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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00187148
First received: September 12, 2005
Last updated: June 1, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus
HIV Infections
Biological: EnvDNA
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Tolerability and Safety of a Recombinant HIV-1 Multi-Envelope DNA Plasmid Vaccine (EnvDNA) in Healthy Adults

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • To evaluate the tolerability and safety of the EnvDNA vaccine [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the kinetics, duration and magnitude of any HIV-envelope specific immune response elicited by EnvDNA [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: February 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Biological: EnvDNA
administered as 100 mcg of DNA in 1.5mL PBS every 28 days for 3 injections

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187148

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Pat Flynn, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Patricia Flynn, M.D., Principal Investigator, St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00187148     History of Changes
Other Study ID Numbers: EnvDNA, IND11130
Study First Received: September 12, 2005
Last Updated: June 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:
Vaccine
Prevention
HIV
AIDS

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014