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NCT00694213 Clinical Trial

Pandemic Influenza Plasmid DNA Vaccines (Needle-Free)

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00694213
Other study ID # IPT1-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 2007
Est. completion date February 2011

Study information
Verified date February 2019
Source Vical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date February 2011
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• VCL-IPM1
IM, 0.5 mg/mL, 2 injections, 0 and 21 days
• VCL-IPM1
IM, 1 mg/mL, 2 injections, 0 and 21 days
• VCL-IPT1
IM, 1 mg/mL, 2 injections, 0 and 21 days
• PBS
IM, 1 mL, 2 injections, 0 and 21 days

Locations
Country Name City State
United States SNBL Baltimore Maryland
United States Accelovance San Diego California
United States SUNY at Stonybrook, Stony Brook Medical Center Stony Brook New York

Sponsors (1)
Lead Sponsor Collaborator
Vical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and Tolerability of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 in adult subjects. 6 months
Secondary Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 6 months
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