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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

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
History of Changes
  Purpose
  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 Intervention Phase
Influenza
 Biological: VAX102
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by VaxInnate Corporation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: June 2009
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921947

Locations
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
VaxInnate Corporation
Investigators
Study Director: David N Taylor, MD VaxInnate Corporation
  More Information

No publications provided

Responsible Party: VaxInnate Corporation
ClinicalTrials.gov Identifier: NCT00921947     History of Changes
Other Study ID Numbers: VAX102-09
Study First Received: June 15, 2009
Results First Received: June 13, 2011
Last Updated: August 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by VaxInnate Corporation:
influenza vaccine
M2e
Universal influenza vaccine

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 June 18, 2013