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

NCT01658800 | Completed Phase 1 DMC

• 1 other identifier: VAX161-01C
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 2

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.

Conditions

Influenza

Keywords

H5N1 Influenza; H5N1 Influenza vaccine

Outcome Measures

Primary Outcomes (1)

• Safety

  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.

  1 year

Secondary Outcomes (1)

• Immunogenicity

  6 months

Study Arms (1)

VAX161C vaccine

EXPERIMENTAL

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

Interventions

VAX161C vaccine BIOLOGICAL

Recombinant H5 influenza vaccine, VAX161C

VAX161C vaccine

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• VaxInnate Corporation: lead

Study Sites (2)

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Johnson County Clinical Trials

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• David Taylor, MD

  VaxInnate Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 7, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

US (2)