NCT00973895|CompletedPhase 1

VRC 308: An Open-Label Phase I Study of the Safety and Immunogenicity of an Investigational H1 DNA Influenza Vaccine, VRC-FLUDNA057-00-VP, in Healthy Adults 18-70 Years Old

National Institute of Allergy and Infectious Diseases (NIAID)ClinicalTrials.gov

Compare

Other study identifiers

Sponsor study identifier

090204

Secondary identifiers

09-I-0204

Study Type

interventional

Actual enrollment (reported)

Locations

1 country

Sites

Timeline

Study Start

August 6, 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 3, 2010

Actual (reported)

Study Completion

September 3, 2010

Actual (reported)

Brief Summary

Background:

Vaccines are substances used to try to create resistance (or immunity) to a disease and to prevent an infection. Researchers are testing a new DNA vaccine designed for a new type of influenza, often referred to as swine flu. The DNA vaccine will instruct the body to make a particular kind of influenza protein that the immune system will be able to recognize.
Researchers are interested in determining if the vaccine is safe and effective in humans, and would like to study the immune system's response to the vaccine. The vaccine will not give participants influenza; however, it may not be effective in preventing them from getting influenza at a later date. Objectives:
To evaluate the safety and tolerability of the VRC-FLUDNA057-00-VP influenza vaccine as administered to healthy adults.
To evaluate antibody responses to the new influenza vaccine. Eligibility: \- Healthy adults between the ages of 18 and 70. Design:
Participants will have seven planned clinic visits during this study (enrollment day and study weeks 1, 4, 8, 9, 12, and 32).
All participants will receive three injections of the test vaccine, given as individual doses on day 0, day 28, and day 56 of the study. The vaccine will be given in the upper arm muscle.
Injections will be given using a needleless system that delivers the vaccine through the skin by using the pressure of carbon dioxide to inject the vaccine through the skin and into the muscle. Participants will remain at the National Institutes of Health (NIH) Clinical Center for at least 30 minutes after the injection to be monitored for any reaction.
Participants will be asked to keep a 7-day diary card after each injection to record their physical reactions to the vaccine.
Participants will be asked to return to the NIH Clinical Center as requested by researchers for additional blood tests and other procedures, as required by the study.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 20 participants
Study completion date: September 3, 2010
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 6, 2009
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 5, 2009
Actual (reported)
First Posted
September 9, 2009
Actual (reported)
Primary Completion
September 3, 2010
Actual (reported)
Study Completion
September 3, 2010
Actual (reported)

Last Updated: July 2, 2017
Status Verified: September 3, 2010
Last Update Submitted: June 30, 2017

Conditions

Influenza A Virus, H1N1 Subtype Novel Swine-Origin

Keywords

InfluenzaHealthyImmunityPreventivePandemic

Outcome Measures

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

to 70 years old.
Available for clinical follow-up through Week 32.
Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly.
Able and willing to complete the informed consent process.
Willing to donate blood for sample storage to be used for future research.
No evidence of previously undiagnosed clinically significant chronic diseases.
Physical examination and laboratory results without clinically significant findings, no fever (greater than or equal to 100.4 degree F) in the 72 hours prior to enrollment, and a Body Mass Index (BMI) greater than or equal to 18 and \< 42 within the 56 days prior to enrollment.
Laboratory Criteria within 56 days prior to enrollment:
Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men
White blood cells (WBC) = 3,300-12,000 cells/mm(3)
Differential either within institutional normal range or accompanied by site physician approval as a differential that is consistent with healthy volunteer status
Total lymphocyte count greater than or equal to 800 cells/mm(3)
Platelets = 125,000 - 500,000/mm(3)
Alanine aminotransferase (ALT) less than or equal to 2.5 times upper limit of normal (ULN)
+13 more criteria

You may not qualify if:

Women Specific:
Breast-feeding or planning to become pregnant during the first 32 weeks after enrollment in the study.
Subject has received any of the following substances:
Systemic immunosuppressive medications or cytotoxic medications within the 12 weeks prior to enrollment. \[With the exceptions that a short course (duration of 10 days or less or a single injection) of corticosteroids for a self-limited condition at least 2 weeks prior to enrollment in this study will not exclude study participation.\]

Contact the study team to confirm eligibility.

VRC 308: An Open-Label Phase I Study of the Safety and Immunogenicity of an Investigational H1 DNA Influenza Vaccine, VRC-FLUDNA057-00-VP, in Healthy Adults 18-70 Years Old

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations