Pandemic Influenza Plasmid DNA Vaccines (Needle-Free)

NCT00694213 | Completed Phase 1 DMC

• 1 other identifier: IPT1-102
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 3

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.

Conditions

Influenza

Keywords

Pandemic Influenza; Avian Influenza; DNA Vaccines; Antibody; T Cells; HA/NP/M2; Biojector

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (4)

1

EXPERIMENTAL

Biological: VCL-IPM1

2

EXPERIMENTAL

Biological: VCL-IPM1

3

EXPERIMENTAL

Biological: VCL-IPT1

4

PLACEBO COMPARATOR

Biological: PBS

Interventions

VCL-IPM1 BIOLOGICAL

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

1

VCL-IPT1 BIOLOGICAL

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

3

PBS BIOLOGICAL

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

Also known as: Phosphate Buffered Saline

4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 45 years of age
• Able to provide informed consent and be followed for 6 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Vical: lead

Study Sites (3)

Accelovance

San Diego, California, 92108, United States

Location

SNBL

Baltimore, Maryland, 21201, United States

Location

SUNY at Stonybrook, Stony Brook Medical Center

Stony Brook, New York, 11794-8153, United States

Location

MeSH Terms

Conditions

Influenza, Human; Influenza in Birds

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Bird Diseases; Animal Diseases

Study Officials

• Don Guterwill, BS, MT

  Vical

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2008
• First Posted: June 10, 2008
• Study Start: August 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: February 1, 2011
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

US (3)