VRC 308: An Open-Label Phase I Study of the Safety and Immunogenicity of an Investigational H1 DNA Influenza Vaccine, VRC-FLUDNA057-00-VP, in Healthy Adults 18-70 Years Old
Public ClinicalTrials.gov record NCT00973895. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: * Vaccines are substances used to try to create resistance (or immunity) to a disease and to prevent an infection. Researchers are testing a new DNA vaccine designed for a new type of influenza, often referred to as swine flu. The DNA vaccine will instruct the body to make a particular kind of influenza protein that the immune system will be able to recognize. * Researchers are interested in determining if the vaccine is safe and effective in humans, and would like to study the immune system's response to the vaccine. The vaccine will not give participants influenza; however, it may not be effective in preventing them from getting influenza at a later date. Objectives: * To evaluate the safety and tolerability of the VRC-FLUDNA057-00-VP influenza vaccine as administered to healthy adults. * To evaluate antibody responses to the new influenza vaccine. Eligibility: \- Healthy adults between the ages of 18 and 70. Design: * Participants will have seven planned clinic visits during this study (enrollment day and study weeks 1, 4, 8, 9, 12, and 32). * All participants will receive three injections of the test vaccine, given as individual doses on day 0, day 28, and day 56 of the study. The vaccine will be given in the upper arm muscle. * Injections will be given using a needleless system that delivers the vaccine through the skin by using the pressure of carbon dioxide to inject the vaccine through the skin and into the muscle. Participants will remain at the National Institutes of Health (NIH) Clinical Center for at least 30 minutes after the injection to be monitored for any reaction. * Participants will be asked to keep a 7-day diary card after each injection to record their physical reactions to the vaccine. * Participants will be asked to return to the NIH Clinical Center as requested by researchers for additional blood tests and other procedures, as required by the study.
Study identification
- NCT ID
- NCT00973895
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 20 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 5, 2009
- Primary completion
- Sep 2, 2010
- Completion
- Sep 2, 2010
- Last update posted
- Jul 1, 2017
2009 – 2010
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00973895, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00973895 live on ClinicalTrials.gov.