Status:
COMPLETED
Safety of and Immune Response to the Experimental Preventive HIV Vaccine, EP HIV-1090, in Healthy, HIV-1 Uninfected Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to determine the safety of and immune response to the investigational HIV vaccine, EP HIV-1090, in HIV uninfected adults.
Detailed Description
The worldwide HIV/AIDS epidemic may only be controlled through the development of a safe and effective vaccine that will prevent HIV infection. DNA vaccines are inexpensive to construct, readily produ...
Eligibility Criteria
Inclusion
- Note: Groups 1, 2, 3, and 5 have permanently discontinued enrollment per the 12/26/06 letter of amendment.
- Good general health
- Have access to a participating HIV Vaccine Trials Unit (HVTU) and are willing to be followed for the duration of the study
- Willing to receive HIV test results
- Have understanding of the study
- Willing to use acceptable forms of contraception
- Negative pregnancy test
Exclusion
- HIV vaccines in a prior HIV vaccine trial
- Immunosuppressive medications within 168 days prior to first vaccination
- Blood products within 120 days prior to first vaccination
- Immunoglobulin within 60 days prior to first vaccination
- Live attenuated vaccines within 30 days prior to first vaccination
- Investigational research agents within 30 days prior to first vaccination
- Medically indicated subunit or killed vaccines within 14 days prior to first study vaccine administration, or allergy treatment with antigen injections within 30 days prior to first vaccination
- Current tuberculosis prophylaxis or therapy
- Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health
- Any medical, psychiatric, or social condition that would interfere with the study. More information about this criterion can be found in the protocol.
- Any job-related responsibility that would interfere with the study
- 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
- Active syphilis infection unless the participant has completed full treatment for syphilis 6 months prior to enrollment
- Unstable asthma
- Diabetes mellitus type 1 or 2
- Thyroid disease or thyroidectomy requiring treatment
- Serious angioedema within 3 years prior to enrollment
- Uncontrolled hypertension
- Body mass index (BMI) of 40 or greater
- BMI of 35 or greater if the participant is older than 45 years, has systolic blood pressure greater than 140 mm Hg, has diastolic blood pressure greater than 90 mm Hg, smokes, or has known hyperlipidemia
- 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 3 years prior to enrollment
- Absence of the spleen
- Mental illness that would interfere with the study
- Other conditions that, in the judgment of the investigator, would interfere with the study
- Pregnancy, breastfeeding, or plans to become pregnant
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00141024
Start Date
January 1 2006
End Date
December 1 2007
Last Update
October 14 2021
Active Locations (3)
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1
San Francisco Vaccine and Prevention CRS
San Francisco, California, United States, 94102-6033
2
Project Brave HIV Vaccine CRS
Baltimore, Maryland, United States, 21201
3
Univ. of Rochester HVTN CRS
Rochester, New York, United States, 14642-0001