Pandemic Influenza Plasmid DNA Vaccines (Needle-Free)

Phase 1

Completed

• Conditions: Influenza
• Interventions: Biological: PBS; Biological: VCL-IPM1; Biological: VCL-IPT1

• Registration Number: NCT00694213
• Lead Sponsor: Vical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-06-06
• Study First Submitted QC: 2008-06-06
• Study First Posted: 2008-06-10
• Primary Completion: 2008-09
• Study Completion: 2011-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	PBS	-
1	VCL-IPM1	-
3	VCL-IPT1	-
2	VCL-IPM1	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000	6 months

Trial Locations

Locations (3)

Accelovance; 🇺🇸 San Diego, California, United States

SNBL; 🇺🇸 Baltimore, Maryland, United States

SUNY at Stonybrook, Stony Brook Medical Center; 🇺🇸 Stony Brook, New York, United States