Study to Investigate the Immune Response to Two Doses of VAX102 Healthy Adults
Primary Purpose
Influenza
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VAX102
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring influenza, influenza vaccine, universal influenza vaccine, Matrix 2e protein, M2e, Immune response
Eligibility Criteria
Inclusion Criteria:
- Male or female aged 18 - 49 years inclusive
- Give written informed consent to participate.
- Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations
- Females willing to practice birth control to avoid pregnancy during the study
- Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
Exclusion Criteria:
- Presence of significant acute or chronic, uncontrolled medical or psychiatric illness (institution of new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months) as determined by medical history and/or physical exam.
- Cancer, or treatment for cancer, within 3 years. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible
- Impaired immune responsiveness (of any cause), including diabetes mellitus.
- Documented influenza infection in the 6 months prior to study entry.
- Presently receiving or history of receiving any medications or treatments that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable) in the past 6 months. Inhaled and topical corticosteroids will be allowed.
- Receipt or planned administration of a nonstudy vaccine within 30 days before and during the study and through the Day 42 evaluation.
- History of anaphylactic type reaction to injected vaccines.
- History of drug or chemical abuse in the year before the study.
- Use of new prescription medications started within 7 days before study entry.
- Receipt of blood or blood products 8 weeks before study entry or planned administration during the study period.
- Donation of blood or blood products within 8 weeks before study entry or at any time during the study.
- Acute disease within 72 hours prior to vaccinations, defined as the presence of a moderate or severe illness (as determined by the investigator through medical history and physical examination; for example, those requiring an absence from work) with or without fever, or a fever >37.9ºC orally. Study vaccine can be administered to persons with a minor illness, such as diarrhea, or mild upper respiratory tract infection with or without low-grade febrile illness. Vaccination can be delayed until the subject has recovered.
- Any condition that, in the opinion of the investigator, might interfere with study objectives
Sites / Locations
- Universite of Colorado, Denver
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
VAX102 given i.m.
VAX102 given s.c.
Arm Description
Universal influenza candidate vaccine
Universal influenza candidate vaccine
Outcomes
Primary Outcome Measures
To assess the humoral and cellular immune response of the VAX102 vaccine delivered IM and SC in a prime-boost regimen at dose levels 1 µg or 2 µg in healthy adults against the influenza A virus M2e antigen after each vaccination.
Secondary Outcome Measures
To assess the safety, reactogenicity, and tolerability of the VAX102 vaccine delivered IM or SC at dose levels 1 µg or 2 µg, in a prime-boost dosing regimen, in healthy adults 18-49 years of age, inclusive.
Full Information
NCT ID
NCT00921206
First Posted
June 15, 2009
Last Updated
September 22, 2014
Sponsor
VaxInnate Corporation
Collaborators
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT00921206
Brief Title
Study to Investigate the Immune Response to Two Doses of VAX102 Healthy Adults
Official Title
Open-label Study to Investigate the Humoral and Cellular Immune Response to Two Doses of VAX102 Influenza Vaccine in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VaxInnate Corporation
Collaborators
University of Colorado, Denver
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective is to assess the humoral and cellular immune response of the VAX102 vaccine delivered IM and SC in a prime-boost regimen at dose levels 1 µg or 2 µg in healthy adults against the influenza A virus M2e antigen after each vaccination.
Detailed Description
The primary objective is to assess the humoral and cellular immune response of the VAX102 vaccine delivered IM and SC in a prime-boost regimen at dose levels 1 µg or 2 µg in healthy adults against the influenza A virus M2e antigen after each vaccination. The magnitude and quality of the M2e-specific B and T cells will be measured. B cell responses will be evaluated on pre-dose Days 0, 28 and post-dose Days 7, 35, 42 and 60. T cell responses will be measured on pre-dose Days 0, 28 and post-dose Days 14, 42 and 60. IgG M2e antibody will be measured on Days 0, 7, 14, 28, 35. 42 and 60. The secondary objective is to assess the safety, reactogenicity, and tolerability of the VAX102 vaccine delivered IM or SC at dose levels 1 µg or 2 µg, in a prime-boost dosing regimen, in healthy adults 18-49 years of age, inclusive.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza, influenza vaccine, universal influenza vaccine, Matrix 2e protein, M2e, Immune response
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VAX102 given i.m.
Arm Type
Active Comparator
Arm Description
Universal influenza candidate vaccine
Arm Title
VAX102 given s.c.
Arm Type
Active Comparator
Arm Description
Universal influenza candidate vaccine
Intervention Type
Biological
Intervention Name(s)
VAX102
Other Intervention Name(s)
STF2.4xM2e
Intervention Description
1 ug i.m. compared to 2 ug s.c.
Primary Outcome Measure Information:
Title
To assess the humoral and cellular immune response of the VAX102 vaccine delivered IM and SC in a prime-boost regimen at dose levels 1 µg or 2 µg in healthy adults against the influenza A virus M2e antigen after each vaccination.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
To assess the safety, reactogenicity, and tolerability of the VAX102 vaccine delivered IM or SC at dose levels 1 µg or 2 µg, in a prime-boost dosing regimen, in healthy adults 18-49 years of age, inclusive.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female aged 18 - 49 years inclusive
Give written informed consent to participate.
Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations
Females willing to practice birth control to avoid pregnancy during the study
Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
Exclusion Criteria:
Presence of significant acute or chronic, uncontrolled medical or psychiatric illness (institution of new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months) as determined by medical history and/or physical exam.
Cancer, or treatment for cancer, within 3 years. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible
Impaired immune responsiveness (of any cause), including diabetes mellitus.
Documented influenza infection in the 6 months prior to study entry.
Presently receiving or history of receiving any medications or treatments that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable) in the past 6 months. Inhaled and topical corticosteroids will be allowed.
Receipt or planned administration of a nonstudy vaccine within 30 days before and during the study and through the Day 42 evaluation.
History of anaphylactic type reaction to injected vaccines.
History of drug or chemical abuse in the year before the study.
Use of new prescription medications started within 7 days before study entry.
Receipt of blood or blood products 8 weeks before study entry or planned administration during the study period.
Donation of blood or blood products within 8 weeks before study entry or at any time during the study.
Acute disease within 72 hours prior to vaccinations, defined as the presence of a moderate or severe illness (as determined by the investigator through medical history and physical examination; for example, those requiring an absence from work) with or without fever, or a fever >37.9ºC orally. Study vaccine can be administered to persons with a minor illness, such as diarrhea, or mild upper respiratory tract infection with or without low-grade febrile illness. Vaccination can be delayed until the subject has recovered.
Any condition that, in the opinion of the investigator, might interfere with study objectives
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Janoff, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universite of Colorado, Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.vaxinnate.com/
Description
Sponsor website
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Study to Investigate the Immune Response to Two Doses of VAX102 Healthy Adults
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