Pandemic Influenza Plasmid DNA Vaccines (Needle)

Vical56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Influenza

Interventions

VCL-IPT1BIOLOGICAL

IM, 0.1 mg/mL, 2 injections, 0 and 21 days

VCL-IPT1BIOLOGICAL

IM, 0.5 mg/mL, 2 injections, 0 and 21 days

VCL-IPT1BIOLOGICAL

IM, 1 mg/mL, 2 injections, 0 and 21 days

VCL-IPM1

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Safety and Tolerability of VCL-IPT1 and VCL-IPM1 in adult subjects

Time frame: 6 months

Secondary Outcomes

Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1

Time frame: 6 months

Data from ClinicalTrials.gov

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