H7N9 Mix and Match With AS03 and MF59 in Healthy Adults
NCT ID: NCT01942265
Last Updated: 2017-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
980 participants
INTERVENTIONAL
2013-09-30
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group 4
100 subjects receive 15mcg sanofi A/H7N9 antigen plus GSK AS03 adjuvant on Day 0 and 15mcg sanofi A/H7N9 antigen on Day 21
AS03
Subjects will receive two doses of the A/H7N9 vaccine with or without AS03 delivered intramuscularly 21 days apart.
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Subjects will receive two doses of the A/H7N9 vaccine with or without an adjuvant delivered intramuscularly approximately 21 days apart.
Group 3
100 subjects receive 15mcg sanofi A/H7N9 antigen plus GSK AS03 adjuvant on Day 0 and 21
AS03
Subjects will receive two doses of the A/H7N9 vaccine with or without AS03 delivered intramuscularly 21 days apart.
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Subjects will receive two doses of the A/H7N9 vaccine with or without an adjuvant delivered intramuscularly approximately 21 days apart.
Group 1
100 subjects receive 3.75mcg sanofi A/H7N9 antigen plus GSK AS03 adjuvant on Day 0 and 21
AS03
Subjects will receive two doses of the A/H7N9 vaccine with or without AS03 delivered intramuscularly 21 days apart.
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Subjects will receive two doses of the A/H7N9 vaccine with or without an adjuvant delivered intramuscularly approximately 21 days apart.
Group 2
100 subjects receive 7.5mcg sanofi A/H7N9 antigen plus GSK AS03 adjuvant on Day 0 and 21
AS03
Subjects will receive two doses of the A/H7N9 vaccine with or without AS03 delivered intramuscularly 21 days apart.
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Subjects will receive two doses of the A/H7N9 vaccine with or without an adjuvant delivered intramuscularly approximately 21 days apart.
Group 5
100 subjects receive 15mcg sanofi A/H7N9 antigen on Day 0 and 15mcg sanofi A/H7N9 antigen plus GSK AS03 adjuvant on Day 21
AS03
Subjects will receive two doses of the A/H7N9 vaccine with or without AS03 delivered intramuscularly 21 days apart.
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Subjects will receive two doses of the A/H7N9 vaccine with or without an adjuvant delivered intramuscularly approximately 21 days apart.
Group 9
100 subjects receive 15mcg sanofi A/H7N9 antigen on Day 0 and 21
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Subjects will receive two doses of the A/H7N9 vaccine with or without an adjuvant delivered intramuscularly approximately 21 days apart.
Group 8
100 subjects receive 15mcg sanofi A/H7N9 antigen plus NVD MF59 adjuvant on Day 0 and 21
MF59
Subjects will receive two doses of the A/H7N9 vaccine with or without MF59 delivered intramuscularly 21 days apart.
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Subjects will receive two doses of the A/H7N9 vaccine with or without an adjuvant delivered intramuscularly approximately 21 days apart.
Group 7
100 subjects receive 15mcg sanofi A/H7N9 antigen plus NVD MF59 adjuvant on Day 0 and 15mcg sanofi A/H7N9 antigen plus GSK AS03 adjuvant on Day 21
AS03
Subjects will receive two doses of the A/H7N9 vaccine with or without AS03 delivered intramuscularly 21 days apart.
MF59
Subjects will receive two doses of the A/H7N9 vaccine with or without MF59 delivered intramuscularly 21 days apart.
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Subjects will receive two doses of the A/H7N9 vaccine with or without an adjuvant delivered intramuscularly approximately 21 days apart.
Group 6
100 subjects receive 15mcg sanofi A/H7N9 antigen plus GSK AS03 adjuvant on Day 0 and 15mcg sanofi A/H7N9 antigen plus NVD MF59 adjuvant on Day 21
AS03
Subjects will receive two doses of the A/H7N9 vaccine with or without AS03 delivered intramuscularly 21 days apart.
MF59
Subjects will receive two doses of the A/H7N9 vaccine with or without MF59 delivered intramuscularly 21 days apart.
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Subjects will receive two doses of the A/H7N9 vaccine with or without an adjuvant delivered intramuscularly approximately 21 days apart.
Group 10
100 subjects receive 45 mcg sanofi A/H7N9 antigen on Day 0 and 21
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Subjects will receive two doses of the A/H7N9 vaccine with or without an adjuvant delivered intramuscularly approximately 21 days apart.
Interventions
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AS03
Subjects will receive two doses of the A/H7N9 vaccine with or without AS03 delivered intramuscularly 21 days apart.
MF59
Subjects will receive two doses of the A/H7N9 vaccine with or without MF59 delivered intramuscularly 21 days apart.
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
Subjects will receive two doses of the A/H7N9 vaccine with or without an adjuvant delivered intramuscularly approximately 21 days apart.
Eligibility Criteria
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Inclusion Criteria
* Are able to understand and comply with planned study procedures and be available for all study visits.
* Are males or non-pregnant females, 19 to 64 years old, inclusive.
Exclusion Criteria
* Pulse is 50 to 115 bpm, inclusive.
* Systolic blood pressure is 85 to 150 mm Hg, inclusive.
* Diastolic blood pressure is 55 to 95 mmHg, inclusive.
* Erythrocyte sedimentation rate (ESR) is less than 30 mm per hour.
* Alanine aminotransferase (ALT) is less than 44 IU/L for females or is less than 61 IU/L for males.
* Creatinine is less than 1.11 mg/dL for females or is less than 1.38 mg/dL for males.
* White blood cells (WBC) are greater than 3.9 x10\^3/UL and less than 10.6 x10\^3/UL.
* Hemoglobin is greater than 11.4 g/dL for females or is greater than 12.4 g/dL for males.
* Platelets are greater than 139 x10\^3/UL and less than 416 x10\^3/UL.
* Total bilirubin is less than 1.3 mg/dL.
* Female subjects of childbearing potential who are not surgically sterile via tubal sterilization, bilateral oophorectomy, or hysterectomy or who are not postmenopausal for \>/= 1 year must agree to practice highly effective contraception that may include, but is not limited to, abstinence from intercourse with a male partner, monogamous relationship with a vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, and licensed hormonal methods with use of a highly effective method of contraception for a minimum of 30 days prior to study product exposure and agree to practice highly effective contraception for the duration of study product exposure, including 2 months (defined as 60 days) after the last study vaccination. A highly effective method of contraception is defined as one which results in a low failure rate (i.e., less than 1 percent per year) when used consistently and correctly. Method of contraception will be captured on the appropriate data collection form.
* Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.
* Have an acute illness within 72 hours prior to study vaccination.
* Have any condition that, in the opinion of the site principal investigator or appropriate sub-investigator, would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or confound the interpretation of the results.
* Have an acute or chronic medical condition that, in the opinion of the site principal investigator or appropriate sub-investigator, would render vaccination unsafe, or would interfere with the evaluation of responses.
* Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
* Have known active neoplastic disease or a history of any hematologic malignancy.
* Have known HIV, hepatitis B, or hepatitis C infection.
* Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccine.
* Have a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines.
* Have a personal or family history of narcolepsy with or without cataplexy.
* Have a history of Guillain-Barré Syndrome.
* Have a history of neuralgia, paresthesia, neuritis, convulsions, or encephalomyelitis within 90 days prior to study vaccination.
* Have a history of autoimmune disease, including but not limited to neuroinflammatory diseases, vasculitis, clotting disorders, dermatitis, arthritis, thyroiditis, or muscle, liver or kidney disease.
* Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
* Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
* Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination.
* Have taken oral or parenteral corticosteroids of any dose within 30 days prior to study vaccination.
* Have taken high-dose inhaled corticosteroids within 30 days prior to study vaccination. High-dose defined as \>800mcg/day of beclomethasone dipropionate CFC or equivalent.
* Received any licensed live vaccine within 30 days or any licensed inactivated vaccine within 14 days prior to the first study vaccination or planned receipt of any vaccine from the first study vaccination through the follow-up visit at approximately 21 days after the last study vaccination. This is inclusive of licensed seasonal influenza vaccines.
* Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin) within 90 days prior to study vaccination.
* Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 30 days prior to the first study 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 an interventional agent (licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) during the 13-month study period.
* Prior participation in a clinical trial of influenza A/H7 vaccine and assigned to a group receiving influenza A/H7 vaccine (does not apply to documented placebo recipients) or have a history of A/H7 actual or potential exposure or infection prior to the first study vaccination.
* Plan to travel outside the U.S. (continental U.S., Hawaii and Alaska) in the time between the first study vaccination and 42 days after the first study vaccination.
* Female subjects who are breastfeeding or plan to breastfeed at any given time from the first study vaccination until 30 days after their last study vaccination.
* Blood donation within 30 days prior to enrollment and within 30 days after the last blood draw (only for a subset of healthy adult subjects - all volunteers, 19-64 years old, enrolled at the Vanderbilt VTEU site, who consent to blood donation for the immunology exploratory assays).
19 Years
64 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Locations
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University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, United States
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, United States
Vanderbilt University Medical Center - Infectious Diseases
Nashville, Tennessee, United States
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, United States
Group Health Research Institute - Seattle - Vaccines and Infectious Diseases
Seattle, Washington, United States
Countries
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References
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Jackson LA, Campbell JD, Frey SE, Edwards KM, Keitel WA, Kotloff KL, Berry AA, Graham I, Atmar RL, Creech CB, Thomsen IP, Patel SM, Gutierrez AF, Anderson EL, El Sahly HM, Hill H, Noah DL, Bellamy AR. Effect of Varying Doses of a Monovalent H7N9 Influenza Vaccine With and Without AS03 and MF59 Adjuvants on Immune Response: A Randomized Clinical Trial. JAMA. 2015 Jul 21;314(3):237-46. doi: 10.1001/jama.2015.7916.
Other Identifiers
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HHSN272200800004C
Identifier Type: -
Identifier Source: secondary_id
13-0033
Identifier Type: -
Identifier Source: org_study_id
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