H5 Adult - Chiron Study of Bird Flu Vaccine

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is will gather critical information on the safety, tolerability, and the immunogenicity (capability of causing an immune response) of A/H5N1 (Bird flu) virus vaccine in healthy adults. Up to 400 healthy adults, aged 18 to 64, will participate. Each subject will participate for about 7 months and will be randomly placed in one of several different study groups receiving a different dose of vaccine or placebo. All subjects will receive two injections of their assigned study product, about 28 days apart, in the muscle. Subjects will keep a journal of their temperature and any adverse effects between study visits. A small amount of blood will also be drawn before the first injection, 7 days after each injection, 1 month after the first injection, and 1 and 6 months after the second injection.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Aluminum Hydroxide; MF59 oil emulsion; Vaccines

Criteria

Inclusion Criteria:

• Healthy 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.

• Women of childbearing potential (not surgically sterile or post menopausal for greater than or equal to one year) must agree to practice adequate contraception (i.e., barrier method, abstinence, and licensed hormonal methods) for the entire study period.

• 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.

• Subjects should have normal safety laboratory values (Hgb, WBC, Plt, ALT, and creatinine) prior to the first immunization.

• Able to understand and comply with planned study procedures.

• Provides written informed consent prior to initiation of any study procedures.

Exclusion Criteria:

• Has a known allergy to eggs or other components of the vaccine or latex.

• Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential) or women who are breastfeeding.

• Is undergoing immunosuppression as a result of an underlying illness or treatment.

• Has an active neoplastic disease or a history of any hematologic malignancy.

• Is using oral or parenteral steroids, high-dose inhaled steroids (greater than 800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs (nasal and topical steroids are allowed).

• Has a history of receiving immunoglobulin or other blood products within the 3 months prior to vaccination in this study.

• Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to vaccination in this study.

• 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).

• Has a history of severe reactions following immunization with contemporary influenza virus vaccines.

• Has an acute illness, including an oral temperature greater than 100.4 degrees F, within 1 week of vaccination.

• Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study, or expects to receive an experimental agent during the 7-month study period.

• 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.

• Participated in H5 vaccine study in the past.

• Known current HIV, hepatitis B (HBsAg) or hepatitis C infection.

• History of alcohol or drug abuse in the last 5 years.

• Planned travel outside the US between vaccination and the second study visit.

• History of Guillain-Barre.