Status:
COMPLETED
Evaluate Tolerability of a Recombinant DNA HIV-1 Vaccine in Healthy Adults
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Human Immunodeficiency Virus
HIV Infections
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
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 ...
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 vacc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00187148
Start Date
February 1 2005
End Date
November 1 2009
Last Update
April 26 2017
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105