A/H5N1in Adult - Aventis

Completed · Phase 1/Phase 2

Conditions studied: Influenza

In brief

The purpose of this research study is to compare how the body reacts to different strengths of the new H5N1 flu vaccine. The study will also look at how antibodies are made after a subject receives the H5N1 flu vaccine. The vaccine will be given as a shot in the arm. Participants will be randomly assigned to receive 1 of 4 different dosages of the vaccine or a placebo (dummy) dose of the vaccine. Study procedures will include a physical exam, a urine pregnancy test for women, and blood samples. Participants will be asked to complete a diary to record temperatures, medications taken, and side effects from the vaccine. Volunteers will be involved with study procedures for approximately 7 months. The study will enroll about 450-470 healthy participants, ages 18-64.

Key facts

Study ID

NCT00115986

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

452

Starts

2005-03-01

Expected to finish

2006-02-01

Last updated by the study team

2013-08-23

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must meet all of the following inclusion criteria to participate in this study: 1. Male or nonpregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 64 years, inclusive. 2. Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (ie, barrier method, abstinence, and licensed hormonal methods) for the entire study period. 3. Is in good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history and a targeted physical examination based on medical history. 4. In Stage I subjects, should have normal laboratory values of Hgb, WBC, Plt, ALT, and creatinine prior to the first immunization. 5. Able to understand and comply with planned study procedures. 6. Provides informed consent prior to any study procedures and is available for all study visits.

You may not qualify if…

• Subjects who meet any of the following exclusion criteria at baseline will be excluded from study participation: 1. Has a known allergy to eggs or other components of the vaccine. 2. Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential) or women who are breastfeeding. 3. Is undergoing immunosuppression as a result of an underlying illness or treatment. 4. Has an active neoplastic disease or a history of any hematologic malignancy. 5. Is using oral or parenteral steroids, high-dose inhaled steroids (>800 µg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs. 6. Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study. 7. Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study. 8. Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients). 9. Has a history of severe reactions following immunization with contemporary influenza virus vaccines. 10. Has an acute illness, including an oral temperature greater than 100.4ºF, within 1 week of vaccination. 11. Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during the 7-month study period. 12. Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Where it is running

• University of Maryland Baltimore — Baltimore, Maryland, United States
• University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases — Rochester, New York, United States
• UCLA Center For Vaccine Research — Torrance, California, United States

Full record on ClinicalTrials.gov

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