Safety of and Immune Response to the Experimental Preventive HIV Vaccine, EP HIV-1090, in Healthy, HIV-1 Uninfected Adults
HIV Infections

About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Seronegativity, HIV Preventive Vaccine
Eligibility Criteria
Note: Groups 1, 2, 3, and 5 have permanently discontinued enrollment per the 12/26/06 letter of amendment. Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- San Francisco Vaccine and Prevention CRS
- Project Brave HIV Vaccine CRS
- Univ. of Rochester HVTN CRS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
1
2
3
4
5
Group 1 will receive 4 vaccinations of the EP-1043 vaccine or placebo. Vaccinations will be given at Months 0, 1, 3, and 6. This group was discontinued as of 12/26/06.
Group 2 will receive 4 vaccinations of the EP-1043 vaccine or placebo. Vaccinations will be given at Months 0, 1, 3, and 6. This group was discontinued as of 12/26/06.
In Part B, Group 3 will receive 4 vaccinations of either the EP-1043 vaccine or placebo. Vaccinations will occur at Months 0, 1, 3, and 6. This group was discontinued as of 12/26/06.
In Part B, Group 4 will receive 4 vaccinations of either the DNA vaccine EP-HIV-1090 or placebo. Vaccinations will occur at Months 0, 1, 3, and 6.
In Part B, Group 5 will receive 4 vaccinations of either the protein vaccine EP-1043 plus DNA vaccine EP-HIV- 1090 or placebo. Vaccinations will occur at Months 0, 1, 3, and 6. This group was discontinued as of 12/26/06.