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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VaxInnate Corporation
ClinicalTrials.gov Identifier:
NCT00921947
First received: June 15, 2009
Last updated: August 22, 2011
Last verified: August 2011

June 15, 2009
August 22, 2011
June 2009
July 2009   (final data collection date for primary outcome measure)
  • Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) [ Time Frame: 0 to 7 days after vaccination ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Solicited local and general symptoms experienced within 14 days after vaccination 2
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00921947 on ClinicalTrials.gov Archive Site
Anti-M2e Serum Antibody Concentration [ Time Frame: 42 days (+/- 2) ] [ Designated as safety issue: No ]
Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population.
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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
  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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Influenza
Biological: VAX102
Universal M2e influenza vaccine
Other Name: STF2.4xM2e
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2009
July 2009   (final data collection date for primary outcome measure)

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).
Both
18 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00921947
VAX102-09
No
VaxInnate Corporation
VaxInnate Corporation
Not Provided
Study Director: David N Taylor, MD VaxInnate Corporation
VaxInnate Corporation
August 2011

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