Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Uninfected Adults

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to test the safety of an HIV DNA vaccine (EP HIV-1090) and to test whether or not the vaccine can stimulate immune system responses in HIV uninfected people. This vaccine uses only parts of the virus's DNA and cannot cause HIV infection.

Key facts

Study ID

NCT00054860

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

42

Expected to finish

2005-09-01

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
• Positive for one or more of the following HLA supertypes: -A2, -A3, or -B7
• 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

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
• 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 judgment of the investigator, would interfere with the study
• Pregnant or breast-feeding

Where it is running

• Brigham and Women's Hosp. CRS — Boston, Massachusetts, United States
• Fenway Community Health Clinical Research Site (FCHCRS) — Boston, Massachusetts, United States
• Saint Louis Univ. School of Medicine, HVTU — St Louis, Missouri, United States
• Miriam Hospital's HVTU — Providence, Rhode Island, United States
• Gaborone Prevention/Treatment Trials CRS — Gaborone, Botswana

Full record on ClinicalTrials.gov

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