Pandemic Influenza Plasmid DNA Vaccines (Needle)

NCT ID: NCT00709800

Last Updated: 2009-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2

Group Type EXPERIMENTAL

VCL-IPT1

Intervention Type BIOLOGICAL

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

3

Group Type EXPERIMENTAL

VCL-IPT1

Intervention Type BIOLOGICAL

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

4

Group Type EXPERIMENTAL

VCL-IPM1

Intervention Type BIOLOGICAL

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

5

Group Type PLACEBO_COMPARATOR

PBS

Intervention Type BIOLOGICAL

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

1

Group Type EXPERIMENTAL

VCL-IPT1

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VCL-IPT1

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

Intervention Type BIOLOGICAL

VCL-IPT1

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

Intervention Type BIOLOGICAL

VCL-IPT1

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

Intervention Type BIOLOGICAL

VCL-IPM1

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

Intervention Type BIOLOGICAL

PBS

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

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Phosphate Buffered Saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Vical Incorporated

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Don Guterwill, BS, MT

Role: STUDY_CHAIR

Vical

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Accelovance

San Diego, California, United States

Site Status

SNBL

Baltimore, Maryland, United States

Site Status

SUNY at Stonybrook, Stony Brook Medical Center

Stony Brook, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IPT1-101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

BPL-1357 Against H1N1 Influenza Virus Challenge
NCT07215858 NOT_YET_RECRUITING PHASE2
Safety Study of Avian Flu Vaccine
NCT00408109 COMPLETED PHASE1