Pandemic Influenza Plasmid DNA Vaccines (Needle-Free)

Sponsor

Vical (Industry)

Overall Status

Completed

CT.gov ID

NCT00694213

Collaborator

(none)

Enrollment

Locations

Arms

42.1

Duration (Months)

15.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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-IPM1 Biological: VCL-IPT1 Biological: PBS	Phase 1

Study Design

Study Type:

Interventional

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 :

Aug 1, 2007

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Feb 1, 2011

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 Names: Phosphate Buffered Saline

Outcome Measures

Primary Outcome Measures

Safety and Tolerability of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 in adult subjects. [6 months]

Secondary Outcome Measures

Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Accelovance	San Diego	California	United States	92108
2	SNBL	Baltimore	Maryland	United States	21201
3	SUNY at Stonybrook, Stony Brook Medical Center	Stony Brook	New York	United States	11794-8153