Clinical trial NCT00187148: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Immunodeficiency Virus
HIV Infections
Keywords: Vaccine
Prevention
HIV
AIDS
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-09-16
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: To evaluate the tolerability and safety of the EnvDNA vaccine
timeFrame: 1 year
Secondary outcomes:
measure: To characterize the kinetics, duration and magnitude of any HIV-envelope specific immune response elicited by EnvDNA
timeFrame: 1 year
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Pat Flynn, MD
role: PRINCIPAL_INVESTIGATOR
References: