H5N1 Mix and Match With AS03

Completed · Phase 1 · Has a placebo group

Conditions studied: Influenza

In brief

Approximately 216, and up to 240, healthy males and non-pregnant females, 18 to 49 years old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized, double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given with the adjuvant AS03 or diluent (N=216, up to 240). All eligible subjects will receive 2 doses separated by approximately 21 days.

Key facts

Study ID

NCT01317758

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

245

Starts

2011-05-01

Expected to finish

2012-09-01

Last updated by the study team

2013-01-18

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Inclusion Criteria for study entry and Dose 1:
• Are males or non-pregnant females between the ages of 18 and 49 years, inclusive.
• Women of childbearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for >/=1 year) must agree to practice adequate contraception (that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms or diaphragms with spermicide or foam, intrauterine devices, and licensed hormonal methods) during the study for at least 30 days following the last vaccination. Adherence to contraceptive method will be captured on the appropriate case report form (CRF).
• Are in good health, as determined by vital signs (oral temp, pulse and blood pressure), medical history and complete physical examination (without genital and rectal exam) to ensure no existing chronic medical diagnoses or conditions are present.
• ESR less than 30 mm per hour.
• For women of childbearing potential, negative urine or serum pregnancy test within 24 hours prior to the first vaccination.
• Are able to understand and comply with planned study procedures.
• Provide written informed consent prior to initiation of any study procedures.
• Inclusion Criteria for Dose 2:
• Have received the first dose of study vaccine.
• For women of childbearing potential, negative urine or serum pregnancy test within 24 hours prior to the second vaccination. Adherence to contraceptive method will be captured on the appropriate case report form (CRF).

You may not qualify if…

• Exclusion Criteria for study entry and Dose 1:
• Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol-9, thimerosal and chicken protein), or allergy to squalene-based adjuvants.
• Women who are breastfeeding or plan to breastfeed at any given time from the first vaccination until 30 days after the last vaccination.
• Have long term use (defined as taken for 2 weeks or more in total at any time during the past 2 months) of high dose oral or parenteral glucocorticoids (high dose defined as prednisone >/= 20 mg total daily dose, or equivalent dose of other glucocorticoids); or highdose inhaled steroids (high dose defined as >800 mcg/day of beclomethasone dipropionate or equivalent);or systemic corticosteroids of any dose within the past 4 weeks.
• Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
• Have an active neoplastic disease or a history of any hematologic malignancy.
• Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis.
• Hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
• Receiving systemic, prescription medications for the treatment of chronic medical conditions, unless such use is on a PRN (as needed) basis only. Non-PRN use of systemic, over-the-counter medications and PRN systemic, prescription medication may be allowed if, in the opinion of the investigator, they pose no additional risk to subject safety or assessment of immunogenicity/reactogenicity. Note: Topical, nasal, and inhaled medications; vitamins; and contraceptives are also permitted.
• Received pre-medication with analgesic or antipyretic agents in the 6 hours prior to first vaccination, or planned medication with analgesic or antipyretic in the week following first vaccination. This criterion should not preclude subjects receiving such medication if the need arises. However, pre-medication is to be discouraged.
• Received immunoglobulin or other blood products (with exception of Rho D immune globulin) within the 3 months prior to the first vaccination.
• Received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to the first vaccination or plan receipt of such vaccines within 42 days following the first vaccination. This is inclusive of licensed seasonal influenza vaccines.
• Have an acute or chronic medical condition that, in the opinion of the site principal investigator or appropriate sub-investigator, would render vaccination unsafe, would interfere with the evaluation of responses or is not generally seen in "normal, healthy subjects".
• Have a history of severe reactions following previous immunization with contemporary influenza virus vaccines.
• Have an acute illness, including an oral temperature greater than or equal to 100.4 degrees F, within 3 days prior to the first vaccination.
• Pulse is less than 40 bpm or greater than 100 bpm. An ECG documenting only sinus bradycardia is required for pulses less than 50 bpm.
• Systolic blood pressure is less than 90 mm Hg or greater than 140 mm Hg.
• Diastolic blood pressure is less than 60 mm Hg or greater than 90 mmHg.
• Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to the first vaccination or expects to receive an experimental agent, other than from participation in this study, during the 13-month study period.
• Are participating or plan to participate in another clinical trial with a licensed product during the 13-month study period.
• Have any condition that would, in the opinion of the site principal investigator or appropriate sub-investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
• Participated in an influenza A/H5 vaccine study in the past in a group receiving vaccine (does not apply to documented placebo recipients) or have a history of A/H5 infection prior to enrollment.
• Have known active HIV, Hepatitis B, or Hepatitis C infection.
• Have a history of alcohol or drug abuse in the last 5 years.
• Plan to travel outside the U.S. in the time between the first vaccination and 42 days following the first vaccination.

Where it is running

• University of Maryland School of Medicine - Center for Vaccine Development - Baltimore — Baltimore, Maryland, United States
• Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center — Nashville, Tennessee, United States
• Baylor College of Medicine - Molecular Virology and Microbiology — Houston, Texas, United States
• Group Health Research Institute - Seattle — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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