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Evaluate Tolerability of a Recombinant DNA HIV-1 Vaccine in Healthy Adults

Primary Purpose

Human Immunodeficiency Virus, HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EnvDNA
Sponsored by
St. Jude Children's Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus focused on measuring Vaccine, Prevention, HIV, AIDS

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy adults; age greater than 18 years, less than or equal to 40 years HIV-1 negative as documented by negative ELISA and negative Western blot analysis within 30 days prior to immunization Normal history and physical exam Normal complete blood count and differential obtained within 60 days prior to immunization, and defined as: hemoglobin greater than or equal to 12.0 gm/dl for females and greater than or equal to 14.0 gm/dl for males white blood cell count greater than or equal to 3500 cells/mm3 platelet count between 150,000 and 550,000 cells/mm3 CD4+ T cell count greater than or equal to 400 cells/mm3 (if a single CD4+ T cell count <400 cells/mm3 is obtained, a repeat count will be performed and immunization will proceed if the repeat count is greater than or equal to 400 cells/mm3) Anti-nuclear antibody titer <1:80 (by IFA) and negative anti-DNA antibody within 60 days prior to immunization Negative for Hepatitis B surface antigen and Hepatitis C AST and ALT within normal institutional limits obtained within 60 days prior to immunization Serum creatinine, Na+, K+ and Cl- within normal institutional limits, obtained within 60 days prior to immunization Serum creatine phosphokinase (CPK) within normal institutional limits obtained within 60 days prior to immunization Not planning to become pregnant during study vaccinations and for three months after last vaccination Availability for at least one year of follow-up Exclusion Criteria: History of immunosuppressive illness, chronic illness (e.g. asthma, diabetes, hypertension, bleeding diathesis, etc), or Receiving therapy or prophylaxis for tuberculosis Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol. Specifically excluded are persons with a history of suicide attempts, recent suicidal ideation or who have past or present psychosis Live attenuated vaccines within 60 days of study enrollment (Note: subunit or killed vaccines [e.g. influenza or pneumococcal] are not exclusionary, but should be given at least 2 weeks before or after HIV immunization) Use of experimental agents within 30 days prior to study enrollment Receipt of blood products or immunoglobulin in the past 6 months Subjects with known allergy to the antibiotic kanamycin Pregnancy at the time of vaccination (urine pregnancy test) Nursing mother at the time of vaccination Any member of the Investigator's laboratory program Participation in previous HIV vaccine trial

Sites / Locations

  • St. Jude Children's Research Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the tolerability and safety of the EnvDNA vaccine

Secondary Outcome Measures

To characterize the kinetics, duration and magnitude of any HIV-envelope specific immune response elicited by EnvDNA

Full Information

First Posted
September 12, 2005
Last Updated
April 24, 2017
Sponsor
St. Jude Children's Research Hospital
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00187148
Brief Title
Evaluate Tolerability of a Recombinant DNA HIV-1 Vaccine in Healthy Adults
Official Title
Evaluation of the Tolerability and Safety of a Recombinant HIV-1 Multi-Envelope DNA Plasmid Vaccine (EnvDNA) in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Jude Children's Research Hospital
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This protocol will evaluate the safety and tolerability of the vaccine EnvDNA in healthy adults. DNA-based vaccines are being studied for the prevention of human immunodeficiency virus (HIV), malaria and hepatitis. DNA vaccines have been well tolerated in human studies to date. The vaccine that will be tested in this study was made from the information that the virus uses to make a small part of the HIV. This small part is called the envelope or coating around the virus. We hope the body will make an immune response against the HIV envelope coat. Our potential HIV DNA envelope vaccine is called EnvDNA.
Detailed Description
This is a research (investigational) study to find out about the safety of a new potential vaccine for HIV. This potential vaccine may eventually become a part of a sequence of three experimental vaccines that will be studied to see if they can help to protect people from HIV. HIV infection is the cause of AIDS (Acquired Immune Deficiency Syndrome). AIDS is one of the most serious viral infections we know. This study is being done to help us find an HIV vaccine that works. The vaccine that will be tested in this study was made from the information that the virus uses to make a small part of the HIV. This small part is called the envelope or coating around the virus. Because only the information for this one part of the virus is used in the vaccine, the vaccine cannot cause HIV infection. We make the vaccine in a test tube. The vaccine is made up of DNA. DNA is like an instruction manual that cells use to make basic building blocks called proteins. This DNA has the information that cells will use to make the envelope coat of HIV. Once the DNA is injected intramuscularly, it should tell cells to make the envelope protein. We hope the body will make an immune response against the HIV envelope coat. Our potential HIV DNA envelope vaccine is called EnvDNA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, HIV Infections
Keywords
Vaccine, Prevention, HIV, AIDS

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
EnvDNA
Intervention Description
administered as 100 mcg of DNA in 1.5mL PBS every 28 days for 3 injections
Primary Outcome Measure Information:
Title
To evaluate the tolerability and safety of the EnvDNA vaccine
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To characterize the kinetics, duration and magnitude of any HIV-envelope specific immune response elicited by EnvDNA
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults; age greater than 18 years, less than or equal to 40 years HIV-1 negative as documented by negative ELISA and negative Western blot analysis within 30 days prior to immunization Normal history and physical exam Normal complete blood count and differential obtained within 60 days prior to immunization, and defined as: hemoglobin greater than or equal to 12.0 gm/dl for females and greater than or equal to 14.0 gm/dl for males white blood cell count greater than or equal to 3500 cells/mm3 platelet count between 150,000 and 550,000 cells/mm3 CD4+ T cell count greater than or equal to 400 cells/mm3 (if a single CD4+ T cell count <400 cells/mm3 is obtained, a repeat count will be performed and immunization will proceed if the repeat count is greater than or equal to 400 cells/mm3) Anti-nuclear antibody titer <1:80 (by IFA) and negative anti-DNA antibody within 60 days prior to immunization Negative for Hepatitis B surface antigen and Hepatitis C AST and ALT within normal institutional limits obtained within 60 days prior to immunization Serum creatinine, Na+, K+ and Cl- within normal institutional limits, obtained within 60 days prior to immunization Serum creatine phosphokinase (CPK) within normal institutional limits obtained within 60 days prior to immunization Not planning to become pregnant during study vaccinations and for three months after last vaccination Availability for at least one year of follow-up Exclusion Criteria: History of immunosuppressive illness, chronic illness (e.g. asthma, diabetes, hypertension, bleeding diathesis, etc), or Receiving therapy or prophylaxis for tuberculosis Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol. Specifically excluded are persons with a history of suicide attempts, recent suicidal ideation or who have past or present psychosis Live attenuated vaccines within 60 days of study enrollment (Note: subunit or killed vaccines [e.g. influenza or pneumococcal] are not exclusionary, but should be given at least 2 weeks before or after HIV immunization) Use of experimental agents within 30 days prior to study enrollment Receipt of blood products or immunoglobulin in the past 6 months Subjects with known allergy to the antibiotic kanamycin Pregnancy at the time of vaccination (urine pregnancy test) Nursing mother at the time of vaccination Any member of the Investigator's laboratory program Participation in previous HIV vaccine trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pat Flynn, MD
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital

Learn more about this trial

Evaluate Tolerability of a Recombinant DNA HIV-1 Vaccine in Healthy Adults

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