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OpenTrials
Completed

NCT Number: NCT00694213

Pandemic Influenza Plasmid DNA Vaccines (Needle-Free)

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.

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Key information

Conditions

Influenza Animal Diseases Bird Diseases Infections Influenza in Birds Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Accelovance, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VCL-IPM1

Biological

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

VCL-IPT1

Biological

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

PBS

Biological

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

Other names: Phosphate Buffered Saline

Primary outcomes

  1. Safety and Tolerability of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 in adult subjects.

    Time frame: 6 months

Secondary outcomes

  1. Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Vical

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2011
First posted
Jun 10, 2008
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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