Pandemic Influenza Plasmid DNA Vaccines (Needle)

Vical

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Biological: PBS; Biological: VCL-IPT1; Biological: VCL-IPM1

Study type: Interventional

Funder types: Industry

Identifiers

NCT00709800

IPT1-101

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 5 patient groups, including a placebo group

2

Experimental group

Treatment:

Biological: VCL-IPT1

Biological: VCL-IPT1

Biological: VCL-IPT1

3

Experimental group

Treatment:

Biological: VCL-IPT1

Biological: VCL-IPT1

Biological: VCL-IPT1

4

Experimental group

Treatment:

Biological: VCL-IPM1

5

Placebo Comparator group

Treatment:

Biological: PBS

1

Experimental group

Treatment:

Biological: VCL-IPT1

Biological: VCL-IPT1

Biological: VCL-IPT1