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

St. Jude Children's Research Hospital

Status and phase

Completed

Phase 1

Conditions

Human Immunodeficiency Virus

HIV Infections

Treatments

Biological: EnvDNA

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00187148

IND11130

EnvDNA

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts 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