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

NCT02996461 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17002417-I-0024
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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. ...

Conditions

Prevention of Zika Infection; Zika-Specific Immune Response

Keywords

Zika Infection; Immune Response; Flavivirus; Arthropod-Borne Virus

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety and tolerability of v ZIKV DNA vaccine administered at 4mg IM by needle and syringe.

  Through 44 weeks of study participation.

• To evaluate the safety and tolerability of ZIKV DNA vaccine administered at 4 mg IM by Pharma jet.

  Through 44 weeks of study participation.

Secondary Outcomes (1)

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

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

Study Arms (3)

Group 1

EXPERIMENTAL

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

Group 2

EXPERIMENTAL

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

Group 3

EXPERIMENTAL

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

Interventions

VRC-ZKADNA090-00-VP BIOLOGICAL

VRC-ZKADNA090-00-VP is an investigational ZIKV DNA vaccine that is intended to prevent Zika virus infection.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A subject must meet all of the following criteria:
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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: 29217376 DERIVED

Study Officials

• Grace L Chen, 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: December 16, 2016
• First Posted: December 19, 2016
• Study Start: December 12, 2016
• Primary Completion: September 3, 2019
• Study Completion: September 3, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-09-03

Locations

US (1)