dc.contributor.author | Chen, Grace L | |
dc.date.accessioned | 2023-01-02T23:47:46Z | |
dc.date.available | 2023-01-02T23:47:46Z | |
dc.date.issued | 2016 | |
dc.identifier.uri | https://clinicaltrials.gov/ct2/show/NCT02996461 | en_US |
dc.identifier.uri | https://hdl.handle.net/20.500.12663/3156 | |
dc.description.abstract | 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. | en_US |
dc.language | English | en_US |
dc.subject | Zika Research Project | en_US |
dc.subject | Zika Virus | en_US |
dc.subject | Immunogenicity, Vaccine | en_US |
dc.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 | en_US |
eihealth.country | Others | en_US |
eihealth.category | Epidemiology and epidemiological studies | en_US |
eihealth.type | Research protocol information | en_US |
eihealth.maincategory | Save Lives / Salvar Vidas | en_US |
dc.relation.ispartofjournal | Clinical Trials | en_US |