Pandemic Influenza Plasmid DNA Vaccines (Needle)

February 11, 2009 updated by: Vical

A Phase 1, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of Pandemic Influenza Plasmid DNA Vaccines

The trial will enroll up to 57 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with a needle 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 response will be studied throughout the trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92108
        • Accelovance
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • SNBL
    • New York
      • Stony Brook, New York, United States, 11794-8153
        • SUNY at Stonybrook, Stony Brook Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Biological: VCL-IPT1
IM, 1 mg/mL, 2 injections, 0 and 21 days
Biological: VCL-IPT1
IM, 0.1 mg/mL, 2 injections, 0 and 21 days
Biological: VCL-IPT1
IM, 0.5 mg/mL, 2 injections, 0 and 21 days
Experimental: 2
Biological: VCL-IPT1
IM, 1 mg/mL, 2 injections, 0 and 21 days
Biological: VCL-IPT1
IM, 0.1 mg/mL, 2 injections, 0 and 21 days
Biological: VCL-IPT1
IM, 0.5 mg/mL, 2 injections, 0 and 21 days
Experimental: 3
Biological: VCL-IPT1
IM, 1 mg/mL, 2 injections, 0 and 21 days
Biological: VCL-IPT1
IM, 0.1 mg/mL, 2 injections, 0 and 21 days
Biological: VCL-IPT1
IM, 0.5 mg/mL, 2 injections, 0 and 21 days
Experimental: 4
Biological: VCL-IPM1
IM, 1 mg/mL, 2 injections, 0 and 21 days
Placebo Comparator: 5
Biological: PBS
IM, 1 mL, 2 injections, 0 and 21 days
Other Names:
  • Phosphate Buffered Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability of VCL-IPT1 and VCL-IPM1 in adult subjects
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vical

Investigators

  • Study Chair: Don Guterwill, BS, MT, Vical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

July 1, 2008

First Submitted That Met QC Criteria

July 1, 2008

First Posted (Estimate)

July 3, 2008

Study Record Updates

Last Update Posted (Estimate)

February 12, 2009

Last Update Submitted That Met QC Criteria

February 11, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPT1-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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