Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory Adults
Influenza
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, vaccine, A/H9N2, MF59, adjuvant
Eligibility 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.
Sites / Locations
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Group 1A: 3.75 mcg A/H9N2 no adjuvant
Group 2B: 7.5 mcg A/H9N2 plus MF59 adjuvant
Group 3A: 15 mcg A/H9N2 no adjuvant
Group 3B: 15 mcg A/H9N2 plus MF59 adjuvant
Group 4B: 30 mcg A/H9N2 plus MF59 adjuvant
Group 4A: 30 mcg A/H9N2 no adjuvant
Group 2A: 7.5 mcg A/H9N2 no adjuvant
Group 1B: 3.75 mcg A/H9N2 plus MF59 adjuvant
12 subjects to receive 3.75 mcg A/H9N2 with no adjuvant.
12 subjects to receive 7.5 mcg A/H9N2 plus MF59 adjuvant.
12 subjects to receive 15 mcg A/H9N2 with no adjuvant.
12 subjects to receive 15 mcg A/H9N2 plus MF59 adjuvant.
12 subjects to receive 30 mcg A/H9N2 plus MF59 adjuvant.
12 subjects to receive 30 mcg A/H9N2 with no adjuvant.
12 subjects to receive 7.5 mcg A/H9N2 with no adjuvant.
12 subjects to receive 3.75 mcg A/H9N2 plus MF59 adjuvant.