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

Completed · Phase 1

Conditions studied: Influenza A Virus, H1N1 Subtype, Novel Swine-Origin

In brief

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.

Key facts

Study ID

NCT00973895

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

20

Starts

2009-08-06

Expected to finish

2010-09-03

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Women Specific:
• <!-- -->
• Breast-feeding or planning to become pregnant during the first 32 weeks after enrollment in the study.
• Subject has received any of the following substances:
• 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.]
• Blood products within 112 days (16 weeks) prior to HIV screening
• Immunoglobulin within 56 days (8 weeks) prior to HIV screening
• Live attenuated vaccines within 28 days (4 weeks) prior to initial study vaccine administration
• Investigational research agents within 28 days (4 weeks) prior to initial study vaccine administration
• 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
• Current anti-TB prophylaxis or therapy
• Subject has a history of any of the following clinically significant conditions:
• Serious reactions to vaccines that preclude receipt of study vaccinations as determined by investigator.
• Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
• Asthma that is severe, unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral, intravenous, or high dose inhaled corticosteroids.
• Diabetes mellitus type I.
• Thyroid disease that is not well-controlled.
• Generalized idiopathic urticaria within the last 1 year.
• Hypertension that is not well controlled by medication or is more than 145/95 at enrollment.
• 16 Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
• Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study.
• Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years.
• Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.
• Guillain-Barr Syndrome.
• Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within 5 years prior to enrollment, a history of suicide plan or attempt.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.