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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VaxInnate Corporation
ClinicalTrials.gov Identifier:
NCT01658800
First received: July 30, 2012
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Influenza
Biological: VAX161-01C vaccine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by VaxInnate Corporation:

Primary Outcome Measures:
  • Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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:
  • Immunogenicity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 275
Study Start Date: September 2012
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VAX161-01C 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 VAX161-01C
Biological: VAX161-01C vaccine
Recombinant H5 influenza vaccine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION

  • 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.

EXCLUSION

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658800

Locations
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
Investigators
Study Director: David Taylor, MD VaxInnate Corporation
  More Information

No publications provided

Responsible Party: VaxInnate Corporation
ClinicalTrials.gov Identifier: NCT01658800     History of Changes
Other Study ID Numbers: VAX161-01C
Study First Received: July 30, 2012
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by VaxInnate Corporation:
H5N1 Influenza
H5N1 Influenza vaccine

Additional relevant MeSH terms:
Influenza in Birds
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014