NCT02840487

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2016

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

August 2, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2019

Completed
Last Updated

March 18, 2019

Status Verified

March 14, 2019

Enrollment Period

2.6 years

First QC Date

July 19, 2016

Last Update Submit

March 15, 2019

Conditions

Prevention of Zika InfectionZika-Specific Immune Response

Keywords

Zika InfectionFlavivirusVaccine-Mediated ProtectionImmune ResponseArthropod-Borne Virus

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety and tolerability of four vaccination regimens with ZIKV DNA vaccine (VRC-ZKADNA085-00-VP) administered IM at 4 mg.

    Through 44 weeks of study participation

Secondary Outcomes (1)

  • To evaluate the magnitude and frequency of ZIKV-specific antibodyresponse as measured by neutralization assay.

    Four weeks after the second and third injections for each regimen.

Study Arms (4)

Group 1

EXPERIMENTAL

ZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0 and Week 8.

Biological: VRC-ZKADNA085-00-VP

Group 2

EXPERIMENTAL

ZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0 and Week 12.

Biological: VRC-ZKADNA085-00-VP

Group 3

EXPERIMENTAL

ZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0, Week 4 and Week 8.

Biological: VRC-ZKADNA085-00-VP

Group 4

EXPERIMENTAL

ZIKV DNA vaccine administered IM at a dosage of 4mg, as two 0.5ml injections on Day 0,Week 4 and Week 20.

Biological: VRC-ZKADNA085-00-VP

Interventions

VRC-ZKADNA085-00-VPBIOLOGICAL

VRC-ZKADNA085-00-VP is an investigational ZIKV DNA vaccine that is intended to prevent Zika virus infection.

Group 1Group 2Group 3Group 4

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 35 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 study injection
  • Hemoglobin within institutional normal limits or accompanied by the site 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
  • +2 more criteria

You may not qualify if:

  • Breast-feeding or planning to become pregnant while participating through 12 weeks after the last study vaccination
  • 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
  • Laboratory confirmed ZIKV infection by self-report
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hope Clinic - Emory Vaccine Ctr

Decatur, Georgia, 30030, United States

Location

University of Maryland Ctr. for Vaccine Development

Baltimore, Maryland, 21201, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

  • Fauci AS, Morens DM. Zika Virus in the Americas--Yet Another Arbovirus Threat. N Engl J Med. 2016 Feb 18;374(7):601-4. doi: 10.1056/NEJMp1600297. Epub 2016 Jan 13. No abstract available.

    PMID: 26761185BACKGROUND

  • Ledgerwood JE, Pierson TC, Hubka SA, Desai N, Rucker S, Gordon IJ, Enama ME, Nelson S, Nason M, Gu W, Bundrant N, Koup RA, Bailer RT, Mascola JR, Nabel GJ, Graham BS; VRC 303 Study Team. A West Nile virus DNA vaccine utilizing a modified promoter induces neutralizing antibody in younger and older healthy adults in a phase I clinical trial. J Infect Dis. 2011 May 15;203(10):1396-404. doi: 10.1093/infdis/jir054. Epub 2011 Mar 11.

    PMID: 21398392BACKGROUND

  • Chang LJ, Dowd KA, Mendoza FH, Saunders JG, Sitar S, Plummer SH, Yamshchikov G, Sarwar UN, Hu Z, Enama ME, Bailer RT, Koup RA, Schwartz RM, Akahata W, Nabel GJ, Mascola JR, Pierson TC, Graham BS, Ledgerwood JE; VRC 311 Study Team. Safety and tolerability of chikungunya virus-like particle vaccine in healthy adults: a phase 1 dose-escalation trial. Lancet. 2014 Dec 6;384(9959):2046-52. doi: 10.1016/S0140-6736(14)61185-5. Epub 2014 Aug 14.

    PMID: 25132507BACKGROUND

  • Gaudinski MR, Houser KV, Morabito KM, Hu Z, Yamshchikov G, Rothwell RS, Berkowitz N, Mendoza F, Saunders JG, Novik L, Hendel CS, Holman LA, Gordon IJ, Cox JH, Edupuganti S, McArthur MA, Rouphael NG, Lyke KE, Cummings GE, Sitar S, Bailer RT, Foreman BM, Burgomaster K, Pelc RS, Gordon DN, DeMaso CR, Dowd KA, Laurencot C, Schwartz RM, Mascola JR, Graham BS, Pierson TC, Ledgerwood JE, Chen GL; VRC 319; VRC 320 study teams. Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials. Lancet. 2018 Feb 10;391(10120):552-562. doi: 10.1016/S0140-6736(17)33105-7. Epub 2017 Dec 5.

    PMID: 29217376DERIVED

Study Officials

  • Martin R Gaudinski, M.D.

    National Institute of Allergy and Infectious Diseases (NIAID)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 21, 2016

Study Start

August 2, 2016

Primary Completion

March 14, 2019

Study Completion

March 14, 2019

Last Updated

March 18, 2019

Record last verified: 2019-03-14

Locations

US(3)