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Study of the Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01658800
Recruitment Status : Completed
First Posted : August 7, 2012
Last Update Posted : March 6, 2015
Information provided by (Responsible Party):
VaxInnate Corporation

Brief Summary:
The purpose of this study is to test an investigational vaccine known as "VAX161C." An "investigational" vaccine is one that is not licensed for commercial use in the by the United States (US) by the US Food and Drug Administration (FDA). VAX161C is a vaccine for the influenza A virus subtype H5N1 avian influenza virus (bird flu). In this study, the subject will receive the VAX161C vaccine at one of six doses to see which dose is the best. VaxInnate wants to find out how safe these doses of vaccines are and how well they are tolerated by people who receive them. To measure how effective each type of the vaccine is, VaxInnate will test the ability of the body to develop an immune response, which means how the body recognizes and defends itself against the influenza virus.

Condition or disease Intervention/treatment Phase
Influenza Biological: VAX161C vaccine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 275 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase I Study of the Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49
Study Start Date : September 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: VAX161C vaccine
Subjects will be injected into the arm on 2 occasions during the study, once on Day 0 and then again on Day 21 with the vaccine VAX161C
Biological: VAX161C vaccine
Recombinant H5 influenza vaccine, VAX161C

Primary Outcome Measures :
  1. Safety [ Time Frame: 1 year ]
    Assess safety, reactogenicity and tolerability. Symptoms will be collected from the memory aid adn from the information collected at the clinic visits. All symptoms will be graded according to severity. Response to vaccine will be categorized as local (arm pain, redness, bruising, etc.) or systemic (headace, muscle aches, fatigue, etc.) symptoms. Laboratory tests such as CRP, WBC, LFTs and cytokines collected before and after vaccination will also be analyzed. We will compare the types and severity of symptoms and laboratory results based on vaccine dose.

Secondary Outcome Measures :
  1. Immunogenicity [ Time Frame: 6 months ]
    To assess serum immune response, sera collected at Days 0, 21, 42 and 180 will be analyzed for HAI, MN, serum IgG anti-HA and serum IgG anti-flagellin by Elisa. The geometric mean, seroconversion and seroprotection rates will be determined.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • Male or female aged 18 - 49 years
  • Give written informed consent
  • Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations
  • Females should not be pregnant and not lactating and fulfill one of the following criteria: At least one year post-menopausal;Surgically sterile;Will use oral, implantable, transdermal or injectable contraceptives for 30 days prior to first vaccination and until 28 days after vaccination
  • Willing to use another reliable form of contraception approved by the Investigator for study duration and until 28 days after vaccination.
  • Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of vaccination
  • Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits
  • Willing to receive the unlicensed (VAX161) vaccine given as an i.m. injection.
  • Willing to provide multiple blood specimens collected by venipuncture.


  • Persons who have a psychiatric illness, a chronic illness, or who are taking a concomitant therapy or have any other condition that would interfere with the subject's participation in the study or interpretation of the study results.
  • Persons with clinically significant abnormal liver function tests at screening.
  • Positive serology for HBsAg, HCV or HIV antibodies.
  • Persons having cancer or have received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible), excluding basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), which are allowed unless located at the vaccination site.
  • Persons with impaired immune responsiveness, including diabetes mellitus.
  • Persons presently receiving or having a recent history of receiving any medication or therapeutic modality that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, radiation therapy, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids.
  • Persons who have received or plan to receive a nonstudy vaccine within 30 days prior to vaccination and during 42 day study period following vaccination, including licensed influenza vaccines.
  • history of anaphylactic type reaction to injected vaccines.
  • history of drug or chemical abuse in the year prior to screening.
  • history of Guillain-Barré Syndrome.
  • have received, or plan to receive, any investigational product or non-registered drug within 30 days prior to vaccination and during the 42 day study period after vaccination.
  • Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the 42 day study period following vaccination.
  • Donation of blood or blood products within 8 weeks prior to vaccination or at any time during the study.
  • Acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness with or without fever, or a fever > 100.4° F orally.
  • significant cardiovascular disease e.g., New York Heart Association (NYHA) Class 3 or 4 congestive heart failure; myocardial infarction within the past six months; unstable angina, coronary angioplasty within the past six months; uncontrolled ventricular cardiac arrhythmias; resting heart rate (HR) >100 beats per minute (bpm).
  • history of chronic obstructive pulmonary disease or history of other lung disease.
  • Any condition that, in the opinion of the investigator, might interfere with study objectives.
  • Previously received an H5 or avian influenza vaccine, including VAX161.
  • Persons with a BMI ≥40

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01658800

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United States, Florida
Miami Research Associates
South Miami, Florida, United States, 33143
United States, Kansas
Johnson County Clinical Trials
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
VaxInnate Corporation
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Study Director: David Taylor, MD VaxInnate Corporation

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Responsible Party: VaxInnate Corporation Identifier: NCT01658800    
Other Study ID Numbers: VAX161-01C
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Keywords provided by VaxInnate Corporation:
H5N1 Influenza
H5N1 Influenza vaccine
Additional relevant MeSH terms:
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Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs