An Open-Label, Randomized Phase I Study in Healthy Adults of the Safety and Immunogenicity of Prime-Boost Intervals With Monovalent Influenza Subunit Virion (H5N1) Vaccine, A/Indonesia/05/2005 (Sanofi Pasteur, Inc.) Administered Alone or Following Re...

Completed · Phase 1

Conditions studied: Influenza A Virus, H5N1 Subtype

In brief

Background: \- New vaccines against avian influenza, also known as "bird flu," are being developed and require testing to determine if they are safe and effective and whether they have any side effects. Researchers are interested in testing two experimental avian influenza vaccines to see whether they are safe, if there are any side effects from the vaccines, and how the body's immune response differs in response to different vaccination schedules. One vaccine is an inactivated vaccine (made with killed or weakened influenza) and one is a DNA vaccine that allows the body to use vaccine to make an immune system response to a specific part of an avian influenza protein. Objectives: * To determine the safety and potential side effects of two experimental vaccines against avian influenza. * To evaluate whether the time between the two experimental vaccine injections affects the immune response to the vaccine. Eligibility: \- Healthy individuals between 18 and 60 years of age. Design: * Participants will be randomly divided (by chance) into six groups to receive two injections of vaccine at different intervals. One group will receive only the inactivated vaccine, while the other groups will receive the DNA vaccine followed by the inactivated vaccine at different intervals (e.g., 4 weeks, 8 weeks, 12 weeks, 16 weeks or 24 weeks later). * Participants will remain at the clinical center for at least 30 minutes after each vaccination. A few days after each injection, participants will contact staff by telephone or have a clinic visit. Participants will also be asked to complete a diary card at home for 5 days to keep track of temperature changes, injection site skin changes, and other effects. * Four weeks after the first injection, participants will return for a clinic visit and to provide blood samples for testing. * Two weeks after the second injection, participants will return for a clinic visit and provide blood samples (collected through apheresis) to provide information on immune response to the vaccine.

Key facts

Study ID: NCT01086657
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 64
Starts: 2010-02-25
Expected to finish: 2011-12-12
Last updated by the study team: 2017-07-02

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not 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 first 28 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 exception 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. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days (2 weeks) of initial study vaccine administration
Current anti-TB prophylaxis or therapy
Previous H5 avian influenza investigational vaccine.
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 the investigator.
Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids.
Diabetes mellitus (type I or II), with the exception of gestational diabetes.
Thyroid disease that is not well controlled.
Idiopathic urticaria within the past 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

Full record on ClinicalTrials.gov

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