Trial record 3 of 17 for:    M2e

Open-label Study to Investigate the Humoral and Cellular Immune Response to Two Doses of VAX102 Influenza Vaccine in Healthy Adults

This study has been completed.
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by:
VaxInnate Corporation
ClinicalTrials.gov Identifier:
NCT00921206
First received: June 15, 2009
Last updated: February 4, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: VAX102
Phase 1

VaxInnate Corporation has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Open-label Study to Investigate the Humoral and Cellular Immune Response to Two Doses of VAX102 Influenza Vaccine in Healthy Adults

Resource links provided by NLM:


Further study details as provided by VaxInnate Corporation:

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. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2009
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VAX102 given i.m.
Universal influenza candidate vaccine
Biological: VAX102
1 ug i.m. compared to 2 ug s.c.
Other Name: STF2.4xM2e
Active Comparator: VAX102 given s.c.
Universal influenza candidate vaccine
Biological: VAX102
1 ug i.m. compared to 2 ug s.c.
Other Name: STF2.4xM2e

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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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: NCT00921206

Locations
United States, Colorado
Universite of Colorado, Denver
Denver, Colorado, United States, 80045
Sponsors and Collaborators
VaxInnate Corporation
University of Colorado, Denver
Investigators
Principal Investigator: Edward Janoff, MD University of Colorado, Denver
  More Information

Additional Information:
No publications provided

Responsible Party: David N. Taylor, MD, VaxInnate Corp
ClinicalTrials.gov Identifier: NCT00921206     History of Changes
Other Study ID Numbers: VAX102-05
Study First Received: June 15, 2009
Last Updated: February 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by VaxInnate Corporation:
influenza
influenza vaccine
universal influenza vaccine
Matrix 2e protein
M2e
Immune response

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

ClinicalTrials.gov processed this record on July 23, 2014