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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

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ClinicalTrials.gov Identifier: NCT02996461
Recruitment Status : Active, not recruiting
First Posted : December 19, 2016
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Prevention of Zika Infection Zika-Specific Immune Response Biological: VRC-ZKADNA090-00-VP Phase 1

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : December 16, 2016
Estimated Primary Completion Date : December 28, 2018
Estimated Study Completion Date : December 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Zika Virus
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Group 1
ZIKV DNA vaccine administered IM via needle and syringe at a single dosage of 4 mg on Day 0, week 4 and week 8.
Biological: VRC-ZKADNA090-00-VP
VRC-ZKADNA090-00-VP is an investigational ZIKV DNA vaccine that is intended to prevent Zika virus infection.
Experimental: Group 2
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.
Biological: VRC-ZKADNA090-00-VP
VRC-ZKADNA090-00-VP is an investigational ZIKV DNA vaccine that is intended to prevent Zika virus infection.
Experimental: Group 3
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.
Biological: VRC-ZKADNA090-00-VP
VRC-ZKADNA090-00-VP is an investigational ZIKV DNA vaccine that is intended to prevent Zika virus infection.


Outcome Measures

Primary Outcome Measures :
  1. 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. ]
  2. 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. ]

Secondary Outcome Measures :
  1. 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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996461


Locations
United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Grace L Chen, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02996461     History of Changes
Other Study ID Numbers: 170024
17-I-0024
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 20, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Zika Infection
Immune Response
Flavivirus
Arthropod-Borne Virus

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs