3, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the safety and tolerability of v ZIKV DNA vaccine administered at 4mg IM by needle and syringe.</measure>
    <time_frame>Through 44 weeks of study participation.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate the safety and tolerability of ZIKV DNA vaccine administered at 4 mg IM by Pharma jet.</measure>
    <time_frame>Through 44 weeks of study participation.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the magnitude and the frequency of ZIKV-specific antibody response as measured by neutralization assay.</measure>
    <time_frame>Four weeks after the first, second and third injections for each regimen.</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Prevention of Zika Infection</condition>
  <condition>Zika-Specific Immune Response</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ZIKV DNA vaccine administered IM via needle and syringe at a single dosage of 4 mg on Day 0, week 4 and week 8.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ZIKV DNA vaccine administered IM via needle and syringe as a split dose of two .5 ml injections on Day 0, week 4 and week 8.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ZIKV DNA vaccine administered IM via needle-free injection device, PharmaJet, as a split dose of two .5 ml injections on Day 0, week 4 and week 8.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VRC-ZKADNA090-00-VP</intervention_name>
    <description>VRC-ZKADNA090-00-VP is an investigational ZIKV DNA vaccine that is intended to prevent Zika virus infection.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        A subject must meet all of the following criteria:&#xD;
&#xD;
          -  18 to 50 years old&#xD;
&#xD;
          -  Available for clinic visits for 24 months after enrollment&#xD;
&#xD;
          -  Able to provide proof of identity to the satisfaction of the study clinician&#xD;
             completing the enrollment process&#xD;
&#xD;
          -  Able and willing to complete the informed consent process&#xD;
&#xD;
          -  Willing to donate blood for sample storage to be used for future research&#xD;
&#xD;
          -  In good general health without clinically significant medical history&#xD;
&#xD;
          -  Physical examination and laboratory results without clinically significant findings&#xD;
             and a Body Mass Index (BMI) less than or equal to 40 within the 56 days prior to&#xD;
             enrollment&#xD;
&#xD;
          -  Agrees not to receive licensed or investigational flavivirus vaccines through 4 weeks&#xD;
             after last product administration&#xD;
&#xD;
          -  Laboratory Criteria within 56 days prior to enrollment:&#xD;
&#xD;
               -  Hemoglobin within institutional normal limits or accompanied by the site&#xD;
                  Principal Investigator (PI) or designee approval&#xD;
&#xD;
               -  WBC and differential either within institutional normal range or accompanied by&#xD;
                  site PI or designee approval&#xD;
&#xD;
               -  Total lymphocyte count greater than or equal to 800 cells/mm^3&#xD;
&#xD;
               -  Platelets = 125,000 - 500,000/mm^3&#xD;
&#xD;
               -  Alanine aminotransferase (ALT) less than or equal to 1.25 x institutional upper&#xD;
                  limit of normal (ULN)&#xD;
&#xD;
               -  Serum creatinine less than or equal to 1.1 x institutional ULN&#xD;
&#xD;
               -  Negative for HIV infection by an FDA approved method of detection&#xD;
&#xD;
          -  Criteria applicable to women of childbearing potential:&#xD;
&#xD;
               -  Negative human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum)&#xD;
                  on day of enrollment&#xD;
&#xD;
               -  Agrees to use an effective means of birth control from at least 21 days prior to&#xD;
                  enrollment through 12 weeks after the last study vaccination&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        A subject will be excluded if one or more of the following conditions apply:&#xD;
&#xD;
          -  Female-specific: Breast-feeding or planning to become pregnant while participating&#xD;
             through 12 weeks after the last study vaccination&#xD;
&#xD;
          -  Subject has received any of the following:&#xD;
&#xD;
               -  More than 10 days of systemic immunosuppressive medications or cytotoxic&#xD;
                  medications within the 4 weeks prior to enrollment or any within the 14 days&#xD;
                  prior to enrollment&#xD;
&#xD;
               -  Blood products within 16 weeks prior to enrollment&#xD;
&#xD;
               -  Inactivated vaccines within 2 weeks prior to enrollment&#xD;
&#xD;
               -  Live attenuated vaccines within 4 weeks prior to enrollment&#xD;
&#xD;
               -  Investigational research products within 4 weeks prior to enrollment or planning&#xD;
                  to receive investigational products while on the study&#xD;
&#xD;
               -  Current allergen immunotherapy with antigen injections, unless on maintenance&#xD;
                  schedule&#xD;
&#xD;
               -  Current anti-TB prophylaxis or therapy&#xD;
&#xD;
          -  Subject has a history of any of the following clinically significant conditions:&#xD;
&#xD;
               -  Laboratory confirmed ZIKV infection by self-report at the time of enrollment&#xD;
&#xD;
               -  Serious reactions to vaccines that preclude receipt of study vaccinations as&#xD;
                  determined by the site investigator&#xD;
&#xD;
               -  Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema&#xD;
&#xD;
               -  Asthma that is not well controlled&#xD;
&#xD;
               -  Diabetes mellitus (type I or II), with the exception of gestational diabetes&#xD;
&#xD;
               -  Evidence of autoimmune disease or immunodeficiency&#xD;
&#xD;
               -  Idiopathic urticaria within the past year&#xD;
&#xD;
               -  Hypertension that is not well controlled&#xD;
&#xD;
               -  Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or&#xD;
                  platelet disorder requiring special precautions) or significant bruising or&#xD;
                  bleeding difficulties with IM injections or blood draws&#xD;
&#xD;
               -  Malignancy that is active or history of malignancy that is likely to recur during&#xD;
                  the period of the study&#xD;
&#xD;
               -  Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to&#xD;
                  alcohol withdrawal more than 3 years ago, or 3) seizures that have not required&#xD;
                  treatment within the last 3 years&#xD;
&#xD;
               -  Asplenia, functional asplenia or any condition resulting in the absence or&#xD;
                  removal of the spleen&#xD;
&#xD;
               -  Guillain-Barre Syndrome, Bell's palsy or similar neurological conditions&#xD;
&#xD;
               -  Psychiatric condition that precludes compliance with the protocol; past or&#xD;
                  present psychoses; or within 5 years prior to enrollment, a history of suicide&#xD;
                  plan or attempt&#xD;
&#xD;
               -  Any medical, psychiatric, social condition, occupational reason or other&#xD;
                  responsibility that, in the judgment of the investigator, is a contraindication&#xD;
                  to protocol participation or impairs a volunteer's ability to give informed&#xD;
                  consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Grace L Chen, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Allergy and Infectious Diseases (NIAID)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Dowd KA, Ko SY, Morabito KM, Yang ES, Pelc RS, DeMaso CR, Castilho LR, Abbink P, Boyd M, Nityanandam R, Gordon DN, Gallagher JR, Chen X, Todd JP, Tsybovsky Y, Harris A, Huang YS, Higgs S, Vanlandingham DL, Andersen H, Lewis MG, De La Barrera R, Eckels KH, Jarman RG, Nason MC, Barouch DH, Roederer M, Kong WP, Mascola JR, Pierson TC, Graham BS. Rapid development of a DNA vaccine for Zika virus. Science. 2016 Oct 14;354(6309):237-240. doi: 10.1126/science.aai9137. Epub 2016 Sep 22.</citation>
    <PMID>27708058</PMID>
  </reference>
  <reference>
    <citation>Ledgerwood JE, Graham BS. DNA vaccines: a safe and efficient platform technology for responding to emerging infectious diseases. Hum Vaccin. 2009 Sep;5(9):623-6. doi: 10.4161/hv.8627. No abstract available.</citation>
    <PMID>19779298</PMID>
  </reference>
  <reference>
    <citation>Graham BS, Ledgerwood JE, Nabel GJ. Vaccine development in the twenty-first century: changing paradigms for elusive viruses. Clin Pharmacol Ther. 2009 Sep;86(3):234-6. doi: 10.1038/clpt.2009.128.</citation>
    <PMID>19707212</PMID>
  </reference>
  <verification_date>September 3, 2019</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 14, 2019</last_update_submitted>
  <last_update_submitted_qc>December 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Zika Infection</keyword>
  <keyword>Immune Response</keyword>
  <keyword>Flavivirus</keyword>
  <keyword>Arthropod-Borne Virus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zika Virus Infection</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02996461
org study id: 170024
secondary id: 17-I-0024
nct id: NCT02996461
lead sponsor: 
is fda regulated drug: Yes
Background:

      People get Zika virus from infected mosquitos. They usually don t get very sick. But birth
      defects were reported in babies born to mothers who had Zika infection. In rare cases, people
      with Zika infection had a nervous system disease that causes severe muscle weakness and can
      be life threatening. A new vaccine made from DNA in the code for a Zika virus protein could
      help the body build an immune response against the virus.

      Objectives:

      To see if a new vaccine against Zika virus disease is safe and causes any side effects. To
      study specific immune responses to the vaccine.

      Eligibility:

      Healthy people ages 18-50

      Design:

      Participants will be screened with:

      Medical history

      Physical exam

      Urine tests

      Participants will have 18 visits over 2 years.

      Participants will be randomly assigned to 1 of 3 groups. All will get 3 vaccines at 3
      separate monthly visits. They will receive the vaccine in the upper arm muscle. Some will get
      it by needle and syringe, others by a device that uses high pressure to push the vaccine
      through the skin.

      Vaccine visits last 4-6 hours. Participants will get a thermometer to measure their
      temperature and a ruler to measure any skin changes at the injection site. They will record
      this data for 7 days after each injection.

      Other visits last 1-2 hours. These include:

      Evaluation of any health changes or problems

      Blood tests: Some samples may be used for future research.

      Participants with side effects may have extra visits.

      ...
STUDY DESIGN:

      This is a Phase I, randomized clinical study to evaluate the safety, tolerability, and
      immunogenicity of a 3 dose vaccination regimen with the Zika virus (ZIKVwt) DNA vaccine,
      VRC-ZKADNA090-00-VP. Subjects will be randomized to one of three groups to receive a full 4
      mg dose: 1) full dose by one intramuscular (IM) injection with needle and syringe; 2) split
      dose given as two 0.5 mL IM injections with needle and syringe; 3) split dose given as two
      0.5 mL IM injections with PharmaJet, a needle-free injection device. The primary hypothesis
      is that the investigational ZIKVwt DNA vaccine will be safe and well tolerated in healthy
      adults. A secondary hypothesis is that the vaccine will elicit a ZIKV-specific immune
      response. The primary objectives are to evaluate the safety and tolerability of the vaccine
      in healthy adults. Secondary objectives are related to the immunogenicity of the vaccine and
      vaccination regimens.

      PRODUCT DESCRIPTION:

      The investigational vaccine, VRC-ZKADNA090-00-VP, was developed by the Vaccine Research
      Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), National
      Institutes of Health (NIH) and is composed of a single closed-circular DNA plasmid (VRC 5283)
      that encodes the wild type (wt) precursor membrane M (prM) and envelope (E) proteins from the
      H/PF/2013 strain of ZIKV. ZIKVwt

      SUBJECTS:

      Healthy adults 18 to 50 years of age.

      STUDY PLAN:

      Forty-five subjects will be enrolled at the NIH Clinical Center and randomized to 3 groups to
      receive study product on Day 0, Week 4 and Week 8. The protocol requires about 18 scheduled
      clinic visits and a telephone follow-up contact after each study product administration.
      Solicited reactogenicity will be evaluated using a 7-day diary card. Assessment of vaccine
      safety will include clinical observation and monitoring of hematological and chemical
      parameters at clinical visits throughout the study.

      VRC 320 STUDY SCHEMA:

        -  Group 1:

             -  Administration Method = Single Dose Needle and Syringe;

             -  Subjects = 15;

             -  Administration Schedule = Day 0 (ZIKVwt DNA(1 (1 mL) injection)), Week 4 (ZIKVwt
                DNA (1 (1 mL) injection)), Week 8 (ZIKVwt DNA (1 (1 mL) injection))

        -  Group 2:

             -  Administration Method = Split Dose Needle and Syringe;

             -  Subjects = 15;

             -  Administration Schedule = Day 0 (ZIKVwt DNA(2 (0.5 mL) injections)), Week 4 (ZIKVwt
                DNA (2 (0.5 mL) injections)), Week 8 (ZIKVwt DNA (2 (0.5 mL) injections))

        -  Group 3:

             -  Administration Method = Split Dose PharmaJet;

             -  Subjects = 15;

             -  Administration Schedule = Day 0 (ZIKVwt DNA(2 (0.5 mL) injections)), Week 4 (ZIKVwt
                DNA (2 (0.5 mL) injections)), Week 8 (ZIKVwt DNA (2 (0.5 mL) injections))

             -  Subjects Total = 45 (All injections total a dose of 4 mg. ** Up to 50 total
                enrollments are permitted if additional subjects are needed to assess safety or
                immunogenicity.)

      STUDY DURATION:

      Subjects will be evaluated for safety and immune responses throughout the study for 44 weeks
      following the first vaccine administration. Durability of immune responses will be evaluated
      at two long term follow-up visits, occurring at 18 and 24 months
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: To evaluate the safety and tolerability of v ZIKV DNA vaccine administered at 4mg IM by needle and syringe.
time frame: Through 44 weeks of study participation.
measure: To evaluate the safety and tolerability of ZIKV DNA vaccine administered at 4 mg IM by Pharma jet.
time frame: Through 44 weeks of study participation.
measure: To evaluate the magnitude and the frequency of ZIKV-specific antibody response as measured by neutralization assay.
time frame: Four weeks after the first, second and third injections for each regimen.
arm group label: Group 1
arm group type: Experimental
description: ZIKV DNA vaccine administered IM via needle and syringe at a single dosage of 4 mg on Day 0, week 4 and week 8.
arm group label: Group 2
arm group type: Experimental
description: ZIKV DNA vaccine administered IM via needle and syringe as a split dose of two .5 ml injections on Day 0, week 4 and week 8.
arm group label: Group 3
arm group type: Experimental
description: ZIKV DNA vaccine administered IM via needle-free injection device, PharmaJet, as a split dose of two .5 ml injections on Day 0, week 4 and week 8.
intervention type: Biological
intervention name: VRC-ZKADNA090-00-VP
description: VRC-ZKADNA090-00-VP is an investigational ZIKV DNA vaccine that is intended to prevent Zika virus infection.
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Grace L Chen, M.D.
role: Principal Investigator
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
facility: 
country: United States
citation: Dowd KA, Ko SY, Morabito KM, Yang ES, Pelc RS, DeMaso CR, Castilho LR, Abbink P, Boyd M, Nityanandam R, Gordon DN, Gallagher JR, Chen X, Todd JP, Tsybovsky Y, Harris A, Huang YS, Higgs S, Vanlandingham DL, Andersen H, Lewis MG, De La Barrera R, Eckels KH, Jarman RG, Nason MC, Barouch DH, Roederer M, Kong WP, Mascola JR, Pierson TC, Graham BS. Rapid development of a DNA vaccine for Zika virus. Science. 2016 Oct 14;354(6309):237-240. doi: 10.1126/science.aai9137. Epub 2016 Sep 22.
PMID: 27708058
citation: Ledgerwood JE, Graham BS. DNA vaccines: a safe and efficient platform technology for responding to emerging infectious diseases. Hum Vaccin. 2009 Sep;5(9):623-6. doi: 10.4161/hv.8627. No abstract available.
PMID: 19779298
citation: Graham BS, Ledgerwood JE, Nabel GJ. Vaccine development in the twenty-first century: changing paradigms for elusive viruses. Clin Pharmacol Ther. 2009 Sep;86(3):234-6. doi: 10.1038/clpt.2009.128.
PMID: 19707212
responsible party type: Sponsor
mesh term: Zika Virus Infection