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

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ClinicalTrials.gov Identifier: NCT02840487
Recruitment Status : Active, not recruiting
First Posted : July 21, 2016
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

July 19, 2016
July 21, 2016
July 6, 2018
August 2, 2016
December 28, 2018   (Final data collection date for primary outcome measure)
To evaluate the safety and tolerability of four vaccination regimens with ZIKV DNA vaccine (VRC-ZKADNA085-00-VP) administered IM at 4 mg. [ Time Frame: Through 44 weeks of study participation ]
Same as current
Complete list of historical versions of study NCT02840487 on ClinicalTrials.gov Archive Site
To evaluate the magnitude and frequency of ZIKV-specific antibodyresponse as measured by neutralization assay. [ Time Frame: Four weeks after the second and third injections for each regimen. ]
Same as current
Not Provided
Not Provided
 
Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA085-00-VP, in Healthy Adults
VRC 319: A Phase I/Ib, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of A Zika Virus DNA Vaccine, VRC-ZKADNA085-00-VP, in Healthy Adults

Background:

The Zika virus is passed to humans by infected mosquitos. It usually causes fever, rash, joint pain, and red eyes. Recently, some cases of microcephaly (abnormally small head) were reported in babies born to mothers infected with the Zika virus. Rare cases of a severe nerve weakness called Guillain-Barr(SqrRoot)(Copyright) syndrome were reported in some people with Zika virus infection. There is currently no cure for or vaccine against the infection. VRC-ZKADNA085-00-VP is a new vaccine that instructs the body to make a small amount of Zika virus protein. The body may use this to build an immune response.

Objective:

To see if VRC-ZKADNA085-00-VP is safe and causes any side effects.

Eligibility:

Healthy people ages 18 35

Design:

Participants will be screened through a separate protocol with:

  • Medical history
  • Physical exam
  • Lab and urine tests

Participants will be randomly assigned to 1 of 4 study groups. They will have about 18 clinic visits over 2 years. Most will occur in the first year, with long-term follow-up visits at months 18 and 24. Visits include a physical exam and blood and urine tests.

Participants will have vaccine injections. A high-pressure device pushes the vaccine through the skin and into the muscle of the upper arm. They will have 2-3 injections depending on their group.

Vaccine visits last 4-6 hours. Others last 1-2 hours.

Participants will keep a diary for 7 days after each injection. They will record their temperature and measure any skin changes at the injection site each day.

Participants might have extra visits and blood tests if they have health changes.

Study Design:

This is a Phase I/Ib, randomized, multicenter clinical study to evaluate the safety, tolerability, and immunogenicity of four vaccination regimens against Zika virus (ZIKV) disease. Vaccination regimens with the VRC-ZKADNA085-00-VP (ZIKV DNA) vaccine administered on Day 0 and Week 8 (Group 1); on Day 0 and Week 12 (Group 2); on Day 0, Weeks 4 and 8 (Group 3); and on Day 0, Weeks 4 and 20 (Group 4) will be tested. The primary hypothesis is that the ZIKV DNA vaccine will be safe and well tolerated in healthy adults. A secondary hypothesis is that all vaccine regimens will elicit a ZIKV-specific immune response. The primary objectives are to evaluate the safety and tolerability of the investigational vaccine regimens in healthy adults. Secondary objectives are related to the immunogenicity of the vaccination regimens.

Product Description:

The investigational VRC-ZKADNA085-00-VP vaccine was developed by the Vaccine Research Center (VRC), NIAID, and is composed of a single closed-circular DNA plasmid that encodes the wild type precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV. Vaccine is supplied in single dose vials at a concentration of 4 mg/mL. ZIKV DNA vaccine dose will be 4 mg administered as an intramuscular (IM) injection in the deltoid muscle.

Subjects:

Healthy adults 18 to 35 years of age.

Study Plan:

Subjects will be enrolled at up to 3 study sites, randomized equally into the 4 study groups, and will receive 2-3 vaccinations. The protocol requires up to 18 scheduled clinic visits and a telephone follow-up contact after each study injection. 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 through the 44 weeks on the study.

-VRC 319 Study Schema

  • Group:1; Subjects*: 20; Day 0; Week 8;
  • Group:2; Subjects*: 20; Day 0; Week 12;
  • Group:3; Subjects*: 20; Day 0; Week 4; Week 8;
  • Group:4; Subjects*: 20; Day 0; Week 4; Week 20;
  • TOTAL; Subjects*: 80

    • Up to 120 total enrollments are permitted if additional subjects are needed for assessment of safety and immune responses.

Study Duration:

Subjects will be evaluated for safety and immune responses throughout the study for 44 weeks following the first vaccine administration and for durability of immune responses at two additional long term follow-up visits at 18 and 24 months.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Prevention of Zika Infection
  • Zika-Specific Immune Response
Biological: VRC-ZKADNA085-00-VP
VRC-ZKADNA085-00-VP is an investigational ZIKV DNA vaccine that is intended to prevent Zika virus infection.
  • Experimental: Group 1
    ZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0 and Week 8.
    Intervention: Biological: VRC-ZKADNA085-00-VP
  • Experimental: Group 2
    ZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0 and Week 12.
    Intervention: Biological: VRC-ZKADNA085-00-VP
  • Experimental: Group 3
    ZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0, Week 4 and Week 8.
    Intervention: Biological: VRC-ZKADNA085-00-VP
  • Experimental: Group 4
    ZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0,Week 4 and Week 20.
    Intervention: Biological: VRC-ZKADNA085-00-VP

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
120
December 28, 2018
December 28, 2018   (Final data collection date for primary outcome measure)
  • 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
Sexes Eligible for Study: All
18 Years to 35 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02840487
160148
16-I-0148
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Not Provided
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Martin R Gaudinski, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
June 4, 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP