VRC 308: An Open-Label Phase I Study of the Safety and Immunogenicity of an Investigational H1 DN⌠(NCT00973895) | Clinical Trial Compass
CompletedPhase 1
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
United States20 participantsStarted 2009-08-06
Plain-language summary
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.
Who can participate
Age range18 Years â 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
â. 18 to 70 years old.
â. Available for clinical follow-up through Week 32.
â. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
â. Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly.
â. Able and willing to complete the informed consent process.
â. Willing to donate blood for sample storage to be used for future research.
â. No evidence of previously undiagnosed clinically significant chronic diseases.
â. Physical examination and laboratory results without clinically significant findings, no fever (greater than or equal to 100.4 degree F) in the 72 hours prior to enrollment, and a Body Mass Index (BMI) greater than or equal to 18 and \< 42 within the 56 days prior to enrollment.
Exclusion criteria
â. Breast-feeding or planning to become pregnant during the first 32 weeks after enrollment in the study.
What they're measuring
1
Safety (local and systemic reactogenicity, lab tests, AEs)
Timeframe: 32 weeks
Trial details
NCT IDNCT00973895
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
â. Systemic immunosuppressive medications or cytotoxic medications within the 12 weeks prior to enrollment. \[With the exceptions that a short course (duration of 10 days or less or a single injection) of corticosteroids for a self-limited condition at least 2 weeks prior to enrollment in this study will not exclude study participation.\]
â. Blood products within 112 days (16 weeks) prior to HIV screening
â. Immunoglobulin within 56 days (8 weeks) prior to HIV screening
â. Live attenuated vaccines within 28 days (4 weeks) prior to initial study vaccine administration
â. Investigational research agents within 28 days (4 weeks) prior to initial study vaccine administration
â. Medically indicated subunit or killed vaccines (e.g., pneumococcal, or allergy treatment with antigen injections) within 14 days (2 weeks) of initial study vaccine administration