Safety of and Immune Response to an HIV Vaccine (VRC-HIVDNA009-00-VP) Administered With Interleukin-2/Immunoglobulin (IL-2/Ig) DNA Adjuvant in Uninfected Adults
Completed · Phase 1
Conditions studied: HIV Infections
In brief
This study will test the safety of and immune system response to a new HIV vaccine. The vaccine in this study is made from HIV DNA produced in a laboratory. Only part of the virus's DNA is used in the vaccine and the vaccine itself cannot cause HIV infection or AIDS. In addition to HIV DNA, the vaccine contains interleukin-2 (IL-2) DNA fused to a portion of immunoglobulin (Ig) DNA. IL-2 is a chemical that stimulates the immune system and may improve response to the vaccine. Study hypothesis: The IL-2/Ig plasmid will be very well tolerated in humans.
Key facts
- Study ID
- NCT00069030
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 70
- Starts
- 2003-12-01
- Expected to finish
- 2006-12-01
- Last updated by the study team
- 2021-10-14
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- HIV negative
- Willing to receive HIV test results
- Good general health
- Acceptable methods of contraception for females of reproductive potential
- Hepatitis B surface antigen negative
- Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive
- Normal thyroid stimulating hormone (TSH) level
You may not qualify if…
- HIV vaccines or placebos in prior HIV vaccine trial
- Immunosuppressive medications within 168 days prior to first study vaccine administration
- Blood products within 120 days prior to first study vaccine administration
- Immunoglobulin within 60 days prior to first study vaccine administration
- Live attenuated vaccines within 30 days prior to first study vaccine administration
- Investigational research agents within 30 days prior to first study vaccine administration
- Subunit or killed vaccines within 14 days prior to first study vaccine administration
- Current tuberculosis prophylaxis or therapy
- Clinical depression with pharmacological treatment within the past 2 years
- Active syphilis
- Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
- Autoimmune disease or immunodeficiency
- Unstable asthma
- Type 1 or Type 2 Diabetes Mellitus
- Thyroid disease requiring treatment
- Serious angioedema within the past 3 years
- Uncontrolled hypertension
- Bleeding disorder
- Malignancy unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period
- Seizure disorder requiring medication within the past 3 years
- Asplenia
- Mental illness that would interfere with compliance with the protocol
- Other conditions that, in the judgement of the investigator, would interfere with the study
- Pregnant or breast-feeding
Where it is running
- Project Brave HIV Vaccine CRS — Baltimore, Maryland, United States
- Brigham and Women's Hosp. CRS — Boston, Massachusetts, United States
- Fenway Community Health Clinical Research Site (FCHCRS) — Boston, Massachusetts, United States
- NY Blood Ctr./Union Square CRS — New York, New York, United States
- HIV Prevention & Treatment CRS — New York, New York, United States
- NY Blood Ctr./Bronx CRS — The Bronx, New York, United States
- Miriam Hospital's HVTU — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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