NCT00709800

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Last Updated

February 12, 2009

Status Verified

February 1, 2009

Enrollment Period

1.1 years

First QC Date

July 1, 2008

Last Update Submit

February 11, 2009

Conditions

Influenza

Keywords

Pandemic InfluenzaAvian InfluenzaDNA VaccinesAntibodyT CellsHA/NP/M2

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

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

    6 months

Study Arms (5)

2

EXPERIMENTAL
Biological: VCL-IPT1

3

EXPERIMENTAL
Biological: VCL-IPT1

4

EXPERIMENTAL
Biological: VCL-IPM1

5

PLACEBO COMPARATOR
Biological: PBS

1

EXPERIMENTAL
Biological: VCL-IPT1

Interventions

VCL-IPT1BIOLOGICAL

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

1
VCL-IPM1BIOLOGICAL

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

4
PBSBIOLOGICAL

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

Also known as: Phosphate Buffered Saline
5

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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, HumanInfluenza in Birds

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesBird DiseasesAnimal 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

Study Record Dates

First Submitted

July 1, 2008

First Posted

July 3, 2008

Study Start

August 1, 2007

Primary Completion

September 1, 2008

Last Updated

February 12, 2009

Record last verified: 2009-02

Locations

US(3)