Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory Adults

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the body's reactions and immune responses after receiving different strengths of a H9N2 influenza virus vaccine with and without an adjuvant given into the arm muscle. Study participants will include up to 96 healthy adults, ages 18-34. The 4 dosages of the experimental H9N2 vaccine to be tested in this study are the following: 3.75, 7.5, 15, and 30-mcg (with and without MF59 adjuvant). Participants will be vaccinated on Days 0 and 28. Participants will record any vaccine side effects in a diary for 7 days following each vaccination. Participants will return to the clinic on days 2 and 7 after vaccination. Blood samples will be collected 7 days following each vaccination. Serum and nasal wash specimens will be collected before each vaccination and 4 weeks after injections (0, 4, and 8 weeks). Participants will be involved in study related procedures for up to 8 months.

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

Details

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

Criteria

Inclusion Criteria:

• Ambulatory, healthy males and non-pregnant female adults 18-34 years of age.

• Able to give informed consent and available for all study visits.

• Able to understand and comply with planned study procedures.

• Women capable of bearing children must utilize an acceptable means of birth control (abstinence, oral contraceptives ("the pill"), intrauterine devices (IUDs), contraceptive implants under the skin, or contraceptive injections, or condoms with foam).

• On no concomitant medications except contraceptive medications.

• Normal screening laboratory values.

Exclusion Criteria:

• Known allergy to eggs or other components of vaccine.

• Prior receipt of an influenza A/H9N2 vaccine.

• Abnormal screening laboratory values (laboratory values must be within normal limits).

• Pregnancy, desire to become pregnant in the next 3 months, or lactation.

• Immunosuppression as a result of underlying illness or treatment.

• Use of oral or parenteral steroids, high-dose inhaled steroids (>800 mcg per day of beclomethasone dipropionate or equivalent), other immunosuppressive or cytotoxic drugs.

• Active neoplastic disease or history of any hematologic malignancy.

• Acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses (including but not limited to the following: known chronic liver disease, significant renal disease, unstable or progressive neurologic disorder, diabetes mellitus, transplant recipient).

• Use of experimental vaccines or medications within the month prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products during the 1 month period after each inoculation with study vaccine.

• Receipt of immunoglobulin or other blood product within 3 months prior to enrollment.

• Receipt of other licensed vaccines within the preceding 2 weeks (inactivated vaccines) or 4 weeks (live vaccines).

• History of a severe reaction following vaccination with a contemporary influenza vaccine.

• Subject is enrolled in another clinical trial.

• Study personnel (those persons identified on study personnel logs).

• Any condition that in the opinion of the investigator would interfere with the interpretation or evaluation of the vaccine.