Status:
COMPLETED
Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without Adjuvant System 03 (AS03)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Emory University
Conditions:
Influenza A Virus, H5N1 Subtype
Eligibility:
All Genders
21-45 years
Phase:
PHASE2
Brief Summary
This study will compare the different immune responses to Influenza A (H5N1) Virus Monovalent Vaccine with and without the AS03 adjuvant. The Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adju...
Detailed Description
The influenza virus (a germ) causes influenza or "flu." The flu is an infection of the breathing tubes and the lungs. In recent years, flu viruses that at first only infected birds have begun to infec...
Eligibility Criteria
Inclusion
- Individuals in good health (as determined by vital signs, medical history, physical examination and laboratory tests);
- Able to understand and give informed consent;
- Women of childbearing potential must agree to practice adequate contraception 1 month prior to study entry and until day 100 of the study.
Exclusion
- Personal or family history of sleeping disorders including any of the following: Narcolepsy with or without cataplexy; Idiopathic Hypersomnia or excessive daytime sleepiness of unknown origin; Sleep paralysis; Sleep related hallucinations (hypnagogic or hypnopompic hallucinations);
- Human leukocyte antigen (HLA)-DQB1\*06:02 positivity (or DQB1\*06 positivity if high resolution HLA testing cannot be performed);
- An abnormal erythrocyte sedimentation rate at baseline;
- Receipt of blood products 3 months prior to study entry and until day 100 of the study;
- Volunteers who donated blood 56 days before screening and have plans to donate on or before day 100 of the study;
- Hemoglobin value of less than 12 mg/dL for females and less than 13 mg/dL for males;
- A positive result in the Narcolepsy Mini Screen questionnaire;
- A score of ≥11 on the Epworth sleepiness scale questionnaire;
- Receipt of any experimental agents within 6 weeks prior to first vaccination and until the completion of the study;
- Receipt of any licensed live vaccine within 4 weeks or any licensed inactivated vaccine within 2 weeks prior to the first study vaccination or planned receipt of any vaccine within 42 days after study entry;
- Receipt of a H5 vaccine or AS03-adjuvanted vaccine at any time in the past prior to current study or have a history of A/H5N1 infection;
- Influenza-like illness (ILI) or documented influenza infection during the 2013-2014 influenza season. \[Not excluded from the study, volunteers with prior upper respiratory infections other than ILI\];
- Chronic medical problems including (but not limited to) insulin dependent diabetes, severe heart disease, severe lung disease, severe liver disease, severe kidney disease, autoimmune disease, severe gastrointestinal disease;
- Alcohol or drug abuse and psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data;
- Impaired immune function or chronic infections including (but not limited to) HIV, hepatitis B or C; organ transplant; active cancer or any history of hematologic cancer; receipt of chemotherapy, radiation therapy (past 36 months) or any other potentially immunosuppressive therapy \[i.e. Systemic steroids at any dose and intra-articular administration of steroids in the past 3 months; (Nasal and topical steroids are allowed)\], congenital immunodeficiency, anatomical or functional asplenia;
- Heart rate less than 40 bpm or greater than 100 bpm. Systolic blood pressure is less than 90 mm Hg or equal or greater than 160 mm Hg. Diastolic blood pressure is less than 60 mm Hg or equal or greater than 100 mg Hg;
- Pregnancy or postpartum (less than 1 year after delivery) or breast feeding;
- Severe reactions to prior vaccination with influenza virus vaccines, including anaphylaxis;
- History of Guillain-Barré syndrome;
- A previous sudden life-threatening allergic reaction to any ingredient of Influenza A (H5N1) Virus Monovalent Vaccine with or without AS03 adjuvant or to any of the substances that may be present in trace amounts such as thiomersal, egg residues including ovalbumin as well as residual amounts of sodium deoxycholate detergent, formaldehyde and sucrose;
- Volunteers with any acute illness, including any fever (\> 100.4 F \[\> 38.0 C\], regardless of the route) within 3 days prior to study entry;
- Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01910519
Start Date
July 1 2013
End Date
November 1 2015
Last Update
February 12 2019
Active Locations (1)
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1
The Hope Clinic - Emory Vaccine Center
Decatur, Georgia, United States, 30030