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NCT00709800 Clinical Trial

Pandemic Influenza Plasmid DNA Vaccines (Needle)

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00709800
Other study ID # IPT1-101
Secondary ID
Status Completed
Phase Phase 1
First received July 1, 2008
Last updated February 11, 2009
Start date August 2007

Study information
Verified date February 2009
Source Vical
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• VCL-IPT1
IM, 0.1 mg/mL, 2 injections, 0 and 21 days
• VCL-IPT1
IM, 0.5 mg/mL, 2 injections, 0 and 21 days
• VCL-IPT1
IM, 1 mg/mL, 2 injections, 0 and 21 days
• VCL-IPM1
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 in adult subjects 6 months Yes
Secondary Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1 6 months No
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