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NCT01806909 · ClinicalTrials.gov registry record · Phase 1
Intranasal AD4-H5-VTN as an Adenovirus Vaccine
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT01806909 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 51 participants.
The verdict
NCT01806909, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
Background: * Adenoviruses are viruses that typically cause symptoms of a cold or eye infection. These viruses are being tested as part of a possible new vaccine. Researchers hope that the adenovirus will help carry the vaccine into the body and cause an immune response. An immune response is the body s release of cells and substances that protect the body from infection. If an adenovirus vaccine can be developed, it might be used as part of a vaccine for malaria or other serious illnesses. Researchers want to test the adenovirus vaccine as a nasal spray in healthy volunteers. The vaccine is called AD4-H5-VTN. * Because the vaccine contains a live adenovirus, there is a possibility that participants can infect other people. Therefore, participants' intimate contacts must join this study. An intimate contact is someone who the participant will kiss on the mouth or have sexual intercourse with during the period of this study. Objectives: * To study the immune response of the AD4-H5-VTN vaccine in healthy volunteers. * To see if the adenovirus in the AD4-H5-VTN vaccine is contagious or spreads to others. Eligibility: * Healthy volunteers between 18 and 49 years of age. * Intimate contacts of healthy volunteers between 18 and 65 years of age. * Participants must not have evidence of previous exposure to adenovirus type 4. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * Participants who will receive the vaccine must be willing to be hospitalized for between 5 and 7 days. They will come to the National Institutes of Health for follow-up visits weekly for the first month, after 8 weeks, in 6 months, and possibly 1 year. They must also avoid all vaccines (including seasonal flu vaccine) and allergy shots for 30 days before and after having the study vaccine. * Participants will enter the hospital for the vaccine study visit. They will receive the vaccine as a nasal spray. Because the vacci
Interventions
- BIOLOGICAL Ad4-H5-Vtn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2013-03-06 |
| Est. Completion | 2019-04-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01806909
The ClinicalTrials.gov registry entry for NCT01806909 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ad4-H5-Vtn is the first listed.
NCT01806909 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01806909 about?
NCT01806909 is a clinical study titled "Intranasal AD4-H5-VTN as an Adenovirus Vaccine". Background: * Adenoviruses are viruses that typically cause symptoms of a cold or eye infection. These viruses are being tested as part of a possible new vaccine. Researchers hope that the adenovirus will help carry the vaccine into the body and cause an immune response. An immune response is the b...
What is the current status of trial NCT01806909?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2013-03-06. Estimated completion is 2019-04-22.
What interventions are being tested in trial NCT01806909?
The interventions under investigation include: Ad4-H5-Vtn (BIOLOGICAL).
Who is sponsoring clinical trial NCT01806909?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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