Phase 1 Study of a H5N1 Influenza Vaccine (Reverse Genetic Reassortant)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 422

Inclusion Criteria

Subjects who

Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
Are clinically healthy, as determined by the Investigator's clinical judgment through collection of medical history and performance of a physical examination
Are physically and mentally capable of participating in the study
Are willing to refrain from blood donation for the duration of Part A of the study (until Day 42 [= 21 days after the second vaccination])
Agree to keep a daily record of symptoms for the duration of the study
If female and capable of bearing children - have a negative urine pregnancy test result within 24 hours of the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria

Subjects will be excluded from participation in this study if they:

Have a history of exposure to H5N1 influenza virus or a history of vaccination with an H5N1 influenza vaccine
Are at potential occupational risk of contracting H5N1 influenza infection (e.g., poultry workers)
Suffer from or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, metabolic or renal disorder
Have a Body Mass Index > 35
Have hypertension at screening that is graded as greater than Stage 1 (defined as a systolic pressure > 159 or diastolic pressure > 99) while seated and at rest (measurement shall be repeated twice before subject is excluded)
Have clinically significant abnormal clinical laboratory values at screening as determined by the Investigator
Have clinically significant electrocardiographic abnormalities at screening
Test positive for HIV, HBcAb or HCV
Suffer from any kind of immunodeficiency
Suffer from a disease or were undergoing a form of treatment within 30 days of study entry or are currently undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs
Have a history of severe allergic reactions (e.g. clinically severe urticaria, allergic rhinitis, asthma) or anaphylaxis (a medical emergency caused by an acute hypersensitivity reaction involving several organ systems including, but not limited to, cardio-respiratory signs with mucosal and/or skin changes (e.g. angioedema, etc) that presents as or rapidly progresses to a severe life-threatening reaction.
Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
Have received any blood products (e.g. a blood transfusion or immunoglobulins within 90 days of vaccination in this study
Have donated one or more units of blood (approximately 450 mL) or plasma within 30 days of vaccination in this study
Have received any live vaccine within 4 weeks or an inactivated vaccine or subunit vaccine within 2 weeks prior to vaccination in this study
Have functional or surgical asplenia
Have a positive urine drug screen (unless the subject is currently prescribed the drug detected by a licensed health care provider and the continued administration of the drug would not otherwise exclude the subject from participation)
Have a known or suspected problem with alcohol or drug abuse
Were administered an investigational drug within six weeks prior to study entry
Are concurrently participating in a clinical study that includes the administration of an investigational product
Are a member of the team conducting this study
Are in a dependent relationship with the study Investigator or with a study team member. Dependent relationships include close relatives (i.e. children, partner/spouse, siblings, parents) as well as employees of the Investigator or site conducting the study
If female: are pregnant or lactating

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen)	Following review of safety data of Cohort 1, approximately 360 additional subjects randomized in an equal number to the six different vaccine doses
Cohort 1	H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen)	60 subjects randomized in an equal number to six different vaccine doses

Primary Outcome Measures

Name	Time	Method
Number of subjects with an antibody response to the vaccine strain associated with protection 21 days after the second vaccination	42 days

Secondary Outcome Measures

Name	Time	Method
Frequency and severity of systemic reactions and injection site reactions after the first and second vaccinations	180 days

Trial Locations

Locations (6)

Heartland Research Associates, LLC

🇺🇸

Wichita, Kansas, United States

Central Kentucky Research Associates, Inc.

🇺🇸

Lexington, Kentucky, United States

Rochester Clinical Research

🇺🇸

Rochester, New York, United States

Omega Medical Research

🇺🇸

Warwick, Rhode Island, United States

Research Across America

🇺🇸

Dallas, Texas, United States

The Center for Pharmaceutical Research

🇺🇸

Kansas City, Missouri, United States

Phase 1 Study of a H5N1 Influenza Vaccine (Reverse Genetic Reassortant)

Recruitment & Eligibility

Study & Design

Trial Locations

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