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NCT02206464 · ClinicalTrials.gov registry record · Phase 1
H7 Influenza Prime-Boost Regimens in Healthy Adults: Recombinant H7 DNA Plasmid Vaccine, VRC-FLUDNA071-00-VP, Administered Alone or With Monovalent Influenza Subunit Virion H7N9 Vaccine (MIV) as Prime With MIV Boost Compared to MIV Prime With MIV Boo...
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02206464 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 30 participants.
The verdict
NCT02206464, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
Background:\<TAB\> \- Flu virus that causes disease in birds can sometimes spread to people. It can cause severe illness, even death. Vaccines are used to try to create resistance to such infections. Researchers want to test a new vaccination strategy, combining two different vaccine types, the H7 DNA Vaccine (DNA vaccine) and H7N9 Monovalent Inactivated Vaccine (MIV), to see if one of two combinations offer better protection against a certain type of bird flu in humans when compared to vaccination using two doses of MIV alone. Objectives: * To see if 2 vaccines for bird flu, are safe and tolerable for humans. * To study immune responses to these vaccines. Eligibility: \- Healthy adults 18 60 years old. Design: * Participants will be screened through a separate protocol. * Participants will be randomly assigned to 1 of 3 groups. Each group will get a different combination of vaccines. * Participants will have about 8 clinic visits. Each visit takes 2 4 hours. Blood will be drawn at some visits. Urine samples may be collected. * Participants will receive vaccinations at 2 of the visits, 16 weeks apart. * The H7N9 MIV will be injected in the upper arm using a needle and syringe. The DNA vaccine will be injected in the upper arm using a device that delivers the vaccine through the skin by pressure instead of a needle. * Participants will be observed for at least 30 minutes after each vaccination. * Soon after each vaccination, participants will get 1 2 phone calls, come to clinic for evaluation, and complete a diary at home for 1 week. They will record their temperature and symptoms and look at the injection site daily. * Participants will have follow-up blood tests.
Interventions
- BIOLOGICAL A/Shanghai/02/2013 (H7N9) MIV
- BIOLOGICAL VRC-FLUDNA071-00-VP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-07-29 |
| Est. Completion | 2016-01-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02206464
The ClinicalTrials.gov registry entry for NCT02206464 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 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 2 interventions - of which A/Shanghai/02/2013 (H7N9) MIV is the first listed.
NCT02206464 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02206464 about?
NCT02206464 is a clinical study titled "H7 Influenza Prime-Boost Regimens in Healthy Adults: Recombinant H7 DNA Plasmid Vaccine, VRC-FLUDNA071-00-VP, Administered Alone or With Monovalent Influenza Subunit Virion H7N9 Vaccine (MIV) as Prime With MIV Boost Compared to MIV Prime With MIV Boo...". Background:\<TAB\> \- Flu virus that causes disease in birds can sometimes spread to people. It can cause severe illness, even death. Vaccines are used to try to create resistance to such infections. Researchers want to test a new vaccination strategy, combining two different vaccine types, the H7 ...
What is the current status of trial NCT02206464?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2014-07-29. Estimated completion is 2016-01-07.
What interventions are being tested in trial NCT02206464?
The interventions under investigation include: A/Shanghai/02/2013 (H7N9) MIV (BIOLOGICAL), VRC-FLUDNA071-00-VP (BIOLOGICAL).
Who is sponsoring clinical trial NCT02206464?
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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