Pandemic Influenza Plasmid DNA Vaccines (Needle-Free) | NCT00694213

Studies
Pandemic Influenza Plasmid DNA Vaccines (Needle-Free)

NCT00694213

Sponsor

Vical

Status

Completed

Last Update Posted

Feb 27, 2019Actual

Enrollment

47Actual

Phase

Phase 1

Conditions

Influenza

Interventions

VCL-IPM1
VCL-IPM1
VCL-IPT1
PBS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Sep 2008Actual

Completion Date

Feb 2011Actual

First Submitted Date

Jun 6, 2008

First Submission Date that Met QC Criteria

Jun 6, 2008

First Posted Date

Jun 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2019

Last Update Posted Date

Feb 27, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Experimental	Biological: VCL-IPM1
2	Experimental	Biological: VCL-IPM1
3	Experimental	Biological: VCL-IPT1
4	Placebo Comparator	Biological: PBS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VCL-IPM1	Biological	IM, 0.5 mg/mL, 2 injections, 0 and 21 days	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and Tolerability of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 in adult subjects.		6 months

Secondary Outcomes

Measure	Description	Time Frame
Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000		6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Don Guterwill, BS, MT	Vical	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Accelovance		San Diego	California	92108	United States
SNBL

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human
D005585	Influenza in Birds

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided