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Pandemic Influenza Plasmid DNA Vaccines (Needle)

Primary Purpose

Influenza

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

VCL-IPT1

VCL-IPM1

PBS

About this trial

This is an interventional prevention trial for Influenza focused on measuring Pandemic Influenza, Avian Influenza, DNA Vaccines, Antibody, T Cells, HA/NP/M2

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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

Sites / Locations

Accelovance
SNBL
SUNY at Stonybrook, Stony Brook Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00709800

First Posted

July 1, 2008

Last Updated

February 11, 2009

Sponsor

Vical

1. Study Identification

Unique Protocol Identification Number

NCT00709800

Brief Title

Pandemic Influenza Plasmid DNA Vaccines (Needle)

Official Title

A Phase 1, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of Pandemic Influenza Plasmid DNA Vaccines

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Vical

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

VCL-IPT1

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

VCL-IPT1

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

VCL-IPT1

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

VCL-IPM1

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

PBS

Other Intervention Name(s)

Phosphate Buffered Saline

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Don Guterwill, BS, MT

Organizational Affiliation

Vical

Official's Role

Study Chair

Facility Information:

Facility Name

Accelovance

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

SNBL

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

SUNY at Stonybrook, Stony Brook Medical Center

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794-8153

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.vical.com

Description

Related Info

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Pandemic Influenza Plasmid DNA Vaccines (Needle)

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