HIV Infections Clinical Trial
Official title:
Development of an Oral Prime-Boost AIDS Vaccine to Elicit Broadly Neutralizing Antibodies Against HIV-1
NCT number | NCT00062530 |
Other study ID # | P01AI047490 |
Secondary ID | P01AI047490 |
Status | Not yet recruiting |
Phase | Phase 1 |
First received | June 9, 2003 |
Last updated | September 25, 2008 |
This study will test the safety of and immune response to an oral HIV vaccine in healthy volunteers. The vaccine in this study uses a weakened bacterium called Salmonella typhi to deliver an HIV gene into the body through the mouth. The body then produces an HIV protein from the gene; this protein stimulates an anti-HIV immune response. The vaccine contains only one of the many substances that HIV needs to make more copies of itself, so the vaccine itself cannot cause HIV or AIDS.
Status | Not yet recruiting |
Enrollment | 38 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria - HIV uninfected - Low risk sexual behavior - Negative for Hepatitis B surface antigen - Negative for Hepatitis C viral sequences and antibody - Availability for follow-up for planned duration of the study (12 months) - Acceptable methods of contraception Exclusion Criteria - Receipt of HIV vaccines or placebo in a previous HIV vaccine trial - History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications - History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure - Medical or psychiatric condition or occupational responsibilities which preclude compliance with the protocol - History of suicide attempts, recent suicidal ideation, or psychosis - High risk behavior for HIV infection as determined by screening questionnaire - History of injection drug use within 12 months of study entry - Live attenuated vaccines within 60 days of study entry. Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 2 weeks away from HIV immunizations. - Use of experimental agents within 30 days of study entry - Receipt of blood products or immunoglobulin within 6 months of study entry - Active syphilis - Active tuberculosis - History of anaphylaxis or serious adverse reactions to vaccines - History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension) - Pregnant or breastfeeding |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Institute of Human Virology | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety, as judged by the lack of an immune response to CD4 epitopes or other significant adverse events as defined by the HVTN toxicity tables | Throughout study | Yes | |
Secondary | Neutralizing antibody response against HIV-1 | Throughout study | No |
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