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Trial record 1 of 1 for:    NCT00921947
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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

Tracking Information
First Submitted Date  ICMJE June 15, 2009
First Posted Date  ICMJE June 17, 2009
Results First Submitted Date  ICMJE June 13, 2011
Results First Posted Date  ICMJE August 22, 2011
Last Update Posted Date August 24, 2011
Study Start Date  ICMJE June 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 15, 2009)
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. [ Time Frame: 2 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
Anti-M2e Serum Antibody Concentration [ Time Frame: 42 days (+/- 2) ]
Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2009)
To assess the anti-M2e serum antibody concentration after 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. [ Time Frame: 2 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE Biological: VAX102
Universal M2e influenza vaccine
Other Name: STF2.4xM2e
Study Arms  ICMJE
  • Experimental: VAX102 IM
    VAX102 given as 1 µg intramuscular (i.m.)
    Intervention: Biological: VAX102
  • Experimental: VAX102 SC
    VAX102 given as a 2 µg subcutaneous (s.c.) dose
    Intervention: Biological: VAX102
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00921947
Other Study ID Numbers  ICMJE VAX102-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VaxInnate Corporation
Study Sponsor  ICMJE VaxInnate Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David N Taylor, MD VaxInnate Corporation
PRS Account VaxInnate Corporation
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP