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

Completed · Phase 1

Conditions studied: Human Immunodeficiency Virus, HIV Infections

In brief

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.

Key facts

Study ID

NCT00187148

Run by

St. Jude Children's Research Hospital

People needed

6

Starts

2005-02-01

Expected to finish

2009-11-01

Last updated by the study team

2017-04-26

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.