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Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) Universal Influenza Vaccine in Healthy Adults

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ClinicalTrials.gov Identifier: NCT00921947
Recruitment Status : Completed
First Posted : June 17, 2009
Results First Posted : August 22, 2011
Last Update Posted : August 24, 2011
Sponsor:
Information provided by (Responsible Party):
VaxInnate Corporation

Study Description
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Brief Summary:
  1. To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population.
  2. To assess the immunogenicity (anti-M2e serum antibody concentration) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. as measured by an enzyme-linked immunosorbent assay (ELISA) in a healthy adult population.

Condition or disease Intervention/treatment Phase
Influenza Biological: VAX102 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase II, Randomized, Open-Label Study to Evaluate the Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) in Healthy Adults
Study Start Date : June 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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Arm Intervention/treatment
Experimental: VAX102 IM
VAX102 given as 1 µg intramuscular (i.m.)
 Biological: VAX102
Universal M2e influenza vaccine
Other Name: STF2.4xM2e
Experimental: VAX102 SC
VAX102 given as a 2 µg subcutaneous (s.c.) dose
 Biological: VAX102
Universal M2e influenza vaccine
Other Name: STF2.4xM2e


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) [ Time Frame: 0 to 7 days after vaccination ]
    Solicited local and general symptoms experienced within 7 days after vaccination 1.

  2. Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) [ Time Frame: 14 days after vaccination ]
    Solicited local and general symptoms experienced within 14 days after vaccination 2


Secondary Outcome Measures :
  1. Anti-M2e Serum Antibody Concentration [ Time Frame: 42 days (+/- 2) ]
    Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population.


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

Inclusion Criteria:

  • Adult men or women aged 18 to 49 years inclusive.
  • Able and willing to provide written informed consent to participate.
  • Healthy, as determined by medical history, physical examination, and vital signs.
  • Willing to receive the unlicensed (VAX102) vaccine given as an i.m. or s.c. injection.
  • Willing to provide multiple blood specimens collected by venipuncture.
  • Females should avoid becoming pregnant during the course of the study
  • Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of the first and preceding receipt of the second (booster) vaccination.
  • Must exhibit comprehension of the study requirements; expressed availability for the required study period and expect to reside in the study area during the entire study period, and ability to attend scheduled visits.

Exclusion Criteria:

  • Persons under 18 years old or 50 years or older.
  • Persons with chronic illnesses such as cancer, diabetes, liver or kidney disease.
  • Person currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination.
  • Persons who have had a prior serious reaction to influenza vaccine.
  • Persons with a history of anaphylactic-type reaction to injected vaccines.
  • Persons with a history of drug or chemical abuse in the year preceding the study.
  • Persons who received an influenza vaccine for the current influenza season or those who plan to receive an influenza vaccine while participating in the study.
  • Persons who received any other vaccine within one week prior to enrollment (may delay enrollment).
  • Persons who have had a respiratory illness or illness with fever within three days of study enrollment (may delay enrollment).
  • Persons currently participating in another research study involving any study medications (medicines or vaccines).
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00921947


Locations
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United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
VaxInnate Corporation
Investigators
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Study Director: David N Taylor, MD VaxInnate Corporation
More Information
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Responsible Party: VaxInnate Corporation
ClinicalTrials.gov Identifier: NCT00921947    
Other Study ID Numbers: VAX102-09
First Posted: June 17, 2009    Key Record Dates
Results First Posted: August 22, 2011
Last Update Posted: August 24, 2011
Last Verified: August 2011
Keywords provided by VaxInnate Corporation:
influenza vaccine
M2e
Universal influenza vaccine
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases