A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of the Recombinant Protein Vaccine EP-1043 and the DNA Vaccine EP HIV-1090 Given Alone or in Combination in Healthy, HIV-1-Uninfected Adult Participants
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 84
- Locations
- 3
- Primary Endpoint
- Safety as assessed by local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse and serious experiences
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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 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. Participants will be enrolled in this study for 1 year. Group 4 participants will receive EP HIV-1090 or placebo at study entry and Months 1, 3, and 6. There will be 11 study visits that 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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Safety as assessed by local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse and serious experiences
Time Frame: After each injection and for 12 months following the first injection
Secondary Outcomes
- Social impacts as assessed by negative experiences or problems reported by the participants(Throughout the study)
- Immunogenicity as assessed by HIV-specific cellular responses assessed by interferon-gamma ELISpot assays and intracellular cytokine staining(Throughout the study)