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

Completed · Phase 1

Conditions studied: Prevention of Zika Infection, Zika-Specific Immune Response

In brief

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. ...

Key facts

Study ID

NCT02996461

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

45

Starts

2016-12-12

Expected to finish

2019-09-03

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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