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Pandemic Influenza Plasmid DNA Vaccines (Needle-Free)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00694213
Recruitment Status : Completed
First Posted : June 10, 2008
Last Update Posted : February 12, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
The trial will enroll up to 47 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with the Biojector® 2000, and will be followed for 6 months to evaluate the safety of and the immune system's response to the vaccine. The safety and immune system's response will be studied throughout the trial.

Condition or disease Intervention/treatment Phase
Influenza Biological: VCL-IPM1 Biological: VCL-IPT1 Biological: PBS Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 1, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of Pandemic Influenza Plasmid DNA Vaccines Administered With the Biojector® 2000 Needle-Free System
Study Start Date : August 2007
Primary Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Biological: VCL-IPM1
IM, 0.5 mg/mL, 2 injections, 0 and 21 days
Experimental: 2 Biological: VCL-IPM1
IM, 1 mg/mL, 2 injections, 0 and 21 days
Experimental: 3 Biological: VCL-IPT1
IM, 1 mg/mL, 2 injections, 0 and 21 days
Placebo Comparator: 4 Biological: PBS
IM, 1 mL, 2 injections, 0 and 21 days
Other Name: Phosphate Buffered Saline


Outcome Measures

Primary Outcome Measures :
  1. Safety and Tolerability of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 in adult subjects. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 to 45 years of age
  • Able to provide informed consent and be followed for 6 months

Exclusion Criteria:

  • No immunomodulatory therapy within the past 6 months
  • No evidence of immunodeficiency or pregnancy
  • No laboratory or evidence of clinically significant medical disease
  • No history of previous pDNA immunization
  • No influenza immunization within the past 30 days
  • No blood donations within 30 days of screening visit
  • No history of bleeding disorder
  • No use of aspirin and/or anticoagulants within 2 weeks of the administration of the investigational vaccines
Contacts and Locations

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): NCT00694213


Locations
United States, California
Accelovance
San Diego, California, United States, 92108
United States, Maryland
SNBL
Baltimore, Maryland, United States, 21201
United States, New York
SUNY at Stonybrook, Stony Brook Medical Center
Stony Brook, New York, United States, 11794-8153
Sponsors and Collaborators
Vical
Investigators
Study Chair: Don Guterwill, BS, MT Vical
More Information

Additional Information:
Responsible Party: Don Guterwill, BS, MT, Senior Clinical Project Manager, Vical Incorporated
ClinicalTrials.gov Identifier: NCT00694213     History of Changes
Other Study ID Numbers: IPT1-102
First Posted: June 10, 2008    Key Record Dates
Last Update Posted: February 12, 2009
Last Verified: February 2009

Keywords provided by Vical:
Pandemic Influenza
Avian Influenza
DNA Vaccines
Antibody
T Cells
HA/NP/M2
Biojector

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs