The purpose of the study is to determine the safety of and immune response to two investigational HIV vaccines, EP-1042 and EP HIV-1090, given alone or in combination in HIV uninfected adults.

Condition	Intervention	Phase
HIV Infections	Vaccine: EP-1043  Vaccine: EP HIV-1090	Phase I

Further Study Details: 

Primary Outcomes: Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse and serious experiences); immunogenicity (HIV-specific cellular responses assessed by interferon-gamma ELISpot assays and intracellular cytokine staining [ICS]); social impacts (negative experiences or problems reported by the participants)
Expected Total Enrollment:  120

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 produced in large quantities, and stable for long periods of time. EP HIV-1090 is a DNA HIV CTL vaccine; the proteins for which its genes code are designed to interact with CD8 cells (CTL) and cause CD8 cell proliferation. The DNA plasmids in EP HIV-1090 code for proteins conserved among HIV subtypes A, B, C, D, F, and G, which encompass the HLA subtypes of 85% of the worldwide general population. EP-1043 is a recombinant protein vaccine designed to interact with CD4 cells (HTL) and cause CD4 cell proliferation. Thus, it is hoped that both vaccines will provide a more potent, focused immunologic response to both the CTL and HTL arms of the immune system after they are administered.

Each participant will be enrolled in this study for 1 year. This study will comprise of two parts (A and B). There will be two groups (1, 2) in Part A; participants in Group 1, Part A will be enrolled sequentially into Group 1; after safety assessment, enrollment into Group 2, Part A will begin. All participants will be randomly assigned to receive vaccine or placebo. Group 1 participants will receive the low dose of EP-1043 or placebo at study entry and Months 1, 3, and 6. Group 2 participants will receive the higher dose of EP-1043 or placebo at study entry and Months 1, 3, and 6.

Part B will not begin enrollment until after safety data evaluation of Part A. There will be three groups in Part B; participants will be enrolled in parallel into one or another of these Part B groups (3,4, and 5), and will be randomly assigned to receive either the interventional vaccine(s) or their respective placebo(s). Those receiving EP-1043 (Group 3 of Part B) will receive the maximum tolerated dose of EP-1043 deemed safe in Part A. Group 3 participants will receive EP-1043 or placebo at study entry and Months 1, 3, and 6. Group 4 participants will receive EP HIV-1090 or placebo at study entry and Months 1, 3, and 6. Group 5 participants will receive both EP-1043 and EP HIV-1090 or their placebos at study entry and Months 1, 3, and 6.

There will be 11 study visits; they will occur at screening, study entry, and Months 0.5, 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12. A physical exam and risk reduction/pregnancy prevention counseling will occur at each visit. Participants will be asked about their adverse experiences from vaccination at each visit. Blood and urine collection will occur at selected visits.

Ages Eligible for Study:  18 Years   -   50 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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
• 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 judgement of the investigator, would interfere with the study
• Pregnancy, breastfeeding, or plans to become pregnant

Please refer to this study by ClinicalTrials.gov identifier  NCT00141024

Study chairs or principal investigators

Xia Jin, MD, PhD,  Study Chair,  University of Rochester   
Jorge Sanchez, MD,  Study Chair,  Asociación Civil Impacta Salud y Educación (IMPACTA)   

Study ID Numbers:  HVTN 064
Last Updated:  August 31, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00141024
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06