VRC 309: A Multi-Center, Open-Label, Randomized Phase I Study of an Investigational Influenza DNA Vaccine Followed by 2009/2010 Seasonal Influenza Trivalent Inactivated Vaccine (TIV) Compared to Two Injections of TIV in Adults 45-70 Years

Completed · Phase 1

Conditions studied: Influenza, Human

In brief

Background: * Vaccines are substances used to try to create resistance or immunity to a disease and to prevent an infection. Investigators are looking into improved ways to give and test the results of different kinds of vaccines. * Researchers are interested in comparing the results of an experimental DNA vaccine for the prevention of seasonal influenza against a standard FDA-approved vaccine for the prevention of seasonal influenza. The experimental DNA vaccine is not yet approved by the FDA for preventing the flu. Objectives: \- To test the safety and immune response of an experimental DNA vaccine for seasonal influenza, compared to the standard vaccine for seasonal influenza. Eligibility: \- Healthy individuals between ages 45 and 70 who have not yet received the seasonal influenza vaccine. Design: * Participants will have six planned clinic visits (Weeks 0, 1, 3, 4, 6, and 27) and two telephone follow-up contacts (within 2 days after each injection) during this study. * Participants will be divided into two groups: one group will receive two standard (TIV) flu vaccine injections given using a needle and syringe, while the other will receive the DNA flu vaccine using a needleless injection system followed by the TIV vaccine. * The vaccine injections for both groups will be given approximately 3 weeks apart, * Clinic staff will observe participants for at least 30 minutes after each vaccination. One to two days after each injection, participants must telephone the clinic staff, and for 7 days after the vaccination participants will keep a diary card to report on possible side effects. * During study visits, blood samples will be collected for research purposes to test for responses to vaccine.

Key facts

Study ID

NCT00995982

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

60

Starts

2009-10-08

Expected to finish

2010-09-03

Last updated by the study team

2017-07-02

Who can join

Age: 45 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• A subject will be excluded if one or more of the following conditions apply:
• Women Specific:
• Breast-feeding or planning to become pregnant during the 27 weeks after enrollment in the study.
• Subject has received any of the following substances:
• Seasonal influenza TIV within the 12 weeks prior to enrollment.
• 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:
• Contraindication to receiving an FDA approved current seasonal influenza vaccination (e.g., egg allergy).
• 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.
• 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.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• Clinical Alliance for Research and Education — Annandale, Virginia, United States

Full record on ClinicalTrials.gov

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